- ThermoFisher Scientific (St. Louis, MO)
- …**Environmental Conditions** Office **Job Description** **Job Title: Lead QA Technician - Batch Record Review and Release (Quality Associate 4)** At ... is a non-supervisory role, reporting to the QA Supervisor Batch Record Review and Release...QA review and disposition of executed production batch records . This position requires a highly… more
- BeiGene (San Mateo, CA)
- …quality is compliant with regulatory requirements and BeiGene standards. + Perform batch record review + Lead batch related deviation handling in ... changes at CMOs **Essential Functions of the job:** + Lead Small Molecule and Large Molecule commercial product quality...implementation at CMO + Manage change controls + Perform batch dispositions + Perform PIP (Person in Plant) +… more
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... of the Quality Assurance disposition team. The Quality Assurance Batch Disposition team assures patients worldwide of safe and...expected metrics to ensure timely release to market. + Lead , mentor and coach site personnel on quality matters… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Quality Assurance Specialist ( Batch Disposition) position. This position performs activities supporting dispositioning product ... and problem resolution + Participating in cross-functional meetings to achieve standard lead time targets for disposition of drug substance and drug product +… more
- United Therapeutics (Silver Spring, MD)
- …targets + Work on complex assignments per written procedures and batch records with limited supervision + Review and/or execute related process documentation ... development on technical transfer issues and may support and/or lead areas for process improvement + Review ...Write and review area SOPs and Production Batch Records + Perform and/or supervise daily… more
- BioFire Diagnostics, LLC. (Lombard, IL)
- …this individual will be responsible for preparation, distribution, reviews, of batch records and other documentation required for routine production. ... tasks in to meet batch processing timelines. + Perform routine reviews of Batch Records and coordinate completion of corrections to ensure adherence to … more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …to procedures and policies, including coaching and mentoring operators and technicians on proper batch record documentation. + Lead and participate on safety ... Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging...+ Perform Change Controls + Identify, implement and execute SOP/Form/ Batch Record revisions + Lead … more
- Integra LifeSciences (Plainsboro, NJ)
- …around start/stop, breaks and timely completion of tasks Paperwork + Obtain batch records in advance for associated manufacturing operations to prevent ... to keep manufacturing operations on track and progressive + Provide comments in batch records not limited to non-conformance references or other clarifications +… more
- ThermoFisher Scientific (Bend, OR)
- …process trains. Review , approve, and update quality documents. Implement Production Batch Records to produce pharmaceutical products. Review implemented ... Batch Records for compliance before QA review . Assist with schedule adherence by prioritizing daily tasks....team members. Serve as a backup for the Team Lead as needed. Support new equipment commissioning and qualification… more
- Merck (Durham, NC)
- …and reports issues with product accountability and SAP system discrepancies. + Executes real-time batch record review and is responsible for alarm monitoring ... team finishes design and construction of the facility, the Lead Technician will play a critical role in supporting... review , and/or edit operations and technical documentation ( Batch Records , SOPs, Job Aids, training, and… more
- Bristol Myers Squibb (Bothell, WA)
- …train and mentor junior team members. **Knowledge & Skills:** + Hands-on experience with batch record review and product disposition. + Strong computer ... Saturday, Onsite 9 pm - 7:30 am **Responsibilities:** + Review executed batch records to...approval. + Minimum of 1 year of experience with batch record review . **Preferred Requirements:**… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …and activities associated with batch record documentation, reviewing and approving batch records , and releasing batch records and finished ... Manufacturing Practices" and SOPs related to batch record documentation and release. + Act as lead...Operations. + Interact with customers regarding questions, issues, metrics, batch records , etc; Respond to and investigate… more
- Merck (Rahway, NJ)
- …facility. **Responsibilities of the role include but are not limited to:** + Lead , prepare for and/or support batch processing readiness and execution ... and organizational skills. + Desire and willingness to learn, contribute, and lead . + Track- record of independent problem-solving. **Preferred Experience and… more
- Lilly (Durham, NC)
- …of daily operations such as: + Cycle Summary Reports for equipment + Electronic batch record initiation + Daily documentation of quality on the floor oversight ... oversight of Indianapolis Parenteral Operations activities. The QA Floor Lead Tech is responsible for providing daily support and...such as: + SAP (inventory management) + PMX (electronic batch record ) + TrackWise (compliance + Veeva… more
- Catalent Pharma Solutions (San Diego, CA)
- …responsibilities of this position include activities related to supply chain, procurement, batch record and label creation, and other project management and ... project source documentation with client input. Support creation of batch records based on project source documentation...Work Order creation, Clinicopia, and GSA set up. Provide batch record training to production team on… more
- Catalent Pharma Solutions (Madison, WI)
- …members on complex production activities + Coordinates implementation of SOP and batch record updates, ensuring operator awareness and planning training where ... ** Lead Associate - Biomanufacturing, Downstream** Catalent is a...substance filling, and column packing/qualification + Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating… more
- Merck (Durham, NC)
- … and approval of batch record documentation (electronic batch record comment resolution, autoclave records , review and approval of electronic and ... during processing, review and approval of incursions, review and approval of batch record...paper batch records as applicable) + Provide Quality oversight to alarm… more
- Lilly (Concord, NC)
- …site procedures. + Review and approve GMP documentation such as electronic batch records , logbooks, etc. + Support creation of Standard Operating Procedures ... inspection + Previous experience with Manufacturing Execution Systems (MES) or electronic batch records + Previous technical writing experience + Technical… more
- ICU Medical (Austin, TX)
- …cabinets (BSC). *Generate and maintain accurate manual (hardcopy) documents such as batch records and other controlled worksheets and electronic laboratory ... - Exempt *Position Summary* The EQ Analyst III (Lab Lead ) is responsible for performing routine and non-routine testing...records of tasks completed and review and/or verify the results of other laboratory personnel… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …may be for you if you: + You have previous QA operations experience, particularly with batch record review / MES design, implementation or training + You are ... IT to troubleshoot problems associated with QA functions + Support/ lead efforts to establish new programs including start-up of... Review and approval of documents including executed Batch Records and SOPs (electronic and paper-based)… more