QA Specialist (Batch Record Reviewer)
About The Position
The QA Specialist (Batch Record Reviewer) reviews and releases semi-finished and finished drug products, ensuring adherence to Standard Operating Procedures and current Good Manufacturing Practices. The role includes quarantining and monitoring products on hold, preparing required batch-disposition documentation for international markets, and supporting compliant, timely product release. The specialist reviews batch-related documentation across manufacturing, production, validation, and quality assurance and provides final product-release sign-off. The role requires independent judgment and critical thinking when evaluating batches, evidence, CAPAs, and CAPA effectiveness.
Requirements
- Bachelor’s degree in the sciences or a technical field, or equivalent experience.
- Five years of experience in a quality role or handling and reviewing documentation records.
- Three years of experience in a GMP environment.
- Intermediate Microsoft Word and Microsoft Excel skills.
- Ability to exercise independent judgment and critical thinking.
- Competency utilizing electronic systems such as Maximo and Trackwise for quality checks.
Nice To Haves
- SAP experience.
- Experience in an aseptic manufacturing environment.
- Working knowledge of Quality Assurance systems, cGMPs, ISO 13485, CMDRs, and EMEA regulations.
Responsibilities
- Perform Quality Assurance review and release of semi-finished products, validation, media, and final products.
- Review batch records to support the product release schedule while ensuring regulatory compliance, customer satisfaction, and product delivery.
- Quarantine and monitor products with an “on hold” status prior to disposition.
- Prepare and provide required batch-disposition documentation to international markets to support current Good Manufacturing Practices compliance.
- Identify and resolve batch-record discrepancies to prevent regulatory impact.
- Assist department supervisors in maintaining dispositioned batch records for efficient, secure storage and retrieval.
- Perform final product disposition and follow global procedures and SOPs for release in SAP.
- Use independent judgment when assessing each batch based on available evidence, including CAPAs and their effectiveness.
- Perform Quality Assurance checks of batch-related documents for manufacturing, production, validation, and quality assurance departments.
- Provide final sign-off for products being released to market.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
