Sr. QA Specialist

Sr. Quality Assurance Specialist

The Sr. QA Specialist is responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may be a result of those events; processing and investigating customer/ consumer product complaints; preparing annual product reviews; tracking, trending and follow-up of the CAPA programs.

Position Summary

This position is 100% on-site at the St. Petersburg site.

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.

This position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification Programs.

The Role

• Assist in organizing and prioritizing the activities and schedule for the QA Specialists.

• Provides feedback to QA Supervisor and Manager on performance of QA Specialists.

• Responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions.

• Collaborates with management and supervisory personnel from operations, quality control and quality assurance to resolve problems affecting product quality; collaboration includes rating, investigating and following up with operators for non-conformance issues and working jointly towards resolution.

• Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead cross functional team to classify events and deviations of non-compliant issues according to procedures as defined by SOPs.

• 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.

• Prepare annual product reports and ensure on time closure. Author/compile monthly, quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.

• Other duties as assigned.

The Candidate

• Bachelor’s Degree in science or Engineering required (Chemistry, Microbiology or Biology preferred) and a minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or manufacturing pharmaceutical operation.

• Prior experience working with investigation writing, including root cause analysis and report writing a must.

• Prior experience with preparing annual product reviews preferred.

• Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access). Working knowledge of cGMPs and/or OSHA regulations.

• Ability to work effectively under pressure to meet deadlines. 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. Vision requirements include to have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.

Why You Should Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays

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 [email protected]. 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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