QC Analyst 3

QC Analyst IV – Biochemistry – Portsmouth, NH

This is an office-first role based on site in Portsmouth, NH. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office and laboratory, with the flexibility to work remotely for 20% of your time (one day per week).

What you will get:

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Competitive hourly rate.

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Support the production of in-process and final product drug lots by performing, reviewing, and executing advanced analytical assays for release and customer stability studies.

• Act as laboratory Subject Matter Expert (SME) during regulatory audits and conduct pre-audit laboratory walkthroughs to drive site audit readiness.

• Manage laboratory analytical equipment readiness and troubleshooting across systems such as HPLC, UPLC, SoloVPE, CE (PA-800), icIEF (iCE3), RT-PCR, and spectrophotometers.

• Provide technical guidance, compliance mentoring, and peer review feedback to junior analysts, stepping in to delegate daily operational tasks as needed.

• Partner with cross-functional teams (Manufacturing, QA, MSAT, PV) to communicate operational status and escalate technical issues promptly.

• Initiate and assist with quality investigations, 6S initiatives, document revisions, work orders, and change controls for continuous laboratory improvement.

• Strictly apply Data Integrity (DI) principles and cGMP guidelines across all testing, data reviews, and documentation activities.

What we are looking for:

• Bachelor’s Degree in Biochemistry or a related scientific field required; equivalent combination of education and direct industry experience will be considered.

• 5–10 years of Quality Control experience within a cGMP biopharmaceutical environment.

• Advanced technical expertise in operating, maintaining, and troubleshooting complex analytical instrumentation (e.g., Agilent/Waters HPLC/UPLC, capillary electrophoresis, RT-PCR).

• Strong regulatory knowledge with experience hosting or speaking to auditors as a Subject Matter Expert.

• Proven ability to lead process improvement projects, execute root-cause investigations, and mentor team members.

• Excellent data interpretation, problem-solving, and written/verbal communication skills.

About Lonza

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

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.

Ready to play your part in shaping the future of life sciences? Apply now.