QC Analyst III, Analytical - LSA

Lonza Inc. in; Portsmouth (NH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Lonza in Portsmouth, NH, is seeking an experienced QC Analyst III in Analytical – Large Scale Allogenic Manufacturing. You will perform complex cGMP release testing, oversee method validation and transfer, and lead investigations with GDP adherence. Strong knowledge of flow cytometry, ELISA, PCR, and cell culture is required.

You will review data, maintain documentation, and mentor junior staff while working in a collaborative quality environment.

Qualifications

• 3–4+ years of direct QC laboratory experience in a cGMP biomanufacturing or regulated clinical testing setting.
• Experience performing cell culture maintenance and immunophenotyping panels via flow cytometry.
• Proficient in PCR amplification and standard immunological assay techniques.
• Familiar with LIMS, TrackWise, and quality systems software.

Responsibilities

• Execute advanced cGMP release testing using flow cytometry, ELISA, PCR, and cell culture.
• Lead assay transfer, qualification, and method validation activities.
• Review raw data, calculations, and logs per GDP and documentation standards.
• Own OOS investigations with root-cause analysis and CAPA/change control tasks.
• Develop and maintain SOPs, master forms, and test records.

Skills

Flow cytometry

ELISA

PCR

Cell culture

OOS investigations

CAPA

Root-cause analysis

Data review

Technical writing

Education

Bachelor's degree in Biochemistry or Biology

Master's degree preferred

Tools

LIMS

TrackWise

Enterprise data management

Job description

QC Analyst III, Analytical - LSA (Healthcare)

QC Analyst III, Analytical - Large Scale Allogenic Manufacturing

Location: Portsmouth, NH, USA.

Schedule: Monday - Friday, 8:00 AM-5:00 PM

We are seeking an advanced laboratory professional to join our Quality organization in Portsmouth, NH, as an Analyst III, QC Analytical. Operating under general supervision, this senior bench-based role executes critical cGMP release testing, handles method validation protocols, and drives complex laboratory investigations.

What will you get?

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• Medical, dental and vision insurance, as well as PTO and more

Advanced cGMP Release Testing:

Execute complex biological, immunological, and cell-based testing—specifically utilizing flow cytometry, ELISA, PCR assays, cell culture, and cell counting—ensuring total compliance with internal SOPs, USP, and EP guidelines to support on-time in-process control and final product release.

Assay Transfer & Method Validation:

Actively spearhead analytical method transfers, qualifications, and validation protocols, including onboarding new methodologies and configuring advanced laboratory instrumentation.

Data Review & Verification:

Review raw laboratory records, data calculations, and execution logs for absolute accuracy, protocol compliance, and strict adherence to Good Documentation Practices (GDP).

Investigation & OOS Ownership:

Lead comprehensive Out-of-Specification (OOS) and laboratory deviation investigations, leveraging root-cause analysis tools to address complex non-conformances with minimal support.

CAPA & Change Control Management:

Author, edit, and coordinate corrective and preventive actions (CAPAs) and detail structured Change Controls to promote compliance and continuous laboratory improvement with minimal support.

Document Architecture:

Develop, modify, and sustain standard operating procedures (SOPs), master forms, and test records to match evolving industry expectations and site improvements.

Peer Training & Floor Leadership:

Deliver hands-on, on-the-job training for junior QC personnel, reviewing data packets, modeling strong work ethics, and escalating critical laboratory anomalies to management as needed.

What we're looking for:

Experience:

3-4+ years of direct Quality Control laboratory experience within a cGMP biomanufacturing or regulated clinical testing setting is required.

Technical Mastery:

Proven, hands-on experience performing cell culture maintenance, immunophenotyping panels via flow cytometry, PCR amplification, and standard immunological assay techniques.

Systems & Digital Compliance:

Familiarity with Laboratory Information Management Systems (LIMS), enterprise data management applications, and quality systems software (such as TrackWise) is highly preferred.

Investigation Savvy:

Demonstrated ability to independently lead laboratory event investigations, formulate root-cause theories, and write clear, logical technical summaries.

Education:

Bachelor's Degree in Biochemistry, Biology, or a closely related technical science discipline is required. A Master's Degree in a scientific discipline is preferred.

Soft Skills:

Superior written and oral communication skills, a solutions-focused team attitude, and the personal initiative required to navigate multiple testing demands and overcome performance roadblocks without routine reminders.

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. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.