Location: South Plainfield, New Jersey, United States of America
Purpose of the Position:
The Quality Associate is responsible for reviewing and monitoring the compliance of laboratory records and electronic data. They will act as an independent reviewer of data, processes, and documentation, and will collaborate with various personnel to ensure record review and corrections are completed to enable timely transfer of client deliverables.
Key Focus Areas:
- Review study records, notebooks, logbooks and electronic data for completeness, accuracy, and compliance to applicable SOPs.
- Coordinate corrections to laboratory documents and electronic data to ensure compliance with regulatory and in-house requirements.
- Conduct internal facility, study and data audits.
- Provide support in customer audit preparation and documentation as needed.
- Monitor tracking systems such as instrument calibrations and maintenance and collaborate with relevant personnel or business units as appropriate.
- Support updates to various quality-related documents as required.
- Assist Senior QA personnel in applicable tasks related to the Quality System.
- Other duties as required.
Essential Education / Experience:
- Bachelor’s Degree in Life Sciences or equivalent years of related work experience
- 1+ years of experience in a GLP/cGMP environment
- Ability to react to situations with a “sense of urgency” and accountability
- Proficient in Microsoft Office, especially Excel
- Strong verbal and written communications skills are essential
- Detail oriented with strong organizational skills