Position Summary:
The Technician I, QA - Finishing provides direct support for all manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing activities occurring in classified cleanroom areas.
Job Responsibilities:
- Verification of IV bag BOM's
- Monitors pharmaceutical operations in daily inspection activities to ensure personnel are following procedures
- Perform QA inspection of finished drug product units and samples for release/stability testing
- Manages reject cage for rejected finished drug products
- Retrieves finished drug product sample requests and delivers them to requestor
- Administer/ prepare inspector qualification tests
- Assist in writing, revising, & reviewing SOPs for applicable areas
- Initiate material evaluation reports (MER) for destruction of expired finished drug products
- Make defects for automated inspection defect kits
- Perform QA inspection of labeled finished product vials
- Provide QA oversight to pharmaceutical Operations and perform acceptance quality limit (AQL) inspection
- Reconcile and review executed batch production records for batch release
- Ensure outgoing shipments meet guidelines and provide QA approva;
- Acknowledge serialization information is accurate and provide approval after packaging activities
- Review batch records during active manufacturing
- Perform routine manufacturing area line clearances
- Maintain gowning qualification for access to aseptic manufacturing areas
- Perform Quality Assurance compliance review of manufacturing, maintenance, and quality logbooks and records
- Assist in routine filing of Quality records
- Perform bi-weekly and monthly quality walkthroughs of various cleanroom classified locations
- Assist level 2's and leads with writing and revising SOP's, deviations and CAPAs when applicable under direct supervision
- Perform other duties as assigned
Required Skills:
- Excellent interpersonal skills and the ability to communicate well orally and in writing
- Ability to multi-task and handle multiple priorities in a dynamic environment with changing priorities
- Attention to details
- Team player willing to work with everyone
Education and Experience Requirements:
- Bachelor's degree in a science or related field is strongly desired, or High School diploma with 3+ years relevant GMP or regulated industry experience
- Experience supporting manufacturing is preferred
- Experience with computers, including Microsoft Office, Windows
EOE, including disability/vets.
|
