Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Gaithersburg, MD. The candidate will assist in monitoring work to assure Good Laboratory Practice (GLP) and regulations are met.
- Monitors studies to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP and regulations.
- Provides GLP and training to company employees
- Assists in the oversight of maintaining the Standard Operating Procedures (SOPs).
- Maintains a copy of all protocols and the Master Schedule of all nonclinical laboratory studies
- Inspects nonclinical laboratory studies at adequate intervals to assure integrity of studies and maintains written records.
- Determines that no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.
- Reviews final study reports to assure that the reports accurately describe the methods and SOPs and raw data.
- Prepares and signs quality assurance statement included with the final study report.
- Assures 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 Dom Santoro at 215-531-5280.
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.