Quality Control (QC) Analyst / Senior Analyst

Kelly® Science & Clinical is looking for a motivated Quality Control (QC) Analyst / Senior Analyst to join the QC analytical team. This individual will directly support the culture and operation of an early phase QC group.  This position will collaborate across functions and will have an opportunity to learn in a dynamic start up environment.

Type: Contract (6-month)
Shift: M-F, 1^st
Pay Range: Analyst – $28-$33/hr
                    Sr Analyst: $33-$40/hr

CORE ACCOUNTABILITIES
Specific responsibilities include: 

• With management supervision, perform QC Analytical laboratory testing and review for product release, stability, and in-process testing.
  

• Execute sample management tasks such as sample receipt, aliquoting, and sample chain of custody in support of manufacturing and QC testing
  

• Collaborate with the Analytical Development team to perform testing in support of method qualification and transfer, provide QC perspective and input for method troubleshooting activities
  

• Willingness to learn and participate in Operational Excellence/Continuous Improvement activities including application of OE/CI philosophies in a regulated laboratory environment
  

• Independently own daily laboratory tasks such as inventory management, critical reagent qualification, cell passaging, etc.
  

• Other responsibilities/duties as required to support QC Operations (i.e., QC Microbiology tasks, stability timepoint pulls, etc.)

The successful candidate will have:

• Analyst Level: Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 1 year in a cGMP regulated QC environment. Equivalent combinations of advanced education and experience will be considered.
  

• Senior Analyst Level: Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 2+ years in a cGMP regulated QC environment. Equivalent combinations of advanced education and experience will be considered.
  

• Quality Control experience in cGMP regulated laboratory
  

• Molecular biology background, including dPCR, ELISA, Flow Cytometry and Cell-based assays
  

• Ability to execute against approved documents (SOPs, Methods, Protocols, etc.) with basic knowledge of relevant pharmaceutical regulations and regulatory guidance
  

• A passion for teamwork and unwavering commitment to purpose, team success, and the championing of an outstanding workplace culture
  

• Ability to excel through teamwork, collaboration and effective knowledge sharing

Preferred Qualifications: 
 

• Experience with laboratory startup, quality systems, and analytical methods
  

• Laboratory experience and understanding of molecular assays including digital PCR, Flow Cytometry, ELISA and/or cell-based test methods
  

• Experience in cGMP cell and gene therapy manufacturing and/or testing facility

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