QA Batch Review Specialist
About The Position
Woodstock Sterile Solutions is seeking a Batch Review Specialist to perform comprehensive quality review of batch records and supporting documentation. The role ensures records are complete, accurate, and compliant with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), company procedures, specifications, and applicable regulatory requirements. The specialist prioritizes records based on cycle time, customer expectations, and business needs; tracks corrections, exception reports, and required testing; and supports timely batch disposition and release decisions. The role works closely with Manufacturing, Quality, Supply Chain, and clients to resolve documentation and process issues and support product release for distribution.
Requirements
- Associate of Science degree, a two-year technical degree, or relevant experience in manufacturing, Quality Assurance, or a Quality Control laboratory.
- Four years of directly applicable experience in an FDA-regulated industry, such as pharmaceutical, medical device, or food manufacturing, or an equivalent combination of education and experience in production, Quality Assurance, or Quality Control.
- Excellent documentation skills and strong written and verbal communication.
- Strong problem-solving and analytical skills, with the ability to drive work to completion and results.
- Organized and detail-oriented, with the ability to manage multiple tasks, work under pressure, and prioritize workload.
- Ability to work effectively with people across roles, functions, and departments.
- Ability to interpret instructions provided in written, oral, diagram, or schedule form.
- Ability to work independently on projects and routine activities and review reports and records for accuracy and logical consistency.
- Familiarity with cGMP and safe work practices.
- Ability to read, write, and speak clear English.
Nice To Haves
- Bachelor of Science degree.
- Proficiency with common business software, such as word processing, spreadsheets, and database applications.
Responsibilities
- Review batch documentation and in-process testing completed by Manufacturing personnel for completeness, accuracy, and compliance.
- Compile complete batch records by collecting documentation from multiple sources, including production and laboratory records.
- Prioritize batch records for review and maintain current status, including corrections, exception reports, and testing required for release.
- Perform final quality approval and release product for shipment when requirements are met; reject product lots when specifications or release requirements are not met, as appropriate.
- Ensure batch record reviews and releases are properly completed and documented; identify and drive resolution of documentation or batch record issues to support timely release.
- Coordinate with Supply Chain, QAPM, and clients regarding Certificates of Analysis (COAs) needed for batch record release; generate Certificates of Conformity as required.
- Communicate with management, associates, and external clients about batch record questions, issues, and concerns; participate in client calls to provide release and batch-record updates.
- Maintain data integrity and comply with company SOPs, specifications, cGMP, GDP, and applicable FDA, EU, JP, cGxP, and OSR requirements; maintain current knowledge of relevant requirements and serve as a plant resource.
- Perform real-time, online review and audit of the manufacturing process during production, as needed.
- Support regulatory, customer, and internal audits through document review and retrieval, audit participation, and preparation or review of audit tasks.
- Identify deviations and non-compliances and report them to Manufacturing and/or MQA as appropriate; actively participate in resolving documentation and process issues.
- Review and approve minor investigations, non-conformances, and deviations in MasterControl, as assigned.
- Support regulatory investigation teams, including investigations involving Field Alert Reports or product withdrawals, through document review and retrieval.
- Maintain the effectiveness of applicable Quality System components; identify, evaluate, and manage product-quality risks and communicate relevant risk policies and processes.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
