QC Analyst III, Analytical - LSA

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Medical, dental and vision insurance

Paid Time Off (PTO)

Dynamic working culture

Job summary

Lonza is seeking a QC Analyst III in Portsmouth, NH, to execute critical cGMP release testing and manage investigations. This senior role requires 3-4+ years of lab experience, focusing on complex testing techniques and method validations.

The ideal candidate holds a Bachelor’s Degree in a science discipline and possesses robust communication skills. Join Lonza for a dynamic working culture and comprehensive benefits including medical insurance and PTO.

Qualifications

• 3-4+ years of direct Quality Control laboratory experience in cGMP biomanufacturing.
• Proven experience in performing various immunological assay techniques.
• Excellent written and oral communication skills.

Responsibilities

• Execute complex biological and cell-based testing.
• Lead laboratory investigations and address non-conformances.
• Train junior QC personnel and deliver hands-on training.

Skills

Quality Control laboratory experience

Cell culture maintenance

Immunophenotyping panels via flow cytometry

PCR amplification

Good Documentation Practices

Education

Bachelor’s Degree in Biochemistry, Biology, or a related field

Master’s Degree in a scientific discipline

Tools

Laboratory Information Management Systems (LIMS)

TrackWise

Job description

QC Analyst III, Analytical - Large Scale Allogenic Manufacturing

United States, Portsmouth (New Hampshire)

Location: Portsmouth, NH, USA.

Schedule: Monday - Friday, 0800-1700

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.

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 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

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.

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.