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Form of workJob Description
Job title: QA Specialist
Job Location: Chapel Hill, NC
Job Duration: Direct Hire
Job Description:
Technical Skills
Nice To Have:
Job Description:
Custom Fields
Work Location:
Onsite/Hybrid Parking
Parking Available
Minimum Years Of Experience Required: Three
Minimum Years Of Education Required: Four
Job Location: Chapel Hill, NC
Job Duration: Direct Hire
Job Description:
Technical Skills
- Must Have
- GMP Knowledge
Nice To Have:
- Master Control Knowledge
- Tissue Culture > Cell Culture
Job Description:
- Batch Record Issuance
- Assists in the process of creating batch records and forms needed to support the process.
- Batch Review
- Completes initial review of batch records in real time and provides feedback on manufacturing operations.
- Coordinates with QC -Equipment and QC – EM Roles on manufacturing needs.
- Initiates and investigates Occurrences that occur during manufacturing.
- Responsible for tracking manufacturing errors and providing feedback for metrics.
- Technical Writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.
- Assists and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.
- Ensures manufacturing employees are current on required training for them to complete operations.
- Looks to implement and reinforce best practices used in manufacturing operations in conjunction with production staff.
- Helps the liaison for manufacturing to support projects.
- Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.
- Assist in training other QA/QC members in ACT Quality Systems.
- Assist in the maintenance of quality electronic systems.
- Participate in 10 hours of continuing education annually in cellular therapy or quality topics.
- Experience with Master Control beneficial.
- Responsibilities may be modified or added as needed and discussed with the Assistant Director of QA/QC and/or Associate Director of Quality and Facility Director.
Custom Fields
Work Location:
- Onsite
Onsite/Hybrid Parking
Parking Available
Minimum Years Of Experience Required: Three
Minimum Years Of Education Required: Four
