QA Compliance Program Specialist II

Nature and Scope

Reporting to the QA Compliance Program Manager, the Compliance Program Specialist II 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

Nothing 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 executing and maintaining 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 executing and maintaining 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 executing and maintaining Customer Complaints Program in Ohio including metric reporting. Works with functional areas to investigate and ensure timely closure of Customer Complaints.
• Responsible for executing and maintaining Gap Assessment program, ensuring procedural compliance and alignment with regulatory (domestic and foreign) compendia, and corporate requirements.
• Responsible for executing and maintaining inspection readiness program including participation in 'tactical room' for regulatory and customer audits.
• Continually collect and maintain presentation of Quality Systems reports/metrics to Senior Management at defined frequencies.
• Participate in Continuous improvement portfolio activities as it relates to Compliance. This may involve cross functionality of areas from QA, QC, OPS, and may require application of statistical concepts and methodologies.
• 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.

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

• Minimum of 3 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 established expertise in interpreting and applying to organization is required.
• General knowledge of overall statistical concepts and Six Sigma Green Belt 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/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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