QA Manager

QA Manager

Position Summary

The QA Manager is responsible for managing aspects of Quality Assurance representing a staff of approximately seven to twelve associates which includes oversight of QA Specialists supporting operations and Sr. QA Releasers responsible for the Quality Assurance review of all executed batch record documents and final product release.

Responsible for ensuring the site is in compliance with cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Pharma Solutions quality standards across the area of focus. Position requires partnership with other functional areas (e.g. Product Development, Operations, Customer Service, Validation, Quality Control, etc.) to ensure continued compliance for the area/site. Will provide directional support and as required, hands on, leadership to drive actions and enhancements to the QMS.

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.

The Role

• Ensure Quality systems are compliant with corporate and site procedures, regulatory requirements and industry standards for systems such as Deviation investigations, Batch record review, Equipment/Facilities, root cause analysis, Corrective and Preventive Actions,
• Drive continuous improvement initiatives in previously listed QMS.
• Oversees Deviation investigation system to ensure timely closure of deviations, corrective actions, effectiveness checks, etc.
• Ensures investigation teams conduct thorough root cause analysis, identifies, and implements corrective and preventive action plans to eliminate repeat observations and reviews/approves deviation investigations.
• Manages team routinely engaging in client interactions and client audits and participates in those activities as needed.
• Manages team responsible for performing batch record review and disposition activities for commercial and clinical trial batches.
• Other duties as assigned.

The Candidate

• Bachelor's Degree Required
• Bachelor's degree in science (Chemistry, Microbiology or Biology preferred) preferred however relevant years of experience will be considered.
• A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
• Experience working with customers - Contract manufacturing experience preferred.
• Prior experience working with validation or technical services preferred.
• Proven ability to multi-task and demonstrate diplomatic skills.
• Must possess excellent English verbal and written communication skills.
• Intermediate to proficient skills in Microsoft Office applications

Why You Should Join Catalent

• Competitive medical benefits and 401K
• 152 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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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