Senior Quality Assurance Specialist

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