Operation Supervisor

Lead Quality Specialist - Investigator

Java Backend Engineer

118762 Sr MFG & Process DVL Engineer - Cable Assembly

Junior Counsel

Specialist, DEA Compliance

Validation Engineer

QC Chemist I

Staff Software Engineer - Fullstack

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>

Job Summary: <ul><li>Design and develop manufacturing process, tool, fixture and related equipment for cable assembly as project schedule with the objective of ensuring the whole manufacturing process is competitive and meet cost target within the direction of department manager and project manager.&nbsp;</li><li>Design and develop manufacturing process for new project/product, meet CoPQ and delivery target.</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.&nbsp;</li><li>5 years’ working experiences in related field.</li><li>Good coordination and communication skill, accountability, integrity, customer focus.</li></ul>

Responsibilities: <ul><li>This role supports the Legal &amp; Privacy Head’s daily functions and is a strong ambassador to the trusted ‘gate-keeper’ objectives across sales, marketing, operations, purchasing and other business stakeholders.&nbsp;</li><li>The activities include handling the day-to-day legal team administration linked to business needs.</li><li>Co-ordinate the roll-out of legal / compliance training across all regional hub offices with key focus across commercial, purchasing, and regulatory forms related to the distribution of consumer goods globally in Chinese and English.&nbsp;</li><li>Knowledge of the travel retail distribution channel an advantage.</li><li>Multi-task and be organised across various delegations, ‘ad-hoc’ administrative tasks and assignments.</li><li>Take part in developing internal control initiatives whilst anticipating legal and reputational risks, actively listening, reviewing, and drafting forms, as required.</li><li>Develop and roll-out contract life cycle processes with company stakeholders to finalise forms externally.&nbsp;</li><li>Constructively challenging the status-quo and breaking barriers for effective ‘ways-of-working’.</li><li>Facilitate various projects through the co-ordination, drafting forms and checking thoroughly the processes for compliance.</li><li>Have attention to detail with a proven ability to optimise limited business resources, work collaboratively with different cultures and adapt to agile ways-of-working.</li></ul>&nbsp;Requirements: <ul><li>2 to 4 years of work experience with relevant university qualifications in Law.&nbsp;</li><li>Additional qualifications in business, political science, tax, compliance, languages and communications, will be highly regarded.</li><li>Mandarin Chinese (written + spoken, preferably) to assist in China Hub local form review and staff training.</li><li>Detail-oriented, self-starter and comfortable working independently (in a small team setting) with relevant private practice training and in-house work experience, having proven stakeholder management with a ‘can-do’ mindset.</li><li>Strong awareness and interest in the business of luxury and FMCG brands. Has an entrepreneurial mindset with curiosity across all aspects of B-2-B retail and the end-consumer journeys. Knowledge of the digital marketing and social platform space (i.e., AliPay, Douyin, WeChat, Weibo, Ctrip, etc.) is an advantage.</li><li>Displaying strong awareness over legal issues and curiosity on global consumer trends in the Asia-Pacific region (i.e., digital retail, data-privacy protections, competition, bribery/corruption, customs/trade, etc.).</li><li>Direct mentorship opportunities from daily business interactions across the organisation as well as continuous professional development offered on various topics (i.e., business, soft-skills, etc.)</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.

Responsibilities: Provide technical leadership and guidance to a team of software engineers, fostering a culture of collaboration, innovation, and continuous improvement. Demonstrate end-to-end ownership of features, projects, modules, and services that you and your team deliver in all phases of the software development lifecycle. Lead your team’s design and implementation of end-to-end solutions towards client-side applications using JavaScript, Node.js, React, GraphQL, and other relevant technologies. Lead architectural discussions and contribute to the overall technical direction of the client-side applications, advocating for best practices and innovative solutions. Optimize software performance, identifying and resolving bottlenecks via monitoring, logging, and metrics to enhance the user experience. Act as a strong advocate for clean, scalable, high-performing, secure, and reliable software services, in all areas, including coding, documentation, automation, etc. Identify and implement critical non-functional requirements (Availability, Security, Performance, Scalability, and Observability), and improve automated test strategies, build and deploy processes to enable speedy and reliable continuous integration. Collaborate with other development teams to ensure seamless integration and deployment of client-side applications, automating and enhancing build, test, and deployment processes. Communicate effectively with all technical and non-technical partners and stakeholders (Architecture, Developer Experience, Product, Design, Analytics, Legal, Marketing, etc.) as well as within your team to ensure shared understanding around the new products and features under consideration. Conduct formal and informal code reviews, providing constructive feedback to team members to ensure code quality and adherence to clean and scalable coding principles. Mentor and guide junior engineers, fostering their professional growth and promoting a collaborative and knowledge-sharing environment. Stay up-to-date with the latest industry standards, tools, and technologies related to client-side development, observability, and DevOps practices, and drive their adoption within the team. Participate in program planning, influencing the product and technology roadmap and driving outcomes. Requirements: 6+ years of professional experience in software development, with a strong emphasis on the development of large-scale and performant Web applications. High proficiency in JavaScript, Node.js, React, GraphQL, or similar frameworks and libraries.  Solid understanding of the possibilities and limitations of the modern web across all device types and form factors  Experience in building responsive, accessible, and mobile-friendly user interfaces  Strong attention to detail, as well as a passion for delivering high-quality software solutions and compelling customer experiences Strong problem-solving skills, possessing the ability to work independently or collaboratively to analyze and address complex technical challenges  Ability to mentor and up level team members  Excellent communication skills with the ability to collaborate effectively with cross-functional teams and those in non-technical roles, such as marketing, finance, and legal Experience with modern software development practices, version control systems, and agile methodologies 

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9 dea form 222 Jobs found

Operation Supervisor

Lead Quality Specialist - Investigator

Java Backend Engineer

118762 Sr MFG & Process DVL Engineer - Cable Assembly

Junior Counsel

Specialist, DEA Compliance

Validation Engineer

QC Chemist I

Staff Software Engineer - Fullstack

WhiteCrow
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9 dea form 222 Jobs found

Operation Supervisor

Lead Quality Specialist - Investigator

Java Backend Engineer

118762 Sr MFG & Process DVL Engineer - Cable Assembly

Junior Counsel

Specialist, DEA Compliance

Validation Engineer

QC Chemist I

Staff Software Engineer - Fullstack

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

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