Quality Assurance & Regulatory Affairs Compliance Specialist

Quality Assurance & Regulatory Affairs Compliance Specialist

Position Summary
Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell and Vegicaps capsules expand the range of molecules into softgel ideal for challenging fill the Catalent network we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.

The Quality Assurance & Regulatory Affairs Compliance Specialist is responsible for quality and regulatory affairs services at the site level. The Quality Assurance & Regulatory Affairs Compliance Specialist will support the primary coordination of the Change Control processes for the site also including but not limited to Drug Master File (DMF) Updates Health Authority GMP requests processing and investigating customer product complaints preparing annual product reviews and tracking and trending.

Your talents ideas and passion are essential to our mission: to help people live better healthier lives. 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 Role

• Coordinate Track and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.

• Provide initial regulatory impact assessment on all change controls as required.

• Liaise with customers to ensure customer requirements are satisfied.

• Preparation and submission of A/NDA submissions (initial amendments supplements annual reports 15-day Alert Reports); drug master files (initial amendments annual reports); plant/site master files; licenses permits and registrations to meet FDA and State requirements (especially Florida); other submissions as required.

• Prepare and submit all federal state and local permits in a timely manner.

• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations assure root cause analysis and batch impact assessment are adequate and recommend corrective actions to prevent deviation recurrence; ensure on time closure.

• Collaborates with Subject Matter Experts (SME)s management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation following up on issues and a working jointly towards resolution.

• Perform other duties as assigned.

The Candidate

• Bachelors degree in science or related field required (Chemistry Microbiology or Biology) required.

• A minimum of 3 years related experience in the pharmaceutical manufacturing industry required.

• Strong background working with Change Controls and management of change control processes required.

• Prior experience working with investigation writing including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.

• Ability to solve problems with little guidance. Ability to identify the most efficient method to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit stand walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.

Why You Should Join Catalent

• Tuition Reimbursement Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO 8 paid holidays.

• Medical dental and vision benefits effective day one of employment.

• Defined career path and annual performance review and feedback process.

• Diverse inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

• Dynamic fast-paced work environment.

• Positive working environment focusing on continually improving processes to remain innovative.

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

• Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.