QA Specialist II – GMP Operations (3rd Shift)

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Bonus

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance programs

Paid time off

Job summary

Lonza Group Ltd. in Portsmouth, NH is seeking a QA Specialist II–Operations to provide real-time on-the-floor quality assurance support for GMP activities on a 12-hour rotating shift (7:00 PM – 7:00 AM).

The role requires strong cGMP knowledge, data integrity, and collaboration with manufacturing teams; you will review documentation, support inspection readiness, and coach staff while ensuring compliant processes.

Qualifications

• Familiarity with cGMP regulations and good documentation practices.
• Experience following SOPs and completing required documentation accurately.
• Knowledge of QA processes in a regulated manufacturing environment.
• Ability to recognize potential compliance issues and escalate appropriately.

Responsibilities

• Provide real-time QA support on the floor for GMP activities.
• Ensure adherence to GMP standards and data integrity principles.
• Support inspection readiness and coaching of less experienced staff.
• Maintain compliant processes and documentation practices.
• Review daily documentation and observe GMP practices.
• Escalate complex issues to senior QA staff or management.
• Respond to QA hotline and assist with GMP-related questions.

Skills

cGMP knowledge

Data integrity

SOP adherence

Documentation skills

Attention to detail

Communication

Education

Bachelor's or Associate degree in science/engineering

Tools

SAP

LIMS

TrackWise

Syncade

Job description

Lonza Group Ltd. in Portsmouth, NH is seeking a QA Specialist II–Operations to provide real-time on-the-floor quality assurance support for GMP activities on a 12-hour rotating shift (7:00 PM – 7:00 AM).

The role requires strong cGMP knowledge, data integrity, and collaboration with manufacturing teams; you will review documentation, support inspection readiness, and coach staff while ensuring compliant processes.