- Randstad US (Novato, CA)
- qa operations associate - batch record review . + novato , california + posted september 11, 2024 **job details** summary + $34.23 - $40.27 per hour + ... can include but is not limited to logbooks, production batch records and electronic buffer & media...(eg, scanners, printers). SQL, as a plus. Required + BATCH RECORD REVIEW + QA… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Supervisor Quality Assurance ( Batch Record Review ) position. This position performs activities supporting dispositioning ... associated with disposition of raw materials and product (eg receipt, inspection, document review , shipping, etc.), activities may be on the floor or at a desk… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. + Review batch record to support release of raw materials, work in ... **Overview:** The Quality Systems Specialist is responsible for reviewing records to comply with QSR and ISO requirements. They...signing in relevant sections of documents. + Reviewing the batch records online, if necessary. + … more
- Abbott (Altavista, VA)
- …+ Provide support for data collection, ie: PQA lab, Engineering and DQA. + Expedite batch review when asked by Division to meet consumers' demands. + Assist ... world by Fortune. + **A stable company** with a record of strong financial performance and history of being...families around the world. **What You'll Work On** + Batch audit: Review work orders for completeness… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …Providing consultation or advice in alignment with QA policies + Reviewing completed records and batch sheets and working with other departments and communicate ... guidance on QA procedures and polices as well as review of documents for both internal and external transfers...Performing activities associated with disposition of product (eg document review , shipping), activities may be on the floor or… more
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... be a member of the Quality Assurance disposition team. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and… more
- BeiGene (Hopewell, NJ)
- …Responsibilities:** + Supervises direct reports within the Manufacturing QA Team, assist with batch review and release, as necessary. QA, Mfg. shop floor QA ... availability of adequate competent resources to carry out the review and approval of batch documentation and...Quality Operations on the shop floor. + Demonstrable track record and skills/experience gained within a similar position(s), at… more
- Curia (Albuquerque, NM)
- …biotechnology industries. The Quality Program Management Manager will lead and manage our QA batch record review and product disposition team. The manager is ... the timely review and disposition of executed batch records (clinical, commercial, and media fills)....supply commitments. Key responsibilities include establishing, monitoring, and improving batch record review and disposition… more
- Boulder Scientific Company (Mead, CO)
- …and quality assurance into all batch records + Participates in Process Review meetings and Batch Record Review meetings during process ... includes converting R&D Lab Write-ups to Pilot Plant Master Batch Records and updating existing Pilot Plant...Record Briefings and Debriefings + Edits and revises Batch Records as requested by R&D or… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The Quality Assurance Document Control ... Document Control individual is responsible for preparing customer files, review and approve batch records ,...practices experience strongly preferred + Experience with inspections or batch record review a plus… more
- Actalent (Coral Springs, FL)
- Job Title: Quality Assurance Specialist Job Description * Review executed batch records and all related documentation for manufacturing activities in ... Compile and review all applicable documentation for batch review and release, keep track and...and internal audits. * Keep track of data and records review indicators for internal quality metrics… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... procedures for upstream, downstream, and solution preparation manufacturing using SOP's and batch records . Operating production equipment in support of all drug… more
- PCI Pharma Services (Philadelphia, PA)
- …individual will contact the appropriate personnel to recalibrate and/or remediate the issue. Review batch record (MPI) to ensure equipment challenges and ... when the audit was conducted. Identify proactively gaps in batch records and PDRs to mitigate deviations...QA inspectors/auditors, batch record preparation, batch record review , document change… more
- Merck (Durham, NC)
- …of operations on the production floor, coordination across processing suites, real-time batch record review , execution of aseptic processing requirements ... Executes operational review and comment resolution of batch records to include binder assembly. +...and SAP system discrepancies. + Assists team in real-time batch record review and ensures… more
- Kelly Services (Round Lake, IL)
- …the Manufacturing functional areas. This position provides the Manufacturing documentation review . Review the batch record or any other GMP document to ... batch documentation review . * Responsible for ensuring manufacturing's batch records meet specifications and submitted to Quality per release schedule *… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive ... organizing internal and customer approval of batch records and specifications. + Assist with performing record...information. + Assist in the preparation of annual product review data. + Assist with generating and presenting quality-related… more
- Bristol Myers Squibb (Devens, MA)
- …routine reviews and approvals of GxP documents including, but not limited to electronic batch record review , and logbooks; executing operational tasks in the ... electronic batch records such as, but not limited,...quality principles. + Prior experience with quality processes, including batch record review , material disposition,… more
- BeiGene (San Mateo, CA)
- …ensure the product quality is compliant with regulatory requirements and BeiGene standards. + Perform batch record review + Lead batch related deviation ... implementation at CMO + Manage change controls + Perform batch dispositions + Perform PIP (Person in Plant) +...Vendor Management team on vendor performance monitoring and periodic review , support in audits as required + Will work… more
- Honeywell (Buffalo, NY)
- …in place through review and approval of procedures including master batch records , specifications and standard operating procedures impacting the safety, ... in support of GMP operations. Release or reject product based on detailed review of batch records and final product quality. Work closely with members of… more
- ADM (Kansas City, KS)
- …inter-org transfers. + Provide copy monthly to plant personnel and address past dues. + Maintain batch review report. + Print batch review report weekly, ... and greet incoming visitors. + Driver sign in + Review and enter all receiving paperwork into Oracle daily....oracle daily. + Ship confirm orders daily. + Enter batch sheets from previous day production. + Enter bag… more