Pace Analytical

Quality Assurance Data Reviewer

US-MN-Oakdale
ID
2017-1996
# of Openings
1
Category
Administrative/Clerical

Overview

The Company:

Pace Analytical Life Sciences (PLS) is an industry leading contract lab supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, and Life Sciences industry.  Since our formation in 2006 we have grown at a rate of over 10% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a wide range of clients worldwide.  We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service.

 

Summary:

We are actively seeking a candidate to join our Quality Assurance (QA) Data Review team. This is a non-laboratory position. The ideal candidate is one who thrives working in a highly dynamic, team- oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical and medical device products. 

 

The QA Data Reviewer is responsible for review of laboratory technical records.  Technical records can be documented in worksheets or electronically. Laboratory activities vary from routine, compendia type analyses to more complex client specific chromatographic methods, in support of testing pharmaceutical and medical device products. The QA Data Reviewer reports to the QA Group Leader.

 

The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of self-initiative and flexibility, a desire to collaborate with all departments and an interest in continuing to acquire new knowledge and skills. 

 

Preferred qualifications include either GMP laboratory or data review experience in basic wet chemistry and spectrophotometric techniques, such as UV-Vis, HPLC and GC.  Experience with Empower software is desirable.  

Responsibilities

  • Perform review of laboratory technical records while ensuring that client due dates are met.
  • Perform review of laboratory solutions records.
  • Perform laboratory equipment checks.
  • Provide support to other members of the QA Data Review Team.
  • Review and approve final analysis reports.
  • Develop and maintain computer skills related to work performed, including familiarity with laboratory computer applications (e.g., ELN, LIMS, Empower).
  • Assure all work performed is compliant with Pace Analytical Life Sciences SOPs and GMP requirements.
  • Become familiar and regularly updated with quality and regulatory policies associated with the technical area.
  • Participate in quality, cGMP, safety, method and technique training appropriate for their area.
  • Other tasks as assigned by group leader

Qualifications

  • Bachelors Degree in Chemistry preferable
  • 6 months – 1 year of laboratory experience, preferably in FDA regulated laboratory environment
  • Keen attention to detail and adherence to SOPs and Good Documentation Practices within a cGMP environment
  • Strong interpersonal skills
  • Strong verbal and written communication skills
  • Ability to excel in a fast-paced work environment
  • Ability to work independently, multi-task and be flexible with changing priorities
  • Bachelors Degree in Chemistry preferable
  • 6 months – 1 year of laboratory experience, preferably in FDA regulated laboratory environment
  • Empower experience is desirable

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