QC Analyst III

Job Title: QC Analyst III
Location: 101 International Drive, Portsmouth, NH 03801
Duration: 12-Month Contract (Possible Extension or Conversion)
Pay Rate: $33/hour (W2)
Benefits: Weekly Pay + Medical, Dental, Vision Coverage

Role Summary:
The QC Analyst III – Technical Transfer supports Quality Control operations and production activities by contributing to technical transfer projects and performing laboratory testing. This role includes in-process, final product, stability, validation, and investigation testing, along with documentation and quality system support. The position requires strong analytical skills, GMP knowledge, and the ability to recognize and resolve deviations from standard practices.
Key Responsibilities:

• Support QC technical transfer activities and production testing needs
• Perform testing for in-process samples, lot release, and stability studies
• Execute testing for investigations, method transfers, and validations
• Review assay results and analytical data
• Assist with method transfers, new instrument onboarding, and method qualifications
• Train team members on procedures and systems when required
• Apply company policies, procedures, and job knowledge to complete varied and moderately complex tasks
• Identify deviations and investigate moderate-scope technical issues
• Follow Data Integrity (DI) principles in compliance with Lonza DI policies and guidelines
• Maintain current training status and compliance requirements
• Perform additional assigned duties as needed

Quality Systems & Documentation:

• Experience with Change Controls, Deviations, CAPAs, Investigations, Tasks, and EICRs
• Author and review GMP quality records and test methods
• Support software and system validation activities, including writing GMP procedures, validation protocols, and executing test scripts

Systems & Tools:

• Laboratory software: SoftMax Pro, Empower, SoloVPE
• GMP systems: TrackWise, LIMS (preferred)
• Microsoft Office Suite (Word, Excel, PowerPoint)
• Laboratory computer systems
• Acts as SME for at least one laboratory software platform

Technical & Professional Skills:

• Strong data interpretation and analytical skills
• Root-cause analysis for selected software or technical issues
• Ability to prioritize, problem-solve, and manage tasks/projects
• Effective written and verbal communication skills
• Comfortable presenting or speaking in group settings
• Exercises sound judgment within defined procedures
• Self-motivated, detail-oriented team player
• Consistently meets timelines and accuracy standards
• Maintains a positive, collaborative team attitude
• Reliable attendance and punctuality

Required Qualifications:

• Associate’s Degree in Microbiology, Biochemistry, or a related science field
• GMP experience within the pharmaceutical industry

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