QA Compliance Program Specialist III

American Regent, Inc.; New Albany (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

American Regent, Inc. in Ohio seeks a QA Compliance Specialist III to lead compliance, CAPA, internal audits and regulatory readiness across sites in Ohio.

You will collaborate with QA, QC, OPS and facilities to investigate, verify CAPA effectiveness, maintain customer complaints, and drive ongoing quality improvements under cGMP. Reporting to the QA Compliance Program Supervisor, the role demands strong analytical skills, mentoring ability, and readiness for regulatory inspections.

Qualifications

• Bachelor's in Life Science or related field or equivalent experience.
• Minimum 5 years in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP environment.
• Experience developing quality system requirements for cGMP compliance and validation; review and release of cGMP batches.
• Knowledge of US regulations; international regulations preferred; Green Belt Six Sigma preferred.

Responsibilities

• Facilitate, maintain, and improve Internal Audit Program with cross-functional teams.
• Facilitate CAPA system and ensure corrective actions are effective per SOPs and cGMPs.
• Drive development and maintenance of Customer Complaints Program with metric reporting.
• Facilitate Gap Assessment and inspection readiness activities for regulatory and corporate audits.
• Support Field Alert Report program and timely closure of pFARs and FARs.
• Mentor Compliance staff across multiple areas and present quality metrics to Senior Management.

Skills

Regulatory compliance knowledge

Statistical concepts

Six Sigma Green Belt (preferred)

Education

Bachelor's in Life Science, Statistics, related field or equivalent years of experience

Job description

Nature and Scope

Reporting to the QA Compliance Program Supervisor, the QA Compliance Specialist III focuses on facilitating Compliance and CAPA System activities at American Regent. This is a multi-disciplinary role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at all American Regent Sites in Ohio.

Essential Duties and Responsibilities

• Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.


• Responsible for facilitating, maintaining, and improving Internal Audit Program. Work with Functional Area Management and cross-functional teams to ensure procedural compliance and alignment with internal, regulatory, and corporate requirements.


• Responsible for facilitating, maintaining, and improving Compliance Corrective Action and Preventive Action (CAPA) System. Work with owners and cross-functional teams to ensure appropriate Corrective Action Plans are implemented and verified for effectiveness in accordance with company SOPs, policies, and cGMPs and escalated when necessary.


• Responsible for driving development and maintenance of Customer Complaints Program in Ohio including metric reporting. Works with functional areas to investigate and ensure timely closure of Customer Complaints.


• Responsible for facilitating, maintaining, and improving Gap Assessment program, ensuring procedural compliance and alignment with regulatory (domestic and foreign) compendia, and corporate requirements.


• Responsible for facilitating, maintaining, and improving inspection readiness program including participation in 'tactical room' for regulatory and customer audits.


• Responsible for facilitating and supporting Field Alert Report Program in Ohio including metric reporting. Works with functional areas to investigate and ensure timely closure of potential Field Alert Reports (pFARs) and FARs.


• Responsible for facilitating and supporting all follow-up actions related to customer audits, corporate audits, and regulatory inspection, and confirms appropriateness and measures effectiveness of associated CAPA.


• Responsible for continually improving, maintaining, and presenting Quality Systems reports/metrics to Senior Management.


• Responsible for facilitating and supporting the Risk Management program.


• Responsible for facilitating and supporting Continuous improvement portfolio activities as it relates to Compliance. This may involve cross functionality of areas from QA, QC, OPS, and may require statistical concepts and methodologies.


• Responsible for mentoring Compliance Staff across multiple areas.


• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• Bachelors in Life Science, Statistics, related field, or equivalent years of experience required.


• Minimum of 5 years of work experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment is required.


• Experience across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facilities; review and release of cGMP production batches.


• Knowledge of US regulations and experience in interpreting and applying to organization is required.


• Knowledge of international regulations and experience in interpreting and applying to organization is preferred.


• General knowledge of overall statistical concepts and Green Belt Six Sigma certification is preferred.

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/fmaine.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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