QA Technical Services Specialist III

American Regent, Inc.; New Albany (OH); Hybrid; USD 95.000 - 125.000; Vollzeit

Zusammenfassung

American Regent, Inc. is seeking a QA Technical Services Specialist III to lead technical reviews and audits for cGMP documentation.

The role collaborates with Validation, Engineering, Production R&D, and Operations to ensure qualification standards are met and regulatory requirements are upheld. You will help manage quality risks, draft and revise SOPs, and support regulatory inspections with minimal supervision.

Qualifikationen

• Five years of pharmaceutical QA or regulatory compliance experience.
• Strong analytical skills and attention to detail.
• Working knowledge of cGMP regulations and related QA systems.
• Willingness to travel domestically.

Aufgaben

• Collaborate with cross-functional teams (Validation, Engineering, Production R&D) to meet qualification/ re-qualification expectations.
• Review GMP documents using Quality Risk Management and guide authors on discrepancies.
• Identify and manage quality risks and ensure follow-up actions.
• Ensure work complies with SOPs, policies, cGMP, and safety requirements.
• Review calibration and maintenance records (BMRAM, etc.) and support inspections.

Kenntnisse

Analytical skills

Attention to detail

Communication skills

GMP knowledge

Travel allowed

Ausbildung

Bachelor's or Master's in Life Sciences

Tools

Asset management software

BMRAM

Document management software

Jobbeschreibung

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/fmlen.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

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.