Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

Responsibilities:

• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices
• Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance
• Act as first responder for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
• Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.
• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Write, revise and approve GMP documentation as necessary
• Works cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner
• Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.

Qualification Requirements:• Minimum of a B.S. in a Life Sciences discipline
• 5 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry and 2 years’ experience in Quality Assurance/Quality Control 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
• Exposure to Lean Operational Excellence highly desirable
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.