- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, ... regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Job ResponsibilitiesCoordinates the issuance of batch records with MBR revisions and change control closures.Coordinates issuance of batch records with QA Holds ... appropriately.Creates the electronic and hardcopy file folders for each batch file.Prepares and prints the batch production...for each batch file.Prepares and prints the batch production record from the master production record file.Checks… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Planner, Batch Logistics as part of the Supply Chain team based in Raritan, NJ. ... Role OverviewThe CAR-T Batch Logistics Planner will be responsible for managing cross-functional...managing cross-functional teams to ensure smooth, timely and compliant batch release operations. The successful individual will help drive… more
- Aequor (Devers, TX)
- …responsibilities include:Ensuring manufacturing compliance with applicable procedures and batch records.Providing real-time review of manufacturing batch ... the floor activities.Ensure manufacturing compliance with applicable procedures and batch records.Perform real-time review of manufacturing batch records.Review… more
- Aequor (Bothell, WA)
- …for GMP compliance to enable lot release, specifically: a. Review executed batch production records and test data to ensure compliance with approved procedures ... expectations b. Review certificates of analysis c. Evaluate discrepancies noted during batch record reviews d. GMP incident/deviation review 2. Apply the principles… more
- Eisai, Inc (Raleigh, NC)
- …policies, procedures, and regulatory requirements. This includes reviewing batch documentation and investigating deviations.Process Management: Assist in managing ... including isolators, automated inspection, Manufacturing Execution Systems and electronic batch release.Competent in analyzing complex products, production, and testing… more
- Merck & Co. (Rahway, NJ)
- …so a good mechanical understanding of process equipment will be required. While most batch production will occur on days, on occasion spray drying runs may require ... this position as it will be based on the shop-floor. Experience with electronic batch records and documentation is a plus.This position is 100% on-site and evening… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for pharmaceutical finishing activitiesFollow/enforce Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including ... reconciliation, traceability, training, and/or accurate and timely completion of finishing batch records and paperworkEnsure self and finishing team members are… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for pharmaceutical finishing activitiesEnforce/follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including ... training, and/or accurate as well as timely completion of finishing batch records and production paperworkConduct employee reviews and provide coaching as… more
- Aequor (Northborough, MA)
- …Good Manufacturing Practices and Safety policies/procedures. Document production activities in batch records, log sheets, attachments and/or electronic Batch ... Records. Maintain sufficient inventory of packaging materials. Follow operational procedures and both written and verbal instructions from the supervisor/Manager. Perform manual packaging on an assembly line. Ability to lift up to 35 lbs. and move heavy… more
- Merck & Co. (Rahway, NJ)
- …control.Experience with state-of-the-art cell culture processes including intensified inoculum/fed- batch and perfusion process development.Background in data science ... Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.Experience with mathematical modeling, theoretical… more
- Merck & Co. (Durham, NC)
- …updates technical and manufacturing documents necessary for change controls, batch records, standard operating procedures, corrective and preventative actions among ... or drug product.Experience with aseptic process simulations (APS), electronic batch records, and/or change controls.Demonstrated ability to work in fast-paced,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP ... and issue GMP logbooks.Responsible for storage and archival of GMP documents and batch related records.Perform tasks in a manner consistent with the safety policies,… more
- Merck & Co. (Durham, NC)
- …up of facility.Author, review, and/or edit operations and technical documentation ( Batch Records, SOPs, Job Aides, training, and engineering documents) to support ... project and future operations.Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel.Actively participate in team meetings HAZOPS, waste walkthroughs, 5S, kaizen events,… more
- Aequor (West Greenwich, RI)
- …and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation. Ensure that ... deviations from established procedures are documented per procedures. Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements. Alert management of quality, compliance,… more
- Aequor (Swiftwater, MN)
- …and global procedures. They support the assembly and review of paper and electronic batch records, on and offsite file storage, support the completion of lot release ... protocols, maintain and utilize databases (MARS Siemens/SAP/iSHIFT/QualiPSO, etc.). Perform other administrative tasks per the direction of management. Bachelor's Degree: 0 - 3 years experience No degree: 3 - 5 years experience more
- Aequor (MA)
- …the timely initiation of GMP manufacturing activities. Perform QA review of Executed Batch Records. Perform QA review of Quality Records, ie Deviations, CAPAs, OOS ... etc., as they occur. Perform QA review and approval on SOPs, forms, WI, and other document types. Provide SAP support for GMID and BOM approval. Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug… more
- Eisai, Inc (Baltimore, MD)
- …and supports the Director, Gliadel OperationsOther duties as assigned such as batch record review and validation support.Ensures CAPAs and other changes related to ... the Metrology program are meaningful and effective.Lead continued successful transition to new computerized system (Blue Mountain)Support PV and commercial productionIdentifies and pursue continuous improvement. Requirements Bachelor's degree or equivalent… more
- Aequor (Bothell, WA)
- …data analysis. Accurate and reliable record keeping including database management, batch records, notebooks, and all pertinent documentation. Data analysis with ... guidance, summarize and present experimental findings in team meetings Assist in documentation where appropriate. Follow Standard Operating Procedures and adhere to all safety and company policies.Technical Skills Exceptional aseptic technique desired… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for pharmaceutical manufacturing activitiesFollow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data ... Integrity and Good Documentation Practices (GDocP) Assist with executing responsibilities associated with preparing for the production of aseptic or terminally sterilized product (compounding, filling, sterilization, palletizing, transfer), and/or accurate and… more
