Batch Record Reviewer (night)
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Apply Now Application ends in 13d 8h 48min
Job Detail
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Offered Salary 0
Job Description
Qualifications
- +4 years’ experience within the biologic, biopharmaceutical, pharmaceutical or regulated industry
- +2 years’ experience in a Quality Assurance/Quality Control or Manufacturing function
- Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- dynamic pace
Benefits
- Defined career path and annual performance review and feedback process
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
- Catalent offers rewarding opportunities to further your career!
Responsibilities
- The Batch Record Reviewer is responsible for providing support to manufacturing for GMP documentation of master/working cell banks, bulk drug substance and finished drug product
- Responsibilities include but are not limited to GMP documentation review and supporting other manufacturing/MTO functions as needed
- In this role, The Batch Record Reviewer is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements
- This is a full-time on-site position, 7:00 pm to 7:00 am
- Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents
- Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product
- Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs
- Independently executes record review for completeness, accuracy and cGMP compliance and compile and report performance metrics for Batch Review and Release
- Contributes to process improvement of records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met
- Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate
- Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities
- Prepare reports right the first time (RFT) reports and keep upper-level management informed of progress as manufacturing reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management
- Performs duties under limited supervision and according to standard operating and manufacturing procedures
- Collaborates within Manufacturing to resolve record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory
- Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
- Perform tasks in a manner consistent with all Catalent policies including safety (EHS), quality systems and cGMP requirements
- Understand risks and delays to batch release and communicate appropriately
- Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs
- Participate in site and corporate quality and process improvement initiatives
- Represent MTO on project teams and represent the Batch Disposition manufacturing perspective as needed
- Interact with stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products
Apply Now
Application ends in 13d 8h 48min