About the position
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 Product Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems.
Responsibilities
- Primary quality liaison for clients and internal customers.
- Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.
- Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.
- Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems.
- Provide QA Technical recommendations based on trend analysis to eliminate future problems.
- Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.
- Provides feedback to the appropriate department regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines.
- Provide support to internal, client, and regulatory audits.
- Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
- All other duties as assigned.
Requirements
- Bachelor's Degree in Science (Chemistry, Microbiology or Biology preferred) required with a minimum of five years of related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
- Prior experience working with validation, manufacturing or product development 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.
- Prior quality assurance experience is required.
- Working knowledge of cGMPs and/or OSHA regulations required.
- Excellent oral and written communication skills a must.
- Ability to speak effectively and present before groups within the organization.
- Ability to review and evaluate technical documents and determine impact to processes and systems in place.
- Ability to work effectively under pressure to meet deadlines.
Nice-to-haves
- Certified Quality Engineer is a plus.
Benefits
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
