Quality Assurance Specialist

Catalent Pharma Solutions•St. Petersburg, FL

4d•Onsite

About The Position

Quality Assurance Specialist The Quality Assurance 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 event; processing and investigating customer / consumer product complaints; preparing annual product reviews; and, tracking and trending and follow-up of the CAPA program. Position Summary This position is 100% on-site at the St. Petersburg site. 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 Quality Assurance Specialist interacts directly with manufacturing personnel and is responsible for maintaining a high-quality environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The Role Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality; collaboration includes reacting, investigating and following up with Operations for non-conformance issues and a working jointly towards resolution. Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead investigations 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. May author other types of quality system documents as directed or assigned by QA management. Liaise with customers to ensure customer requirements are satisfied. Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure Prepare annual product reports and ensure on time closure. Other duties as assigned.

Requirements

Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology)
A minimum of three years related experience in QA pharmaceutical manufacturing
Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred)
Working knowledge of cGMPs and/or OSHA regulations required
Ability to work effectively under pressure to meet deadlines
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
Specific vision requirements include reading of written documents and frequent use of computer monitor

Nice To Haves

prior experience with preparing annual product reviews preferred

Responsibilities

Managing and documenting events / discrepancies associated with either product or process
Managing / writing any investigations that may be a result of those event
Processing and investigating customer / consumer product complaints
Preparing annual product reviews
Tracking and trending and follow-up of the CAPA program
Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality
Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead investigations 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
May author other types of quality system documents as directed or assigned by QA management
Liaise with customers to ensure customer requirements are satisfied
Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure
Prepare annual product reports and ensure on time closure
Other duties as assigned