Nature and Scope

The QA Technical Services Specialist III (QATSS) will provide a technical and quality compliance review and audit according to existing procedures for cGMP documentation, including, but not limited to, validation of critical equipment, utilities and facilities, analytical data from Quality Control and Research and Development, Validation Reports for methods, processes, equipment (both laboratory and production), and computers. The QATSS III will assist in various QA project teams to support the Quality Assurance Manager to effectively manage and coordinate the activities of the group. The level III position requires an individual to perform tasks autonomously with anticipated lead roles for the detailed responsibilities below. There is minimal direct supervision.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Work closely and effectively collaborate with multi -functional teams such as Validation, Engineering, Production R&D, Operations, Quality Systems, etc. and to ensure qualification / re-qualification expectations are met.
• During review of GMP documents, utilizes Quality Risk Management to identify, review and approve any potential impact to process, product, or equipment and provides guidance to authors for completion of discrepancies or deviations.
• Pro-Actively identify, manage, and communicate potential quality risks and ensure the appropriate follow up actions for resolution.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
• Review Engineering and Maintenance activities, including but not limited to the calibration, maintenance, and preventive maintenance system (BMRAM) records.
• Perform duties independently with minimal supervision.
• Support regulatory inspections and on-site cGMP audits performed by external providers.
• Write and revise SOP’s and other cGMP documentation.
• Able to implement regulatory documents and apply them to non-routine issues.
• Serve as a resource on regulatory cGMP topics.
• Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements, providing guidance to plant personnel with documentation inquiries, corrections, and investigations.
• Able to conduct investigations and continuous quality improvement initiatives (such as CAPAs) with minimal supervision. Able to generate reports that describe these activities.
• Position has responsibilities at multiple locations in central Ohio.
• Partner with other departments to implement timely procedural changes and resolve compliance issues.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

B.S. or M.S. degree in Life Sciences, Chemistry, Pharmaceutical Science or related field required.

Minimum of five years pharmaceutical experience in QA, Regulatory Compliance, cGMP Compliance Auditing, or related cGMP activities.

Strong analytical skills, attention to detail and adherence to all procedures and company policies.

Working knowledge of cGMP regulations, cGxP and associated Quality Systems activities.

Able to travel domestically as needed.

Strong attention to detail. Excellent organizational, interpersonal and communication skills (oral and written). PC Skills required.

Working knowledge of industry specific computer applications (i.e. asset management software, BMRAM, document management software, etc.).

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

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• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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