QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Biological Sciences, Laboratory Technician
  3. United States
Gaithersburg, USA
Posting date: 04 Jun 2021

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.