Software Engineer, Quality Analyst

Cable Assembly - Senior MPD Engineer 

Quality Control Supervisor

Developer and Integration Specialist

Operation Supervisor

Lead Quality Specialist - Investigator

Java Backend Engineer

Specialist, DEA Compliance

Validation Engineer

QC Chemist I

Responsibilities: <ul><li>Understand the test requirements and getting the team aligned with the same.&nbsp;</li><li>Participating on all technical aspects, interacting with client for all technical inputs and queries.&nbsp;</li><li>Automation and integration of complex processes.&nbsp;</li><li>Work closely with the development team on becoming the SME of the product.&nbsp;</li><li>Strong Testing Fundamentals , testing tools, reporting and frameworks.&nbsp;</li><li>Build and maintain the automation regression suite for the white box testing of the products.&nbsp;</li><li>Participate in requirement grooming and think form end customer perspective.&nbsp;</li><li>Should own all aspects of Testing, QA Framework for existing Products and Product end-to-end testing across functional, Security and Automation.&nbsp;</li><li>Work in a dynamic Agile environment and come up with solutions to meet project needs.&nbsp;</li><li>Communicate with Client and end customers in written and verbal.&nbsp;</li><li>Should be able to interact with client and customers for Escalated Customer Issues/Bugs.&nbsp;</li></ul> ﻿Requirements: <ul><li>Manual/Automation Testing - DataCom (Networking , Security, L2-L3, L4-L7 Protocols)&nbsp;</li><li>Hands on experience on Networking products Switch Router and Firewall&nbsp;</li><li>Good testing experience in Datacom/IP-Networking/Switching/routing domain.&nbsp;</li><li>Knowledge of Networking (L2/L3 protocols)&nbsp;</li><li>Knowledge of Testing tools : IXIA/SPIRENT&nbsp;</li><li>Security testing tool - Nessus, OpenVas, Achilles, Defensics (Anyone)&nbsp;</li><li>preferably knowledge / hands on in traffic generation tools such as IXIA or Spirent,&nbsp;</li><li>Performance and scalability testing, security, Penetration testing. packet sniffing tools.&nbsp;</li><li>Linux/containers Knowledge&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.&nbsp;</li><li>CI/CD: Jenkins, GitHub, Bitbucket Actions&nbsp;</li><li>Scripting: Python and/or Shell is a must&nbsp;</li><li>Working experience in Routing protocols such as RIP, OSPF, BGP, MPLS VRRP&nbsp;</li><li>Good understanding of Management interface such as SNMP, Web, Yang, Netconf, Rest based interfaces etc&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li><li>Strong written and oral communication skills.&nbsp;</li><li>High levels of motivation with a can-do attitude.&nbsp;</li></ul>

