What are the responsibilities and job description for the QC Specialist 2 position at Katalyst CRO?
Job Description
The QC Technical Transfer Analyst 3 supports the Quality Control department by performing analytical testing, executing technical transfer activities, and maintaining GMPcompliant documentation. The role involves semiroutine testing, data interpretation, software system usage, and participation in investigations, method transfers, and validation projects. The analyst must be able to recognize deviations, solve moderatescope problems, and communicate effectively with crossfunctional teams.
Responsibilities
The QC Technical Transfer Analyst 3 supports the Quality Control department by performing analytical testing, executing technical transfer activities, and maintaining GMPcompliant documentation. The role involves semiroutine testing, data interpretation, software system usage, and participation in investigations, method transfers, and validation projects. The analyst must be able to recognize deviations, solve moderatescope problems, and communicate effectively with crossfunctional teams.
Responsibilities
- Perform QC testing for InProcess, 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 rootcause analysis for softwarerelated issues.
- Apply Data Integrity principles in all work activities.
- Communicate with crossfunctional 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.
- Associate's Degree in Microbiology, Biochemistry, Biotechnology, Chemistry, or related scientific field.
- 35 years experience in Quality Control within a GMP pharmaceutical or biotech environment.
- Handson experience with:
- Change Control, Deviations, CAPA, Investigations
- QC testing (release, stability, inprocess)
- Laboratory software systems (SoftmaxPro, Empower, SoloVPE)
- GMP documentation and software validation.
- Ability to interpret data, solve moderatescope problems, and communicate clearly.
- Experience working in crossfunctional teams and supporting technical transfer projects.