- Actalent (Raleigh, NC)
- Description: The Batch Record Quality Specialist II will be responsible for conducting thorough reviews of manufacturing batch records for ... information is allocated into the proper sections of the record . These individuals will be doing a less technical...technical review as they will be focused on ensuring records are meeting quality standards for the… 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/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw ... materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron...advice in alignment with QA policies + Reviewing completed records and batch sheets and working with… more
- Abbott (Sturgis, MI)
- …and compliance to all Abbott policies, procedures, requirements, and government regulations + Elevate batch record quality issues to Quality Systems ... serve people in more than 160 countries. **Job Title:** Batch Records Auditor **Working at Abbott** At...ensure each is investigated prior to Production supervision or Quality Assurance specialist review + Identify and… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …tracking in the Batch Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging process (as applicable). + Coordinate ... review of medium to high complexity for all manufacturing batch records at appropriate stages in order...including coaching and mentoring operators and technicians on proper batch record documentation. + Lead and participate… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …tracking in the Batch Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging process (as applicable). + Prioritizes ... review of medium to high complexity for all manufacturing batch records at appropriate stages in order...including coaching and mentoring operators and technicians on proper batch record documentation. + Assists in training… more
- WuXi AppTec (Philadelphia, PA)
- …inspection of finished products for designated clients * Review and approved executed batch records * Review and approved deviation, non-conformance event (NCE) ... required to work on shift and be on-site. A Specialist role to provide Quality oversight in...and change control * Compile and review raw data, batch records and test results, including Final… more
- WuXi AppTec (Philadelphia, PA)
- …inspection of finished products for designated clients + Review and approved executed batch records + Review and approved deviation, non-conformance event (NCE) ... **Overview** A Specialist role to provide Quality oversight...and change control + Compile and review raw data, batch records and test results, including Final… more
- Randstad US (Burlington, MA)
- …requests, document approval, and document archival. + Issuance and reconciliation of paper records (ie, batch records , logbooks, protocols) + Manage the ... specialist , document control and records management....preferably in Sciences or Engineering + 7-10 years of Quality Assurance experience in pharmaceutical industry OR BS degree… more
- Actalent (Newark, CA)
- …inspections. The individual will also assist in quality operations area, such as batch record and quality control data review, line clearances, AQL ... quality operations, as needed (eg, review executed records such as batch records /...+ Other duties as assigned. Skills: Batch Record Review, capa, audit, document control, quality … more
- Randstad US (Cambridge, MA)
- …batch release of drug substance including compilation of documentation and review of batch documentation (ie batch records , deviations, in-process EM) - ... Perform review of the manufacturing batch records for completeness and compliance with...production operations including some or all of the following: batch release, SAP, batch record … more
- Abbott (Richmond, IN)
- … record reviews and prepare documentation for release of finished product + Conduct Quality Review of Batch Records /Work Orders in preparation for release ... 114,000 colleagues serve people in more than 160 countries. ** Quality Assurance Specialist - Richmond, IN** **Working...Foods, Acidified Foods, and Good Manufacturing Practices + Prepare batch records for Operations to utilize in… more
- Merck (Durham, NC)
- … Specialist , Quality Assurance is to assist in the review of batch records , media batch release, investigations, support of operational excellence ... and application of cGLPs and cGMPs. + Experience with batch release, and quality systems management; + Knowledge of LIMS **Preferred qualifications:** +… more
- Endo International (Rochester, MI)
- …and identify complex errors such as calculation conversions + Able to reconcile batch record entries with other documentation + Proof-reading skills and ability ... individuals to join our team. **Job Description Summary** The Quality Associate Specialist , Product Release, under close..., Product Release, under close supervision, reviews all pertinent records , including Batch Production Records … more
- Editas Medicine (Cambridge, MA)
- …and equipment as well as process commissioning & qualifications. + Review executed batch records , associated testing records , and other documentation to ... and review. + Author, review and approve GMP documentation (SOPs, batch records , protocols, technical reports, test methods, protocols, specifications,… more
- Randstad US (Norwood, MA)
- …8 AM - 4 PM education: Bachelors Responsibilities + Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), ... quality assurance specialist - gmp. + norwood ,...is required) + GMP + CAPA + Process Improvement + Batch Record Review + SAP + Veeva Qualifications… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …+ Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact + Identifying difficulties ... We are currently looking to fill a Quality Assurance Specialist position to support...+ Reviewing and approving MES recipes, design specifications, master batch records , and electronic records … more
- WuXi AppTec (Philadelphia, PA)
- …Specification Sheet (PSS) + Review and approves executed Aseptic Processing Validation (APV) batch records + Review and approves APV summary reports + Approves ... **Overview** Senior role to plan and implement quality requirements, provide Quality oversight in...COA's , COP's or COT's for executed Manufacturing batch records in accordance with cGMP and… more
- Unither Pharmaceuticals (Rochester, NY)
- Quality Specialist - Development & Validation Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products ... and Capsules. It has more than 280 employees. Your role Reporting to the Quality Assurance Manager, The Quality Specialist (Development and Validation)… more
- Randstad US (Norwood, MA)
- specialist , qa quality systems and distribution...similar quality document management + Experience performing batch record review and batch ... CMO batches, including Veeva documentation checks and SAP release steps. + Conduct batch record review as needed + Administration support for documentation… more