- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to pharmaceutical Operations and perform acceptance quality limit (AQL) inspectionReconcile and review executed batch production records for batch ... information is accurate and provide approval after packaging activitiesReview batch records during active manufacturing Perform routine manufacturing… more
- Catalent (Philadelphia, PA)
- …and activities associated with batch record documentation, reviewing and approving batch records , and releasing batch records and finished ... every patient, consumer, and Catalent employee. The Role: Responsible for ensuring batch record documentation aligns with activities performed and is compliant… more
- Merck & Co. (Durham, NC)
- …A Minimum of 3 years in a quality function. Previous investigation and CAPA experience, Batch Record Review , Validation IQ, OQ, PQ, Change Control. Product, ... Review and approve BOM changes and Master Batch Records . Review and approve...site or organization, with Friday designated as a remote-working day , unless business critical tasks require an on-site presence.… more
- Catalent (Manassas, VA)
- …materials necessary to meet production goals and requirements. Verifies and keeps records on incoming and outgoing product & material movements, accurately. Process ... soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …includes creation of master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance ... activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to shipAssists...preferred TravelAbility to travel up to 10% Overnight / single- day travel will be required to go to outsourcing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferred. Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols. Experience with ... Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferred. Experience reviewing/auditing documentation including but not limited to: Batch Records , SOPs, Work Instructions, Validation protocols. Proficient ... Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards, industry standards, and global regulations. Provide Quality Oversight for batch records , change controls, SOPs, non-conformances, risk assessments, ... Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… 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 ... + Monday-Friday, 2nd Shift In this role, a typical day might include the following: + Representing Quality Assurance...guidance on QA procedures and polices as well as review of documents for both internal and external transfers… 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
- J&J Family of Companies (Raritan, NJ)
- …of health for humanity._ In this position you will lead quality oversight of the batch record review and release process for products manufactured by ... body and environment within reach of everyone, everywhere. Every day , our more than 130,000 employees across the world...Proven experience working with external partners. + Experience with batch record review and release… more
- City and County of San Francisco (San Francisco, CA)
- Hybrid Workplace: Our workplace has a hybrid/flexible weekly schedule, where colleagues work 1 day onsite (in the San Francisco office) and 4 days from home, subject ... to periodic review and approval. Controller's Office The Controller is the...2017. This is now the central system of financial record and budgetary control for the City and County… 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 ... cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: + Representing Quality Assurance in support of… more
- ADM (Columbus, NE)
- …inter-org transfers. + Provide copy monthly to plant personnel and address past dues. + Maintain batch review report. + Print batch review report weekly, ... DUTIES** + Answer phones and greet incoming visitors. + Review and enter all receiving paperwork into Oracle daily....oracle daily. + Ship confirm orders daily. + Enter batch sheets from previous day production. +… more
- PCI Pharma Services (Philadelphia, PA)
- …this will contact the appropriate personnel to recalibrate and/or remediate the issue. 4. Review batch record (MPI's) to ensure equipment challenges and ... within acceptable job parameters. 9. Identify proactively gaps in batch records and TER's to mitigate deviations...appropriate personnel to recalibrate and/or remediate the issue. 4. Review batch record (MPI's) to… more
- Kelly Services (Barceloneta, PR)
- …Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records , investigation of deviations, exceptions ... Administration personnel. The batch record review encompasses manufactured batch records ,...solutions to solve the world's most critical challenges. Every day , we match science professionals with dream jobs that… more
- RWJBarnabas Health (Jersey City, NJ)
- …RecordsReq #:0000150909 Category:Clerical / Administrative Support Status:Full-Time Shift: Day Facility:Jersey City Medical Center Department:Medical Records ... working Epic Queues. Maintains chart quality in both the paper and electronic record . Ensures all operative reports and H&Ps are dictated/available within 24 hours… more
- Catalent Pharma Solutions (Morrisville, NC)
- …The Production department executes, completes, and reviews all associated master batch record documentation; creates and reviews standard operating procedures; ... batch manufacturing + Create and revise master batch records including interacting with other departments...as coordinator for operations activities including JD Edwards support, batch record requisition, work order completion, and… more
- HCA Healthcare (San Antonio, TX)
- …when completed. You will prepare all work records needed for the day including prepacking batch logs, census reports, outdate reports and unload reports. ... will accurately perform routine manufacturing and prepackaging maintaining accurate and complete record logs. You will ensure that a pharmacist checks all work. You… more
- Bristol Myers Squibb (Bothell, WA)
- …train and mentor junior team members. **Knowledge & Skills:** + Hands-on experience with batch record review and product disposition."" + Strong computer ... Saturday, Onsite 9 pm - 7:30 am **Responsibilities:** + Review executed batch records to...approval. + Minimum of 1 year of experience with batch record review . **Preferred Requirements:**… more
