Job Description

United States, Portsmouth (New Hampshire)

QC Analyst II – Environmental Monitoring (Cell Therapy, 2nd Shift)

Location: Portsmouth, NH, USA.

Schedule: 2nd Shift, 1:00 PM – 11:30 PM | Sunday – Wednesday

As a QC Analyst II supporting our Cell Therapy asset, you serve as a technical guardian of our most sensitive manufacturing environments. In the specialized world of Cell Therapy, environmental control is paramount to patient safety. This role is designed for an experienced Quality professional who is ready to take the next step in their career—moving beyond routine execution to perform assay reviews, technical problem-solving, and independent decision-making in a world-class CDMO.

What You’ll Get

  • Technical Ownership: Step up into a role where you arent just running tests, but reviewing assays and exercising judgment within defined practices to ensure site compliance.
  • Mission-Critical Impact: Your expertise in microbial control directly protects patient-derived batches that are the "last best hope" for individuals in need.
  • Work-Life Balance: Our 4x10 schedule (Sunday – Wednesday) provides three consistent days off every Thursday, Friday, and Saturday, allowing you to avoid the standard 5-day grind.
  • Full Lonza Benefits: Medical, dental, vision, 401(k), and performance-based incentives. lonza.com/careers/benefits .

What You’ll Do

  • Advanced Environmental Monitoring: Lead routine and production-active HVAC and Utility sampling throughout specialized Cell Therapy suites.
  • Assay Review & Execution: Run microbial test samples for In-Process, Lot Release, and Stability studies, and take on the responsibility of reviewing assays for accuracy and compliance.
  • Analytical Problem Solving: Work on problems of moderate scope, analyzing data and identifiable factors to recognize and escalate deviations from accepted practices.
  • Data Integrity Leadership: Apply and reinforce rigorous Data Integrity (DI) principles, ensuring all laboratory records meet Lonza’s strict quality guidelines.
  • Process Improvement: Participate in brainstorming and "GEMBA" walks to identify opportunities for process improvements and safer aseptic behaviors.
  • Collaborative Synergy: Act as a reliable and dependable member of the 2nd shift team, assisting in the planning and prioritization of tasks to meet fast-paced manufacturing demands.

Who We’re Looking For

  • Experience: 2–4 years of experience in Quality Control or a regulated Laboratory environment is required. You should have a proven track record of working within cGMP guidelines.
  • Education: Associate’s Degree in Microbiology, Biochemistry, or a related Science field is required. (A combination of education and experience will be considered).
  • Technical Skills: * Strong ability to interpret complex data both independently and with guidance.
    • Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS).
    • Ability to direct and plan small-scale tasks or projects within the team.
  • The Level II Mindset: We are looking for an analyst who treats errors as learning opportunities, maintains a positive attitude under pressure, and demonstrates "Business Acumen" by understanding how their work contributes to Lonza’s corporate success.
  • Reliability: Ability to consistently work the 1:00 PM – 11:30 PM schedule (Sunday–Wednesday) and arrive on time to ensure seamless shift handovers.
About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. Lonza is proud to be an equal opportunity employer.

Ready to exercise your expertise in Quality Control? Apply now.

Reference: R75395

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Job Details

Role Level: Not Applicable Work Type: Full-Time
Country: Philippines City: Portsmouth NH
Company Website: http://www.lonza.com Job Function: Quality Assurance & Control
Company Industry/
Sector:
Pharmaceutical Manufacturing

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