Senior Quality Assurance Specialist
The Senior Quality Assurance Specialist will be responsible for managing and documenting events and/or discrepancies associated with product or process.
Position Summary
This position is 100% on-site at the St. Petersburg site.
Work Hours: 1pm-10pm
Join Catalent’s flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility.
The role is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification programs.
The Role
Serves as first point of escalation for QA Specialists.
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.
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.
Serve as administrator (or back-up) to quality systems as assigned (Documentum, TrackWise, ComplianceWire) including coordination and implementation of site support of corporate initiatives.
Other duties as assigned.
The Candidate
Bachelor’s Degree in science or Engineering required (Chemistry, Microbiology or Biology preferred) with at least three 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 is required.
Prior experience with preparing annual product reviews preferred.
Skilled at leading groups (e.g. Kaizen events or other improvement initiatives)
Proficient English verbal and written communication skills to convey and receive ideas and instructions with those from within and outside the organization.
Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access)
Working knowledge of cGMPs and/or OSHA regulations
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 DisabilityAccommodations@catalent.com. 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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