Quality Assurance Specialist

Description:

Review executed batch production and packaging records for accuracy, completeness, and cGMP compliance. Verify calculations, yields, and data entries against established specifications and SOPs. Identify and document errors, discrepancies, and deviations in batch records; escalate issues to QA management as appropriate. Support investigations into documentation errors, OOS results, deviations, and CAPAs as required. Collaborate with Manufacturing, Quality Control, and Supply Chain to resolve batch record-related issues. Assist in maintaining audit readiness by ensuring records are compliant, organized, and complete. Contribute to continuous improvement of documentation practices, workflows, and review processes. Support preparation for regulatory inspections, client audits, and internal audits. Participate in drafting, revising, and reviewing SOPs, work instructions, and QA documentation related to batch record review. Ensure adherence to data integrity and ALCOA+ principles across all documentation practices. All other activities commensurate with the role, as required

Requirements:

Computer savvy Proficient in Microsoft Excel Strong communication skill