Nature and ScopeReporting 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 ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- 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 escalate 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 QualificationsTo 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.
- 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.
