- Integra LifeSciences (Columbia, MD)
- …record reviewer will be the interface between operations and the Quality control team. The Batch Record review may also perform the tasks required as a ... I, II and Lead **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Review Batch history records prior...Technician II + Make suggestions that would improve the batch record review process or… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Batch Record Reviewer** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. ... AAV and other viral vector-based therapies and vaccines._ The ** Batch Record Reviewer** is responsible for providing...documentation practices (GDP), including but not limited to: executed batch records , master batch … more
- Catalent Pharma Solutions (Hanover, MD)
- …testing, packaging, and release of cell and gene therapy products + Independently executes batch record review for completeness, accuracy and cGMP compliance ... documentation practices (GDP), including but not limited to: executed batch records , master batch ...and SOPs + Compile and report performance metrics for Batch Review and Release + Contributes to… more
- Catalent Pharma Solutions (Hanover, MD)
- …support batch disposition + Review of terminated, discontinued and rejected batch records and other GMP documents as applicable. + Responsible for the ... QA Operations support on maintaining, filing and scanning of batch records and supporting documentation. This role...responsible for the timely data entry and maintenance of batch review life cycle tracker and visual… more
- Catalent Pharma Solutions (Harmans, MD)
- …Quality Assurance Batch Release provides strategic oversight and leadership to QA Batch Record Review and Release supporting clinical and commercial drug ... for programs, processes and team members of the department, related to batch record review and disposition supporting clinical and commercial drug substance… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream...Ensure batches adhere to established Quality standards. + GMP batch review and close-out with Quality Assurance… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... procedures for upstream, downstream, and solution preparation manufacturing using SOP's and batch records . Operating production equipment in support of all drug… more
- Catalent Pharma Solutions (Harmans, MD)
- …for upstream manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream processing that may ... development groups to assist with tech-transfer, scale-up, and translation activities. + GMP batch review and close-out with Quality Assurance group. + Conduct… more
- Catalent Pharma Solutions (Harmans, MD)
- …with applicable procedures and batch records , providing real time review of manufacturing batch record documentation and logbooks, and working ... relevant procedures; monitor, participate and oversee the real time batch record review process, including...floor. * Ensure manufacturing compliance with applicable procedures and batch records ; review manufacturing shop… more
- Catalent Pharma Solutions (Harmans, MD)
- …solutions; generates or revises GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's; compile deviations as required ... frame + Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good… more
- Catalent Pharma Solutions (Harmans, MD)
- …Write and/or approve manufacturing documentation, including validation protocols, SOPs, and master batch records . + Review client processes for compatibility ... as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's,… more
- Catalent Pharma Solutions (Harmans, MD)
- …The **Specialist II, MTO** will provide support to Manufacturing Associates to meet batch record review /disposition schedule to adhere to lot release ... and revising GMP documents such as SOPs and Manufacturing batch records . **This is a full-time on-site...**osition Benefits:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture +… more
- Koniag Government Services (Baltimore, MD)
- …Cyberfusion, Managed File Transfer, connect: Direct) for failed or hung files. + Review batch job documentation for outdated information routinely and when ... & Duties may include, but are not limited to:** + Monitor batch production scheduling environments via multi-distributed platforms. + Process batch … more
- Catalent Pharma Solutions (Harmans, MD)
- …implementation. Manage the OTL for analytical method implementation and support SMPs and Batch records implementation review . Catalent is a global, ... stability studies. + Review and approve client sampling plans. + Review and approve batch records . Ensure sample testing schedule is accurate. + Develop… more
- Catalent Pharma Solutions (Harmans, MD)
- …well as routine production tasks + Excellent documentation skills including comprehension, review & establishing Batch Production Records , SOP's, deviation ... safety of every patient, consumer, and Catalent employee.** **The Role:** + Completes Batch Production Records under cGMP, and documents in detail through the… more
- Catalent Pharma Solutions (Harmans, MD)
- …) + Works with clients during initial and subsequent manufacturing campaigns + Conducts review of master batch records during Technical Transfer for client ... include tracking and reviewing technology transfer documents, specifications, master batch records , change requests, deviations and failure investigations… more
- Catalent Pharma Solutions (Harmans, MD)
- …Technician I** will be expected to support the execution of GMP manufacturing batch records and ensures necessary supply levels in the manufacturing areas. ... patient, consumer, and Catalent employee.** **The Role** + Execution of manufacturing batch records , SMP's, work instructions, and/or SOPs, with minimal… more
- Catalent Pharma Solutions (Harmans, MD)
- …Authors and reviews technical reports, process tech transfer summary reports, master batch records , product and equipment specifications, and protocols in ... director will be responsible for supporting the preparation and review of documentation, compiling and analyzing of process data,...CAPAs, and change controls + Ability to write SOPs, batch production records and reports independently. Strong… more
- Rise Baking Company (York, PA)
- …into food safety issues, foreign material findings, and customer complaints + Review production records for completion and compliance with good documentation ... as required; follow up and complete disposition when determined + Verify batch formulas and product labels ensuring activities are complete and meet specifications… more
- Catalent Pharma Solutions (Harmans, MD)
- …Management Systems. + Experience with review of CAPA reports, Master Batch Records , SOPs, change control, validation protocols and reports, QA agreements, ... current Good Documentation Practices (cGDP). + Experience in data review , 21 CFR Part 11 instrumentation compliance. + Knowledgeable...ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints. +… more