QA Research Associate
Where
- Charlotte, NC
What you'll be doing
- Conduct quality assurance assessments of pre clinical and clinical research. Perform the processes of QA including but are not limited to: developing SOPs; developing process checklists, project audits and methodology and standards development. Manage the QA daily work activities including: workload, general guidance to support team members and across functional groups, and serve as resource for technical/administrative problems. Assist in writing, editing, reviewing, and implementing standard operating procedures (SOPs), master batch records, stability, assay and equipment protocols and specifications. Assist research team members in QA operations as needed, including batch record, protocol, and data review. Assist with preparation of technical reports, product specifications and regulatory submissions. Support internal and external audits including but not limited to: meetings, teleconferences regarding QA issues with the FDA and other regulatory agencies.
What your background should be
- Required long periods of sitting or standing and some walking. Occasional lifting of supplies, equipment, etc. Work in research laboratories with a variety of chemicals and biological agents, some that may be hazardous. Work in vivarium area where animals are present. Experience with GLP, GCP and GMP preferred. Knowledge of FDA, EPA, OSHA and other agencies required. Animal experience preferred.
Required Schooling / Training
- Bachelor Degree with 5 years of experience in research compliance, or master Degree with 3 years of experience in research compliance or regulatory affairs required.
Who is the client company
- This is a non profit hospital network which operates hospitals, freestanding emergency departments, urgent care centers, and medical practices in the American states of North and South Carolina.
- If you are interested in this position, send your resume to apply@kochdavis.com
