Location: South Plainfield, New Jersey, United States of America
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 Standard Operating Procedures (SOPs)
Coordinate corrections to laboratory documents and electronic data to ensure compliance with regulatory and in-house requirements
Monitor tracking systems such as instrument calibrations and maintenance and collaborate with relevant personnel or business units as appropriate
Assist in the oversight of the archive room including proper indexing and storage of required records
Print and distribute key Quality Assurance documents such as notebooks, maintenance logbooks, usage logbooks and other controlled documents
Assist with maintenance of the SOP system including tracking, printing, distributing and filing current and previous SOP versions
Assist Senior Quality Assurance personnel in applicable tasks related to the Quality Management System.
Candidate Qualification (Education/ Experience/ Attributes)
- Bachelor’s Degree in Life Sciences or equivalent years of related work experience
- Minimum of one year of working experience in a GLP/cGMP environment
- Demonstrated proficiency in Microsoft Office, especially Excel
- Strong verbal and written communications skills
- Detail oriented with strong organizational skills
- Demonstrate an ability to work independently and within a team.