QA Specialist

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.

Job Responsibilities:

• 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.

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