Quality Assurance Specialist

4 weeks ago


Plainsboro, United States Integrated Resources, Inc ( IRI ) Full time

Responsible for QA support of the warehouse and supply chain processes. This role will provide critical quality support to process to ensure compliant receipt, inspection and release of materials used in cGMP manufacturing operations. You will be essential to Quality floor support of the warehouse, aiding the effective resolution of deviations and nonconformances associated with materials, suppliers, and storage.

Support supplier quality management including change notifications and corrective action requests.

• Assist with the onboarding of new GMP materials and suppliers.

• Inspect labels, starting materials and fill/finish components before use in manufacturing.

• Responsible for writing, revising, reviewing and/or approving documents associated with GMP materials such as SOPs, work instructions, and protocols.

• Work cross-functionally to investigate and resolve deviations.

• Execute QA review and approval of master data. Verify chain of custody and complete final release of GMP raw materials.

• Identify and implement continuous improvement activities to eliminate waste and increase the efficiency and effectiveness of Quality oversight.

Qualification

Minimum B.S. degree; preferably in scientific field.

• Minimum 1 year related pharmacuetical quality assurance experience.



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