Responsibilities: Manufacturing Process Development: <ul><li>Define, review and confirm the entire manufacturing process from start to finish.</li><li>Coordinate Design for Manufacturing (DFM) review, and initiate Process Failure Modes and Effects Analysis (PFMEA) with core team members.</li><li>Prepare documentations and process specifications for production.</li><li>Lead team in identification, tracking and resolution of engineering issues using the Failure Analysis and Corrective Action (FACA) form.</li><li>Continuous manufacturing process improvement with company OA tools for cost reduction.</li></ul> Assembly Tool, Fixture and Equipment Development: <ul><li>Evaluate new tool, fixture, and equipment demand/cost for new projects.</li><li>Design and review the tool, fixture and equipment with core team members meeting company engineering and EHS requirement.&nbsp;</li><li>Upload all tooling prints to company data management system(DM.TEC, PDMLink, etc.)</li><li>Discuss and review details of tool/fixture/equipment with outside supplier.</li><li>Follow up the purchasing process to fabricate new tool/fixture/equipment.</li></ul> Qualification for Manufacturing process, Tool, Fixture, and Equipment: <ul><li>Condition all tool, fixture and equipment, lead the tool/fixture/equipment qualification by running samples or LVM.&nbsp;</li><li>Follow up the documentations for qualification, using company standard format and follow up the approval.</li><li>Coordinate pilot run for new products and solve engineering issues, make sure the manufacturing process capability meet engineering, quality and customer requirement.</li></ul> Technician Guidance: <ul><li>Coach, train and develop operator and technician in order to ensure their technique could be succeed and get continuous upgraded.</li></ul> Requirements: <ul><li>Bachelor degree or above. Mechanism engineering related background. </li><li>5 years’ working experiences in related field.</li><li>Good coordination and communication skill, accountability, integrity, customer focus.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Develop IT programs that meet defined business requirements per specification documentation</li><li>Work with IT Business Analysts and customers to understand business users’ requirements for new workflow, reports, interfaces/APIs, enhancements, conversion programs and forms</li><li>Develop and deploy SAP artifacts within the landscape, inclusive but not limited to programs, function modules, interface classes, IDOCs, DDIC objects and other requisite objects within</li><li>the application server ABAP environment</li><li>Develop and deploy SAP Fiori Applications and Services, complimented with OData service development</li><li>Lead innovative and transformative projects leveraging No/Low Code architectures within the public cloud ecosystem including Power Automate, Logic App, SAP Business Technology Platform.</li><li>Refactor existing ABAP applications into their modern BTP equivalent</li><li>Employ the latest coding practices and principles working with SAP HANA and SAP applications developed for SAP HANA</li><li>Develop and deploy API solutions within iPaaS architectures, optimizing for internal/external communication and interface usage</li><li>Code, test, analyze and implement new applications and changes to existing applications</li><li>Develop and maintain appropriate documentation including System Design and Technical Documentation</li><li>Assist in the documentation of all enhancements including comprehensive flowcharts, system configuration and technical artifacts deployed</li><li>Assist project managers and IT Solution Architect on estimations for development efforts</li><li>Perform requisite support of the global application footprint, in line with Service Level Agreements, which may require 24/7 on-call support</li><li>Assist as a mentor to fellow staff developers</li><li>Ensure that technical activities throughout the development lifecycle maximize the use of standards / best practices / solutions and minimize customization</li></ul> Requirements: <ul><li>Bachelor’s Degree or equivalent preferred</li><li>Background in Computer Science, Engineering, Business, or related discipline&nbsp;</li><li>General IT experience: Minimum 10 years’ direct experience working and developing in distributed computing technologies, with experience in system design, trouble shooting, andprogramming in a 4GL language</li><li>SAP Experience: Minimum 7 years’ hands-on experience in SAP ABAP, including structured programming.</li><li>API Experience: Preferred experience with Jitterbit Harmony, or other API solution such as Mulesoft or Boomi.</li><li>Experience developing UI5, SAP Fiori and Core Data Service Views for SAP S/4 HANA</li><li>Working knowledge of the SAP Business Technology Platform/Business Application Studio</li><li>ABAP and the SAP developer’s workbench, SAP HANA Studio &amp; ADT, SAP Business Application Studio (BAS) and SAP Business Technology Platform (BTP)</li><li>Ability to transform business function requirements into technical program specs, and to code, unit test and debug customer and standard application programs</li><li>Write custom ABAP reports for SAP S/4 HANA</li><li>Advanced experience with SAP IDOC’s, BAPI’s, user-exit reports, ABAP workbench, ABAP objects, user-exits, dialog programming, reporting, Multi-level reporting/interactive, and data dictionary objects.&nbsp;</li><li>Experience with SAPscript, SmartForm and Adobe Form Development</li><li>Experience with ALE, Remote Function Call and general API Development</li><li>Understanding of SAP enhancement framework</li><li>Understanding of SAP Fiori &amp; OData service framework in SAP</li><li>Understanding of relational databases, data storage and SQL concepts</li><li>Understanding of API frameworks and protocols</li><li>Ability to provide accurate and timely project management information</li><li>Excellent verbal and interpersonal communication skills for working with the functional teams, development specialists, and the SAP support team. Must have solid written skills to support</li><li>program documentation</li><li>Ability to produce high quality deliverables and work in an environment with competing priorities. Can multi-task effectively. Demonstrates results-orientation, initiative and strong work</li><li>ethic; ability to master tactical details</li><li>Demonstrated ability to proactively identify improvement opportunities and initiate change</li><li>Demonstrated ability to quickly acquire new technology skills</li><li>Experience in Food or CPG (consumer packaged goods) a plus</li><li>A customer-focused service attitude</li><li>Good organizational skills, with the ability to meet objectives</li><li>Excellent technical documentation skills</li></ul>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Responsibilities: <ul><li>Collaborate with team, high availability, concurrent and fault tolerant software systems.</li><li>Significantly contribute to development of Aladdin’s global, multi-asset trading platform.</li><li>Work with product management and business users to define the roadmap for the product.</li><li>Design and develop innovative solutions to complex problems, identifying issues and roadblocks.</li><li>Apply validated quality software engineering practices through all phases of development.</li><li>Ensure resilience and stability through quality code reviews, unit, regression and user acceptance testing, dev ops and level two production support.</li><li>Be a leader with vision and a partner in brainstorming solutions for team productivity, efficiency, guiding and motivating others.</li><li>Drive a strong culture by bringing principles of inclusion and diversity to the team and setting the tone through specific recruiting, management actions and employee engagement.</li><li>For VP Level: In addition to above, a VP level candidate should be able to lead individual projects priorities, deadlines and deliverables using AGILE methodologies.</li></ul> Requirements: Qualifications: <ul><li>B.S. / M.S. degree in Computer Science, Engineering, or a related subject area</li><li>For VP Level: 8+ years of proven experience</li><li>For Associate Level: 4+ years of experience</li></ul> Skills and Experience: <ul><li>A proven foundation in core Java and related technologies, with OO skills and design patterns</li><li>Track record building high quality software with design-focused and test-driven approaches</li><li>Good hands-on object-oriented programming knowledge in Java, Spring, TypeScript, JavaScript, Microservices, Angular (2.0+), React.</li><li>Strong knowledge of Open-Source technology stack (Spring, Hibernate, Maven, JUnit, etc.).</li><li>Experience with relational database and/or NoSQL Database (e.g., Apache Cassandra)</li><li>Great analytical, problem-solving and communication skills</li><li>Some experience or a real interest in finance, investment processes, and/or an ability to translate business problems into technical solutions.</li><li>For VP Level: In addition to the above, a VP level candidate should have experience leading development teams, projects or being responsible for the design and technical quality of a significant application, system, or component. Ability to form positive relationships with partnering teams, sponsors, and user groups.</li></ul> Nice to have and opportunities to learn: <ul><li>Exposure to building microservices and APIs ideally with REST, Kafka or gRPC.</li><li>Experience working in an agile development team or on open-source development projects.</li><li>Experience with optimization, algorithms or related quantitative processes.</li><li>Exposure to high scale distributed technology like Kafka, Mongo, Ignite, Redis</li><li>Experience with Cloud platforms like Microsoft Azure, AWS, Google Cloud</li><li>Experience with DevOps and tools like Azure DevOps</li><li>Experience with AI-related projects/products or experience working in an AI research environment.</li><li>A degree, certifications or opensource track record that shows you have a mastery of software engineering principles.</li></ul>

