Catalent Pharma Solutions Compliance Specialist in St. Petersburg, Florida

Job Description

The Compliance Specialist reports to the Manager, QA.

St. Petersburg is our primary softgel 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.

The Compliance Specialist will facilitate and provide oversight for Supplier Audits and Certification programs and will facilitate and provide support for regulatory inspections, customer audits, internal audit program. The Compliance Specialist will provide oversight to assure timely responses to all audits/inspections and commitments.

If you would like to be part of a global drug development and delivery leader that puts our patient needs, then this role might be for you!

The Role

  • Facilitate and provide support for on-site Customer and Regulatory audit/inspections

  • Ensure effective communication and dissemination of commitments via TrackWise and other means

  • Assist in authoring/compiling on-demand, monthly, quarterly and annual summaries and metrics associated with compliance activities

  • Assist as compliance SME for internal SOPs and serve as Quality and Regulatory approver for site SOPs

  • Liaise with Customers and Suppliers to agree on commitments and to report status as needed

    The Candidate

  • BS in Science or related degree required

  • At least 3-5 years of pharmaceutical industry experience directly related to QA/Regulatory Compliance

  • At least 3-5 years’ experience auditing pharmaceutical and pharmaceutical excipient manufacturing operations

  • Experience performing investigations and root cause analysis a must

  • Experience preparing audit plans, audit reports, audit responses a plus; Auditor certification and/or RAC certification a plus

Position Benefits

  • Cross functional exposure to other areas of Operations

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

We will identify candidates based on the following Catalent Competencies:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Grow with us. Be challenged. Make a personal impact.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.