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QC Specialist 2

Karwell Technologies

Portsmouth, NH

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JOB DETAILS
SKILLS
Analysis Skills, Assays, Biochemistry, Biotech and Pharmaceutical, Change Control, Chemistry, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Quality, Documentation, GMP (Good Manufacturing Practices), Laboratory Information Management System (LIMS), Laboratory Systems, Maintain Compliance, Microbiology, Microsoft Office, Needs Assessment, Onboarding, Problem Solving Skills, Procedure Development, Project Evaluation, Quality Assurance Methodology, Quality Control, Quality Management, Records Management, Root Cause Analysis, Software Validation, Team Player, Technical Support, Test Data, Test Scripts, Testing, Time Management, Validation Documentation
LOCATION
Portsmouth, NH
POSTED
12 days ago
Job Description:
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:

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.

About the Company

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Karwell Technologies