Sr MFG & Process DVL Engineer - Cable Assembly

Junior Counsel

Specialist, DEA Compliance

QC Supervisor

Patent Engineer Product and Technology Intelligence

Validation Engineer

QC Chemist I

Staff Software Engineer - Fullstack

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:Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing.Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.  Testing:Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.Perform methods development, transfer, verification and validation activities. Coordinate and assist with evaluation of Process Validations studies.   Documentation Practice, Training and Compliance:Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory.  Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.Lab Maintenance:Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.Monitor ordering of lab supplies.Enforce the control and management of controlled substances.  Staff Development: Evaluate potential candidates for QC; prepare annual performance evals. for chemists.   Prepare chemists and laboratory for FDA and other compliance audits.Ensures adequate resources are trained to support compliance and business initiatives.Requirements:Education & Experience:BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.7+ years of experience in pharmaceutical laboratory.2+ year QC supervisory experience preferred.Knowledge:Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.Skills & Abilities:Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.Good verbal and written communications with basic computer skills.Physical Requirements:Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment. Specific visions abilities are required by this job include close vision and color vision.The noise level in the work environment is usually moderate. The work environment is representative of a group laboratory environment. 

Responsibilities:As a Patent engineer Product & Technology Intelligence your focus will be to ensure the protection of company products and technologies.You will oversee the growth and maintenance of the various RRP, Conventional and other patent portfolios with a specific focus on Manufacturing.Specific Responsibilities Include:Actively define and implement a product and technology protection strategy.Catalyze the generation, identification and capturing of potential inventions, assess and value them, e.g. by scoring process, and recommend the protection mode.Drive the timely preparation and filing of invention disclosures with IP Law to meet relevant development timelines.Provide technical directions for the drafting and prosecution of patent applications to IP Law, ensuring accurate scope of the protection of the Smoke Free Products and other valuable inventions.Seek opportunities for identifying and capturing new inventions to broaden the protection scope.Ensure visibility and productive planning to overcome third party patent obstacles identified by IP Law, including coordinating and driving design-arounds and instructing technical teams on the path forward.Regularly report out monthly highlights and quarterly updates, giving insight into the Protection Coverage of the internal IP Portfolio.Requirements:Master’s degree or PhD in relevant subject: a driven and energetic engineer or scientist in a field that has substantial relevancy for the company Reduced Risk Product portfolio with a minimum of 4 years of experience in the industry.Demonstrable experience in engineering / science fields, Intellectual Property, Technology Management and Manufacturing Design, Creativity and Innovation Management in a multinational environment.It’s considered as a plus to be qualified or partly qualified as national or EP attorney.Ability to work in multi-functional and cross-cultural teams, know to deliver, to build bridges with various partners and know to communicate effectively.Capability to deal with ambiguity, sound judgement and diplomacy when delivering sophisticated and multifaceted messages.Fluency in English both verbal and in written form. Having knowledge of other languages is a plus.

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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8 dea form 222 Jobs found

Sr MFG & Process DVL Engineer - Cable Assembly

Junior Counsel

Specialist, DEA Compliance

QC Supervisor

Patent Engineer Product and Technology Intelligence

Validation Engineer

QC Chemist I

Staff Software Engineer - Fullstack

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8 dea form 222 Jobs found

Sr MFG & Process DVL Engineer - Cable Assembly

Junior Counsel

Specialist, DEA Compliance

QC Supervisor

Patent Engineer Product and Technology Intelligence

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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