QA Supervisor

Quality Assurance Supervisor

Astrix has an outstanding opportunity for an experienced Quality Assurance Supervisor based onsite at our clients just outside Dayton, OH. This is a direct hire opportunity offering great benefits!

Quality Assurance Supervisor

• Supervise the day-to-day operations of the GMP QA department
• Develop and monitor GMP compliant quality systems
• Supervise GMP QA staff members
• Serve as QA Manager designee in his/her absence
• Assist in investigation of out of specification (OOS) results, deviations and nonconformance
• Approve CAPAs (Corrective and Preventive Action documents) and deviation investigations
• Conduct internal compliance audits. Make procedural recommendations to ensure compliance
• Participate in and/or conduct external GMP compliance audits (e.g. suppliers, contract labs)
• Function as a liaison and a quality subject matter expert with notified bodies and external regulatory
agencies such as the FDA
• Compose, review, revise and approve GMP related documents to include, but not limited to: SOPs
(Standard Operating Procedures), protocols, validations, deviations, and system documentation
• Function as Project Manager for various GMP products. This may include the development and oversight
of production plans, resource allocation and generation of timelines. Monitor project progress, ensure
timely completion
• Support site Data Integrity programs
• Author annual product reviews (APRs) for APIs and related products
• Provide quality guidance and consultation to direct reports and management personnel to ensure that
the company is GMP compliant
• Create and execute skill development plans for QA staff members
• Supports development of ISO9001 for non-GMP products
• Perform product release and Certificate of Analysis (COA) review
• Develop and conduct internal GMP training
• Performs data analysis to identify continuous improvement opportunities
• Perform any related work as required

• Bachelor’s Degree in Chemistry or related field of study preferred; equivalent applicable industry
experience may be substituted for the degree requirement
• Minimum of 8 years of experience required with quality systems, GMP regulatory compliance, methods,
and procedures preferably in a pharmaceutical environment
• Minimum of 3 years’ experience required supervising others
• Knowledge and/or experience with ISO 9001, 21 CFR 212 and/or ICH Q7 is preferred
• Excellent interpersonal, verbal, and written communication skills are required
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
• Ability to work independently and in a team environment
• Work is performed primarily in an administrative office environment; however, some work is performed
in an industrial plant environment

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