QA/RA 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 QA/RA Compliance Specialist will facilitate the businesses of Catalent Pharma Solutions – Pharma Softgel – St. Petersburg, FL and that of its customers. This is done by ensuring that Catalent operates within governmental regulations for its pharmaceutical chemistry, manufacturing and controls areas, and by providing appropriate chemical/regulatory knowledge and support. The QA/RA Compliance Specialist will interact directly with manufacturing, engineering, product development, technical services, validation, etc personnel and is responsible for the quality/regulatory feedback loop to those impacted areas. Also, this position will involve preparing filings to support site registrations and permits as well as regulatory submissions to the FDA, FL DBPR, and other worldwide agencies as needed to support Customer filings under the direction of the team Group lead and manager.
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)
Interact with Customers and gather information as needed to support registration activities.
Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader.
Assist in regulatory/health authority audits collecting information as requested.
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.
All other duties as assigned.
The Candidate
Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology) with a minimum of 3 years related experience in the pharmaceutical manufacturing industry.
Strong background working with Change Controls and management of change control processes.
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.
Prior regulatory affairs, quality control or quality assurance experience is a must.
Working knowledge of US application regulations and cGMPs, and FDA Guidance for both.
Excellent organization skills and extreme attention to detail are a must.
Excellent oral and written communication skills.
Motivated, self-started, team player.
Able to reflect a strong quality work ethic.
Proven ability to multi-task and demonstrate diplomatic skills.
Proficient (excellent) English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.
Ability to effectively present information and respond to questions from peers, management, suppliers and customers.
Strong organizational, analytical, and investigative skills, including ability to solve problems with minimal guidance, a must.
Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
Working knowledge of cGMPs and/or OSHA regulations required.
Ability to solve problems with little guidance. Ability to identify most efficient method in order to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individual 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
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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.
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.
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