Sr. QA Specialist

Catalent•Saint Petersburg, FL

3d•Onsite

About The Position

The Sr. QA 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 events; processing and investigating customer/ consumer product complaints; preparing annual product reviews; tracking, trending and follow-up of the CAPA programs. Position Summary This position is 100% on-site at the St. Petersburg site. St. Petersburg is our primary Softgel 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. This position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification Programs.

Requirements

Bachelor’s Degree in science or Engineering required (Chemistry, Microbiology or Biology preferred) and a minimum of 3 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 a must.
Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access).
Working knowledge of cGMPs and/or OSHA regulations.
Ability to work effectively under pressure to meet deadlines.

Nice To Haves

Prior experience with preparing annual product reviews preferred.

Responsibilities

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.
Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead cross functional team to classify events and deviations of non-compliant 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.
Prepare annual product reports and ensure on time closure.
Author/compile monthly, quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.
Other duties as assigned.