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.