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QC Analyst III

Summary:

Join a cutting-edge biotech leader in Portsmouth, NH, as a QC Analyst 3. This 8-month, 100% on-site contract role offers the chance to support critical cGMP manufacturing by executing technical transfer activities, method/software validations, and data integrity initiatives in a fast-paced laboratory setting.

 

 

Responsibilities:

  • Lead method and software validations, including writing GMP procedures, executing test scripts, and authoring validation documents.
  • Serve as a Subject Matter Expert (SME) for key laboratory software platforms.
  • Execute root-cause analyses to troubleshoot complex technical software errors.
  • Collaborate across cross-functional teams to translate operational needs into actionable priorities.
  • Enforce rigorous Data Integrity principles across all laboratory workflows in strict compliance with GMP guidelines.

 

Qualifications: 

Required:

  • Bachelor's degree in a science-related discipline.
  • Proven experience with specialized analytical software: SoftmaxPro, Empower, or SoloVPE.
  • Direct GMP experience within the pharmaceutical or biotechnology industry.
  • Proficiency with laboratory computer systems and data interpretation.

Preferred:

  • Prior experience with GMP Quality Systems such as TrackWise or LIMS.