Sr. QA/RA Compliance Specialist

Company: Disability Solutions
Location: Saint Petersburg
Posted on: September 29, 2024

Job Description:

Sr. QA/RA Compliance SpecialistPosition SummarySt. 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. QA/RA Compliance Specialist--is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints, preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs. The Sr. 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.The Role

• 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 timely manner.
• Interact with Customers and gather information as needed to support registration activities.
• Provide regulatory impact assessment on all change controls as required.
• 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.
• 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.
• ---All other duties as assigned.The Candidate
  • Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology)
  • At least a minimum of 5 years of pharmaceutical industry experience directly related to QA/Regulatory Compliance
  • At least a minimum of 5 years' experience performing investigations and root cause analysis
  • At least a minimum of 5 years' experience preparing/supporting regulatory filings and/or APRs
  • Pathwise certification and/or RAC certification a plus
  • 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.
  • Proven ability to multi-task and demonstrate diplomatic skills.
  • 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 ProcessesCatalent 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 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Bradenton , Sr. QA/RA Compliance Specialist, Other , Saint Petersburg, Florida