QA Technical Services Specialist I

Nature and Scope

The QA Technical Services Specialist (QATSS) will provide technical and quality compliance review in one or more of the following areas; 1) Engineering and Maintenance activities, including but not limited to the calibration, maintenance and preventive maintenance system (Blue Mountain - "BMRAM"), 2) pre-production cGMP documentation, including, but not limited to, analytical data from Quality Control and Research and Development, 3) Validation Reports for methods, processes, equipment (both laboratory and production), and 4) computer qualification reports when requested by GXP. The QATSS will assist in various QA project teams to support the Quality Assurance Program Manager to effectively manage and coordinate the activities of the group.

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 Engineering and Maintenance activities, including but not limited to the calibration, maintenance and preventive maintenance system (BMRAM) records.
• Review GMP pre-production cGMP documentation, that includes, but is not limited to, analytical data from Quality Control and Research and Development.
• Review Validation Reports for methods, processes, equipment (laboratory and production)
• Review Computer qualification reports as requested by GXP.
• Write and revise SOPs and other cGMP documentation.
• Pro-Actively identify, manage, and communicate potential quality risks and ensure the appropriate follow up actions for resolution.
• Support external audits of suppliers and contract facilities, as well as, internal quality systems and on-site audits performed by regulatory agencies and external providers.
• Provide support for the completion of Quality Systems exception documents and customer complaint investigations.
• Ensure all work is performed and documented in accordance with existing Company Policies and procedures, as well as cGMP and health and safety requirements.
• Assist in quality assurance activities on cross functional teams. Set a standard for collaboration for the delivery of project commitments and customer satisfaction.
• 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.

• Bachelor's Degree in Life Sciences, Chemistry, Pharmaceutical Science or related field required.

• Minimum 3 years pharmaceutical experience in QA, Regulatory Compliance, cGMP Compliance, Auditing or related cGMP activities.

• Knowledge of cGMP regulations, cGxP, and associated Quality Systems activities.
• Strong attention to detail.
• Excellent organizational, interpersonal, and communication skills (oral & 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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