You are viewing a preview of this job. Log in or register to view more details about this job.

Quality Control Analyst

Randstad Life Sciences
Email

Title: Quality Control Analyst 
Location: Lexington, MA
Pay: $35-43/hr 
Contract: 6+ months 

Job Summary

Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.

Job Responsibilities 

  • Specific Biochemistry Focus Areas:
    • A280, SOLO A280, Compedia methods (pH. Moisture, OSMO,
      Appearance, Subvisible particles), Enzyme Actitity assays, DNA, PCR, Free Thiol 
  • 80%: Testing execution
  • 10%: QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab housekeeping, support for other QC groups if needed.
  • 10%: Compliance and quality systems (SOP revisions, input to quality system

Education & Qualifications 

  • Essential: Bachelor's degree and minimum of 0-2 years related experience
  • Desired: GMP knowledge, work experience
  • Limited use and/or application of basic principles, theories and concepts.
  • Limited knowledge of industry practices and standards.
  • Position requires
  • critical thinking.
  • MS Office
  • LIMS
  • SAP
  • Trackwise
  • EDMS
  • Compliance and strong science understanding
  • Solve routine problems of limited scope and complexity following established
  • policies and procedures. Works on problems of limited scope.
  • Follows standard practices and procedures in analyzing situations of data from which answers can be readily obtained.
  • Builds stable working relationships internally.
  • Repetitive bendings and reaching to setup and break down equipment
  • Ability to work around chemicals
  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases · Ability to walk and stand for periods of time