QA Specialist job in Gaithersburg, USA

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Job type: Permanent

Discipline: Biological Sciences, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

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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