QA Specialist

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. United States
Saint Paul, Minnesota
Posting date: 29 Apr 2019

ProClinical is advertising a vacancy for a QA Specialist position with a leading pharmaceutical, biopharmaceutical, and medical device capability company. The organisation provides comprehensive platform capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, and cell and gene therapy R&D. The QA Specialist will join this company in their office in Minnesota. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.

The primary responsibilities of the Quality Specialist include ensuring GLP studies, GMP testing, and GMP manufacturing activities are executed in accordance with the appropriate regulatory bodies and internal procedures. In addition, the Quality Specialist is responsible for performing internal audits, ensuring timely completion of investigation documents, and providing training to peers on systemic requirements.

Job Responsibilities:

  • Ensures compliance to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.
  • Performs audits (critical phase and manufacturing) and appropriately documents the findings.
  • Reviews final reports (GLP), batch records (cGMP), Certificates of Analysis (GMP), and/or other necessary documentation, as appropriate to the defined Quality Role within the applicable regulation(s).
  • Leads and/or assists with internal audits.
  • Performs QC review activities, where applicable.
  • Contributes to all phases (initiation, review, and approval) of investigations, CAPAs, and VOE actions.
  • Provides training to peers.
  • Serves as queue manager on a rotating basis.
  • Ability to work in a team environment and independently.
  • May be required to work weekends.
  • May be required to work Holidays.
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.

Skills and Requirements:

  • Minimum 2 years of experience.
  • Bachelor's Degree or equivalent.
  • Scientific background preferred.
  • 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 Mike Raletz at +267-428-7770 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.