QC Specialist 2

• 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:

o Change Control, Deviations, CAPA, Investigations

o QC testing (release, stability, in‐process)

o Laboratory software systems (SoftmaxPro, Empower, SoloVPE)

o 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.