Quality Assurance Associate
Proclinical is recruiting for a Quality Assurance Associate with a medical research organization focused on bettering patient health management. As the Quality Assurance Associate, you monitor studies to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP and CAP regulations.
This position requires being onsite full-time in Gaithersburg, Maryland. Please do not apply if you want a remote only opportunity.
- Provide GLP and CAP training to employees
- Assist in the oversight of maintaining the Standard Operating Procedures (SOPs).
- Maintain a copy of all protocols and the Master Schedule of all nonclinical laboratory studies
- Inspect nonclinical laboratory studies at adequate intervals to assure integrity of studies and maintain written records.
- Determine that no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.
- Review final study reports to assure that the reports accurately describe the methods and SOPs and raw data.
- Prepare and sign quality assurance statement included with the final study report.
- Assure compliance with CFR Part 58 maintenance of records and indexing of the records.
Skills and Requirements:
- At least a Bachelors' level degree or equivalent experience.
- Excellent communication and organizational skills.
- Excellent editing and writing skills
- Training in Good Laboratory Practice (GLP) procedures.
If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.