- Corcept Therapeutics (Menlo Park, CA)
- …met, investigation/deviations are closed in a timely manner, and facilitate batch release . Preferred Skills, Qualifications and Technical Proficiencies: ... Assist with Supply Chain, Analytical, and Stability activities as needed. Review /approve documents associated with Drug Product development and manufacturing, such… more
- Dennis Partners (Boston, MA)
- …the Head of QA, as needed, oversee the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and ... including development and filing of associated regulatory submissions.Ability to review , understand and explain the regulations and guidance documents to… more
- San Francisco (San Francisco, CA)
- …to prepare for commercialization for both US and EU. Write and/or review technical documents including development reports, tech transfer reports, manufacturing ... batch records, campaign summary reports, risk assessment, and deviation...across the vendor network to support in-process testing, lot release , stability, shelf-life extensions, and product safety. Partner with… more
- Antares Pharma (San Diego, CA)
- …the opportunity to:Ensure CMO compliance with all applicable cGMP regulations, batch records, validated processes, QC testing requirements, and data integrity. ... Review Annual Product Quality reporting for products within scope.Lead...and improvements of, existing products and processes and the release of new products.Support QA lot disposition with technical… more
- Novo Nordisk (West Lebanon, NH)
- …with direct/indirect referral: none Essential Functions + Perform activities to support Batch Release + Coordinate with Supply Chain Planning to ensure ... running Release performance board + Manage applicable batch release checklists using Styx + Verify...Release of Formulation batches/Production support batches + Timely review of monthly critical logs o Water/Clean steam … more
- Lilly (Indianapolis, IN)
- …**Position Brand Description:** The (Sr.) Principal Associate/Advisor QA - Qualified for Batch Release is responsible for final disposition of Active ... The (Sr.) Principal Associate/Advisor - QA - Qualified for Batch Release ensures that all batches meet...quality support of API with the focus on holistic review of key activities associated with or impacting the… more
- Novo Nordisk (Durham, NC)
- …25th, 2025. Scope of Position The Quality Assurance (QA) Intern will join our Batch Release group for the summer. This internship provides an excellent ... Accountabilities + Conduct research, gather, and analyze data, prepare and/or review documents, reports and/or presentations + Learn and support relevant processes,… more
- Boehringer Ingelheim (Athens, GA)
- …by SOP. + Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release . + Performs review and approvals of APHIS Form ... this position is review and approvals of batch records, government release documentation and ...of product as needed. + Performs usage decisions for batch release in SAP + Performs second… more
- BeiGene (Hopewell, NJ)
- …management of: Material and Product Release floor activities, material complaints, Batch Release Key processes and QA objectives, whilst adhering to ... Person, interacts with EU QPs as needed for European batch release . + Support QA floor activities...availability of adequate competent resources to carry out the review and release of materials and product… more
- West Pharmaceutical Services (Scottsdale, AZ)
- …Review metrology data and ensure other input documentation required for batch release is up to date. * Communicate review results to Production and ... Product Release Specialist Requisition ID: 66626 Date: Sep 15,...this role, the employee will be responsible for the review and approval of batch production records… 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 ... progress and final products. This includes reagents, components and instrumentation-related products to ensure they are on the right path. + Generate standard operating procedures to define and improve quality system functions. **Qualifications:** The… more
- BeiGene (Hopewell, NJ)
- …events requiring documented review and action. + Ensuring that the QA batch release function meets or improves key performance indicators (KPIs). + ... Responsibilities:** + Supervises direct reports within the Manufacturing QA Team, assist with batch review and release , as necessary. QA, Mfg. shop floor QA… more
- PCI Pharma Services (Rockford, IL)
- …documentation. 7. Assist with providing quality related metrics. 8. Performs finished product batch release of approved production lots. 9. Meet with management ... documentation for requested production work orders. 2. Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer… more
- PCI Pharma Services (Rockford, IL)
- …documentation. 7. Assist with providing quality related metrics. 8. Performs finished product batch release of approved production lots. 9. Meet with management ... documentation for requested production work orders. 2. Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer… more
- Catalent Pharma Solutions (Morrisville, NC)
- …Assurance and other functional areas to ensure timely closure of designated batch release investigations; interact with Production personnel on continuous ... Production department executes, completes, and reviews all associated master batch record documentation; creates and reviews standard operating procedures; creates… more
- Lilly (Indianapolis, IN)
- …maintained. The Authorized Quality Representative (AQR) in IPM is responsible for final batch release of Semi-Finished and supports and assists the plant quality ... for supporting all HSE Corporate and Site Goals. * Performs final batch disposition of semi-finished drug product batches for Indianapolis Parenteral products,… more
- Verista (Boston, MA)
- …facility including start-up of assembly, packaging and label operations + Responsible for batch disposition activities. Review batch data, including batch ... to determine acceptability of product disposition. + Responsible for review and approval of COAs, and product release...QA support and oversight of GMP manufacturing operation including batch release + Experience with ATMP drug… more
- PCI Pharma Services (Rockford, IL)
- …document-related issues with other departments and customers. + Performs finished product batch release of approved production lots. + Attend conference calls ... standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains...following but other duties may be assigned. + Primary reviewer for master batch records, forms, and… more
- WuXi AppTec (Philadelphia, PA)
- … records for assigned clients * Review and approve executed Manufacturing batch records. * Prepare Manufacturing release checklist and COA's * Stay current ... being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances,...in accordance with cGMP. Prepare Certificate of Analysis for batch release . Details: + 100% Onsite at… more
- WuXi AppTec (Philadelphia, PA)
- …deviations, and CAPAs in accordance with cGMP. Prepare Certificate of Analysis for batch release . **Responsibilities** + Review and approve low-risk ... being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances,...clients + Review and approve executed Manufacturing batch records. + Prepare Manufacturing release checklist… more
