Sr. Compliance Specialist
Position Summary
St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Sr. Compliance Specialist will facilitate regulatory inspections, customer audits, internal audit program, and Certification programs. Provide oversight to assure timely responses to all audits/inspections and commitments thereof. The Sr. Compliance Specialist will provide cross-training to ensure the Internal Assessment and Certification programs remain compliant with site procedures as well as the CFR requirements. In support of this activity, this position will review site audit histories of all types of ensure audit readiness and compliance with multiple regulatory agencies and guidelines from a global perspective.
The Role
Participate in Supplier Audits and Certification programs, including the following: auditing suppliers through surveys and on-site, preparing audit reports, audit Scheduling and Coordination.
Facilitate and participate in Internal Audits: perform and facilitate internal audits as indicated in scheduler, mentor and train volunteer assessors.
Facilitate and host on-site Customer and Regulatory audit/inspections.
Prepare site audit responses by collaborating with site SMEs and department heads and oversee timely completion of commitments thereof Ensure effective communication and dissemination of commitments via TrackWise and other means.
Track, trend, report, and provide follow-up, and drive closure of audit/inspection commitments.
Facilitate approval of audit/inspection commitments via TrackWise and other means.
Author/compile on-demand, monthly, quarterly and annual summaries and metrics associated with compliance activities.
Ensure the adherence to the standards of quality ruled by current worldwide Good Manufacturing Practices, US DEA regulations, and the Company’s Quality Policies and site Standard Operating Procedures.
Other duties as assigned.
The Candidate
Bachelor of Science Degree required, preferably in Science or related field (Chemistry, Microbiology or Biology).
At least 3 years of pharmaceutical industry experience directly related to QA/Regulatory Compliance.
At least 3 years of experience auditing pharmaceutical and pharmaceutical excipient manufacturing operations.
Experience preparing audit plans, audit reports, audit responses.
Auditor certification and/or RAC certification a plus.
Working knowledge of cGMPs and FDA/DEA/State of Florida regulations.
Knowledge of TrackWise software preferred.
Ability to work effectively under pressure to meet deadlines. Ability to travel. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and frequent use of computer monitor.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Process
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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