Pace Analytical

QA Data Review Specialist - Microbiology

US-MN-Oakdale
ID
2017-1993
# of Openings
1
Category
Science

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 an experienced candidate to join our Quality Assurance (QA) Data Review team for the Microbiology group. 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 Review Specialist is responsible for review of microbiology laboratory activity records.  Activity records can be documented in notebooks, on worksheets or electronically. Activities include sterility, non-sterility, media QC and environmental monitoring, in support of testing samples from pharmaceutical and medical device clients. The QA Data Review Specialist reports to the QA Group Leader.

 

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

 

Preferred technical qualifications include at least one year of experience working in a GMP microbiology laboratory and/or experience in QA review of microbiology data in a GMP environment.  

Responsibilities

  • Perform review of microbiology laboratory activity records while ensuring that client due dates are met
  • Perform review of media quality control activity records
  • Perform review of environmental monitoring records
  • Perform laboratory logbook and 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., LIMS, ELN, Word, Excel)
  • Assure all work performed is compliant with Pace Analytical Life Sciences SOPs and general regulatory 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
  • Other tasks as assigned by management

Qualifications

  • Bachelor’s Degree in Biology or other science-related field is preferable
  • 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
  • One year microbiology laboratory or data review experience, preferably in a GMP laboratory environment

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