QA Operations Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Lancaster, Pennsylvania
Posting date: 28 May 2019

ProClinical is currently recruiting for a QA Operations Specialist position on behalf of a top 10 global pharmaceutical company. This organization develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in Pennsylvania, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the Scientific field.

Job Responsibilities:

  • 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 (batch record issuance and review, room release, event assessment, documentation review, etc).
  • Following-up on any issues concerned with quality documentation (e.g., investigations, deviations, and other required documentation).
  • Performing review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
  • Alerting management of production trends which may serve as forewarning of process or equipment problems.

Skills and Requirements:

  • BS/BA in biology, chemical engineering, or life sciences; Degree in other discipline if sufficient technical depth has been achieved from professional experience.
  • Aseptic gowning experience preferred; gowning and presence in aseptic areas required.
  • QA and/or GMP experience.
  • Working knowledge of pharmaceutical facilities, equipment, and systems preferred, including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
  • Experience working in Aseptic processing environment/Knowledge of Aseptic behaviours preferred.
  • Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance.
  • Working knowledge of validation principles, quality systems (Deviations, CAPAs, Change controls), and FDA regulations.
  • Demonstrable multitasking, project management, and execution skills.
  • 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.

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.