Location: South Plainfield, New Jersey, United States of America
The QA Specialist is responsible for the effective implementation, management, and auditing of the Quality System. Additionally, they support various quality management initiatives and execute various tasks associated with the Quality System.
- Interact with all personnel levels and departments to oversee and ensure compliance with internal Quality System requirements.
- Perform various Quality System activities including assessment and closure of nonconformances, change control and CAPAs.
- Conduct internal audits of the Quality System, facility, and laboratory studies.
- Implement process improvements to enhance the Quality System and facilitate compliance.
- Lead and support updates to various quality-related documents and procedures.
- Provide support for customer audits and regulatory inspections as needed.
- Other duties as required.
- Bachelor’s Degree in Life Sciences or equivalent years of related work experience required
- 2+ years of experience in a GLP/cGMP environment required
- Ability to react to situations with a “sense of urgency”, accountability and collaboration
- Proficient in Microsoft Office, especially Excel
- Strong verbal and written communication skills are essential
- Detail oriented with strong organizational skills