QA Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Marietta, Pennsylvania
Posting date: 11 Mar 2019

ProClinical is advertising a vacancy for a QA Specialist position with a leading US biopharmaceutical organization. Based in Pennsylvania, this organization prides itself on its solid commercial portfolio of life-saving drugs across a range of therapy areas, along with a growing pipeline of investigational drugs. This is an exciting opportunity to join this company and provide expertise in regulation protocols.

Job Responsibilities:

  • Ensuring all cGMPs, validation, quality, safety, and environmental regulations are met whilst adhering to all safety guidelines and procedures.
  • Performing technical reviews of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
  • Providing advice and counsel on cGMP and related quality assurance issues to the value stream.
  • Providing on-the-floor QA support and performing QA Operations activities (e.g., bath record review, documentation review, product sampling, and oversight).
  • Reviewing and supporting discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, etc.
  • Reacting to and escalating production issues.
  • Routinely communicating and reporting deviations from procedures/processes to Quality Assurance Management and initiating appropriate action as necessary.
  • Writing and/or revising controlled documents in support of job responsibilities.

Skills and Requirements:

  • A BS/BA in biology, chemical engineering, or life sciences. Degrees in other disciplines will be considered with sufficient technical depth having been achieved from personal experience.
  • At least one year's experience in QA.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.
  • Mid-Senior Level.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at +267-477-3355 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.