Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Location: 6101 Quadrangle Drive, Chapel Hill, NC 27517

Duration: Fulltime Direct Hire

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 to be 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 MasterControl 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.

Must Have:

GMP Knowledge.

Nice to Have:

Master Control Knowledge.

Tissue Culture > Cell Culture.