Sr. Quality Control Associate - Microbiology

US-GA-Union City
Job ID
2017-1081
Category
Quality Control
Shift
Union City - QC Microbiology - Monday, Tuesday& Wednesday 4AM to 4PM

Overview

The Senior Quality Control Associate is accountable for laboratory support of Dendreon’s products and in accordance with appropriate regulatory, corporate and scientific guidelines. This individual will assist with testing, general laboratory maintenance and will routinely execute environmental monitoring in classified cleanroom environments. Enthusiasm for learning and commitment to our patients, as well as the ability to function in a fast-paced, highly technical environment are essential for success.

 

Responsibilities

  • Perform in-process and final product sterility testing of Dendreon products (e.g., sterility by BacT/Alert)
  • Perform routine environmental monitoring sample collection and testing (e.g., MetOne particle counting, Gram stain, microbial identification)
  • Receive and maintain test samples, reagents and reference standards used in the laboratory per approved procedures
  • Adhere to good documentation practices to ensure data integrity and traceability
  • Perform routine equipment maintenance
  • Interact with general facility staff to support cleanroom gowning qualifications and perform laboratory and facility deviation investigations.
  • Create and revise facility and laboratory procedures
  • Serve as Trainer/Mentor to QC Associate I position
  • Coordinate key function(s) involving colleagues within the laboratory and/or related departments within the facility

Qualifications

  • Associate’s degree in a scientific discipline or equivalent at minimum, Bachelor’s degree desired
  • 2 years related experience in cGMP/FDA regulated industry
  • Knowledge of cGMP/ICH/FDA regulations preferred
  • Experience with computerized systems
  • Proficient in MS Word, Excel, Outlook and Project
  • Strong oral and written communication skills

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