- Integra LifeSciences (Columbia, MD)
- …Tissue Processing Technician I, II and Lead **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Review Batch history records prior to being submitted for quality ... interface between operations and the Quality control team. The Batch Record review may also... Lead on: + Individual Tissue Processing Technician batch record performance + Recommend disciplinary action… more
- Abbott (Altavista, VA)
- … batch non-conformances or potential non-conformances and initiate appropriate actions. + Review batch records for accuracy, completeness and compliance ... for data collection, ie Engineering and DQA + Expedite batch review and release when asked by...business needs dictate. Back up for Batch Records auditors + Document and occasionally lead … more
- AbbVie (North Chicago, IL)
- …The Batch Record Reviewer II audits Manufacturing and/or Packaging batch records , performs transactions in inventory systems to release batches for ... Operations in the processing of a material or product batch *Ensure any batch record ...external customers, and regulatory agencies Ensure batch records are retained and filed securely * Lead … more
- Actalent (Foster City, CA)
- Description: Executes batch record review Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in ... accepted practice and evaluates impact assessment as required. Performs Batch Record review and ATS...in Gvault; may also conduct or serve as a lead /coordinator of investigations and corrective and preventive action (CAPA)… 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
- 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
- Lilly (Indianapolis, IN)
- …+ Participate on Joint Process Teams + Originate and investigate deviations associated with batch records and other DPEM activities. + Work with Lilly support ... + Provide assistance and guidance in Standard Operating Procedure revisions, Master Batch Record revisions, Master Packaging Order revisions and Process… 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… more
- Teva Pharmaceuticals (Salt Lake City, UT)
- …coordination of the review and revision of controlled documents (master batch records , procedures, specifications, test methods and forms) to ensure ... Lead Documentation Specialist - SLC East Date: Apr...Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions. + Responsible for performing… 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
- United Therapeutics (Eden Prairie, MN)
- …Records (MBRs), and Test Methods (TMs). Reports errors in a timely and appropriate manner. + Batch Record Review : Perform batch record review . ... to ensuring finished product is manufactured to approved manufacturing batch records and processes. + Manufacturing Floor...Coordinate completion of batch record review in a timely manner to support clinical product… more
- Pfizer (Groton, CT)
- …(immediate release tablets, modified release tablets, microspheres, capsules, etc.) + Author/ review GMP documentation, including batch records , ... **What You Will Achieve** As a Sr. Associate Drug Product Manufacturing (DPM) Lead within Drug Product Supply (DPS) in Groton, CT, the successful candidate will… more
- Amgen (Holly Springs, NC)
- …most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional ... to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class...be a carbon-neutral company by 2027. **Senior Engineer (Mechanical Lead )** **Live** **What you will do** Let's do this!… more
- Actalent (Brownsburg, IN)
- …the team. 6) Skills: + Aseptic, Quality Assurance, Sterility, Process improvement, Batch Record , cGMP, Cyclotron, Particle Accelerator, Sample Prep, Clean Room, ... nuclear medicine, isolator, sterile environment, sterile manufacturing + CAPA, Deviation, SOP Review , Document Review , Technical Writing, Batch Release,… more
- Verista (Devens, MA)
- … Lead Automation Engineer Responsibilities: + Convert our Single Use Facility (SUF) from Paper Batch Record to electronic batch record using MES 3.0. ... LSCC to MES 3.0 as part of MES NextGen project. + Author, edit, and review CSV life cycle documentation (VP, RA, RCA, TM, VSR) and system specifications (URS, FRS,… more
- Regeneron Pharmaceuticals (East Greenbush, 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
- 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
- ManpowerGroup (Bloomington, MN)
- …6.Calculate internal short-term disability compensation programs. 7.Oversee the direct preparation and review of a variety of files, payroll records and reports ... **Job Title: Lead Payroll Specialist** **Location: Bloomington, MN (Hybrid work...company's finance department to manage all aspects of time records and bi-weekly and semi-monthly payrolls. Key Result Areas:… more
- The City of Houston (Houston, TX)
- IT Lead - Applications (SAP/ ERP FICO Team ...ensure seamless operations of the City's core systems of record (SOR) for Finance, HR and other solutions. As ... Lead ) Print (https://www.governmentjobs.com/careers/houston/jobs/newprint/4438935) Apply IT Lead - Applications (SAP/ ERP FICO Team Lead ) Salary $86,164.00… more