QA Technical Services Specialist II

Nature and Scope

The QA Technical Services Specialist II (QATSS) will provide a technical and quality compliance audit and review according to existing procedures for cGMP documentation, including, but not limited to, analytical data from Quality Control and Research and Development, Validation Reports for methods, processes, equipment (both laboratory and production), and computers. The QATSS will assist in various QA project teams to support the Quality Systems or Quality Operations groups. The level II 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.

• Review laboratory testing data, various validation/verification documentation, and cGMP qualifying reports (including protocols, protocol reports, Validation Master Plans, Site Master Files, media fills, HEPA certification, maintenance and metrology documentation and change control justifications) to confirm the accuracy and completeness according to cGMPs.
• 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.
• Work closely and effectively collaborate with multiple functions (R&D, Operations, Quality Systems, Validation, Engineering, and/or Production, etc.) to ensure qualification or re-qualification expectations are met.
• Conduct Quality review of Maintenance Work Orders (BMRAM)
• 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.
• Represent quality assurance activities on cross functional teams. Set a standard for collaboration for the delivery of project commitments and customer satisfaction.
• 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.
• Serve as a resource on regulatory cGxP topics.
• Position has responsibilities at multiple locations in central Ohio.
• 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, Liberal Arts or related field required.
• Minimum of five years pharmaceutical experience in QA, Regulatory Compliance, cGMP Compliance Auditing, or related cGMP activities.
• 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, LIMS, 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
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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