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

Responsibilities:The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.They will work with quality, technical operations and production to identify and resolve issues. Adhere to all company and cGMP procedures as well as applicable safety regulations.Author change controls, SOPs and protocols.Protocols o Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.Responsible for confirming all communicated validation plans to applicable management.Provides technical assistance in the form of rationales or validation studies.Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.Troubleshoots and resolves issues as needed.Manage multiple projects with competing deadlines.Manage external resources to complete tasks outside SPI’s capabilities. Manage approvers of documents and procedures and ensure timely closure of tasks.Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.Source and procure equipment, supplies and other materials as needed.Develop and maintain cross-functional relationships. Requirements:Bachelor of Science in Engineering or Science discipline preferred.Experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries.In-depth knowledge of the pharmaceutical plant operations is an asset.Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the JobExperience authoring change controls in Trackwise or other management system.Experience authoring SOPs in MasterControl or other management system.Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions. People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.Climb ladders and work in high, precarious places up to elevations of 75 feet.Regularly exposed to work near moving mechanical parts.Exposed to wet or humid conditions.Exposed to outdoor weather conditions.Regularly exposed to high noise environments.Exposed to extremely dusty environments.Exposed to chemicals used in the manufacturing process.

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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11 dea form 222 Jobs found

Software Engineer, Quality Analyst

Cable Assembly - Senior MPD Engineer

Quality Control Supervisor

Developer and Integration Specialist

Operation Supervisor

Lead Quality Specialist - Investigator

Java Backend Engineer

Specialist, DEA Compliance

Validation Engineer

QC Chemist I

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11 dea form 222 Jobs found

Software Engineer, Quality Analyst

Cable Assembly - Senior MPD Engineer

Quality Control Supervisor

Developer and Integration Specialist

Operation Supervisor

Lead Quality Specialist - Investigator

Java Backend Engineer

Specialist, DEA Compliance

Validation Engineer

QC Chemist I

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.