QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Rockville, USA
Posting date: 05 Jun 2020

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Rockville, MD.

Job Responsibilities:

  • Ensure all cGMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures
  • Perform technical review of cGMP documentation and Batch Records for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures
  • Provide advice and counsel on cGMP and related quality assurance issues to the value stream
  • Demonstrate sound decision making relating to quality issues
  • Provide on the floor QA support and perform QA Operations activities
  • Take initiative to resolve quality documentation concerns
  • Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes
  • React to and escalate production issues
  • Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary
  • Write and/or revise controlled documents in support of job responsibilities

Skills and Requirements:

  • BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience
  • QA experience preferred. Minimum 1 year also preferred

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

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.