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
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
· Our recruiting process includes multiple in person and/or video interviews and assessments.
· If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
· We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
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Skills Required
- Bachelor’s degree in Life Science, Statistics, or a related field, or equivalent years of experience
- At least 3 years of experience in QA, regulatory compliance, or pharmaceutical operations
- Experience working in a cGMP manufacturing environment
- Experience developing quality system requirements for pharmaceutical drug production and laboratory facilities
- Experience with validation for pharmaceutical manufacturing facilities
- Experience reviewing and releasing cGMP production batches
- Knowledge of U.S. regulations and ability to interpret and apply regulatory requirements
- General knowledge of statistical concepts
- Six Sigma Green Belt certification
What We Do
American Regent, Inc., a Daiichi Sankyo Group Company, is a leading manufacturer of generic and branded specialty sterile injectable products. Dedicated to improving human and animal health, the company develops, manufactures, and supplies high-quality injectables for healthcare providers, clinics, and hospitals across the United States and Canada. Their expansive portfolio includes a strong focus on IV iron therapy and other critical specialty injectable medications.
