QC Specialist 2

About the role

The QC Technical Transfer Analyst 3 supports the Quality Control department by performing analytical testing, executing technical transfer activities, and maintaining GMP-compliant documentation. The role involves semi-routine testing, data interpretation, software system usage, and participation in investigations, method transfers, and validation projects. The analyst must be able to recognize deviations, solve moderate-scope problems, and communicate effectively with cross-functional teams.

Responsibilities

• Perform QC testing for In-Process, Lot Release, Stability, investigations, transfers, and validations.
• Review assays and ensure compliance with GMP, Data Integrity, and Lonza policies.
• Write and manage Quality Records: Deviations, CAPA, Change Control, EICRs, Investigations, Test Methods.
• Support method transfers, new instrument onboarding, and method qualifications.
• Train team members on QC processes and laboratory systems.
• Use QC software systems: SoftmaxPro, Empower, SoloVPE, TrackWise, LIMS, Microsoft Office Suite.
• Execute software validation tasks: writing GMP procedures, validation documents, test scripts.
• Act as SME for at least one QC software system.
• Perform root-cause analysis for software-related issues.
• Apply Data Integrity principles in all work activities.
• Communicate with cross-functional teams to understand priorities and project needs.
• Complete assigned tasks accurately and on time; maintain positive team communication.
• Follow all assigned training and maintain compliance with GMP requirements.
• Perform other duties as assigned.

Requirements

• Associate's Degree in Microbiology, Biochemistry, Biotechnology, Chemistry, or related scientific field.
• 3–5 years experience in Quality Control within a GMP pharmaceutical or biotech environment.
• Hands-on experience with:
  • Change Control, Deviations, CAPA, Investigations
  • QC testing (release, stability, in-process)
  • Laboratory software systems (SoftmaxPro, Empower, SoloVPE)
  • GMP documentation and software validation
• Ability to interpret data, solve moderate-scope problems, and communicate clearly.
• Experience working in cross-functional teams and supporting technical transfer projects.