Quality Assurance Specialist

Quality Assurance 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 andcompliance and to the safety of every patient consumer and Catalent employee.

The Quality Assurance 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 event; processing and investigating customer / consumer product complaints; preparing annual product reviews; and tracking and trending and followup of the CAPA program. The Quality Assurance Specialist will directly interact with manufacturing personnel and is responsible for maintaining a highquality environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. Furthermore this position will participate in the internal audit program and may assist with Supplier Audits/Certification programs as well as customer audits.

Shift: Rotating 223 schedule 7 7

The Role

• Collaborates with management and supervisory personnel from Operations Quality Control and Quality.

• Assurance to resolve problems affecting product quality; collaboration includes reacting investigating and following up with Operations for nonconformance issues and a working jointly towards resolution.

• Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead investigations of noncompliant 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.

• May author other types of quality system documents as directed or assigned by QA management.

• Liaise with customers to ensure customer requirements are satisfied.

• Facilitate CAPA commitments and Effectiveness Checks including initiation tracking trending and closure

• All other duties as assigned.

The Candidate

• Bachelors Degree in Science or related field required (Chemistry Microbiology or Biology); with minimum of three years related experience in QA pharmaceutical manufacturing.

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

• Proven ability to multitask 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.

• Certified Quality Engineer is a plus.

• 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. Specific vision requirements include reading of written documents and frequent use of computer monitor.

Why You Should Join Catalent

• Competitive medical benefits and 401K

• 152 hours of PTO 8 Paid Holidays

• Dynamic fastpaced 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 7000 lifesaving and lifeenhancing 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.

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