Quality Assurance Specialist Position Available In Jefferson, Alabama

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Quality Assurance Specialist Job Description The Quality Assurance Specialist is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and supporting manufacturing operations through documentation review, product disposition, and real-time quality oversight. This role is crucial in maintaining product integrity and regulatory compliance across production campaigns. Responsibilities Provide support for room clearance activities prior to and during manufacturing operations. Offer on-the-floor and on-call QA support during manufacturing campaigns for PDS Products, PDS Services, and MDS. Issue and reconcile product labels in accordance with GMP requirements. Review production campaign documentation and batch records for completeness and accuracy. Perform final disposition of finished products, raw materials, and fill/finish components. Review cleanroom logbooks and ensure proper documentation practices. Update, review, and approve QMS documentation (SOPs, work instructions, forms, specifications) using the Regulus document control system. Support SAP-related QA activities, including inspection plan reviews. Review data supporting the testing of site utilities (e.g., WFI, steam, nitrogen). Conduct monthly GMP monitoring of laboratories, manufacturing areas, and warehouse facilities. Essential Skills Experience in quality assurance with a focus on GMP and quality control. Knowledge of chemistry and quality management systems. Proficiency in document control and SAP. Interpersonal skills and ability to work in a team-oriented environment. Desire for longevity with the company and ability to articulate reasons for this commitment. GMP experience and regulatory compliance expertise. Additional Skills & Qualifications Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field. Minimum of 2 years of experience in a GMP-regulated QA role within pharmaceutical or biotech manufacturing. Strong knowledge of batch record review, product disposition, and quality systems. Familiarity with SAP and electronic document control systems such as Regulus. Excellent attention to detail, communication, and organizational skills.