732-661-0400

QA Supervisor

  • Location: Dayton, OH area
  • Type: Direct Hire
  • Job #37889
  • Salary: $120.00

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

Responsibilities
• 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

Requirements
• 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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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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