- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Batch Record Reviewer I **Location:** Harmans, Maryland **Company:** Catalent Inc. **About Us:** Catalent, Inc. is a leading global contract ... other viral vector-based therapies and vaccines. **Position Overview:** The Batch Record Reviewer I is...labels, SMPs, and product specific documents. + Independently executes batch record review for completeness,… more
- Catalent Pharma Solutions (Harmans, MD)
- …packaging, and release of cell and gene therapy products. + Independently executes batch record review for completeness, accuracy and cGMP compliance. ... in accordance with good documentation practices (GDP), including but not limited to: executed batch records , master batch records , product labels, SMPs,… more
- Catalent Pharma Solutions (Harmans, MD)
- …packaging, and release of cell and gene therapy products. + Independently executes batch record review for completeness, accuracy and cGMP compliance. ... in accordance with good documentation practices (GDP), including but not limited to executed batch records , master batch records , product labels, SMPs,… more
- Catalent Pharma Solutions (Harmans, MD)
- …a team within the Batch Disposition group (Quality Assurance) and ensuring timely batch record review and lot disposition to release product within ... **Job Title:** Senior Manager, QA Batch Disposition **Location:** Harmans, Maryland **Company:** Catalent Inc....Responsibilities:** + Manages the day-to-day operations of the QA Batch Disposition team. + Ensure staff are fully trained… 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)
- …with applicable procedures and batch records , providing real time review of manufacturing batch record documentation and logbooks, and working ... 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… more
- Catalent Pharma Solutions (Harmans, MD)
- …solutions + Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's + Compile deviations as required ... floor. + 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)
- …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 (Baltimore, MD)
- …Role** + Perform processing steps and manufacturing support activities, monitoring processes against batch records . + Complete and review GMP documentation ... room/aseptic environment operations + Working knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's,… more
- Catalent Pharma Solutions (Baltimore, MD)
- …room/aseptic environment operations + Working knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... activities, etc. + Completes and reviews GMP documentation and batch records accurately and promptly. + Demonstrates...Join Catalent** + Defined career path and annual performance review and feedback process + Potential for career growth… more