GMP QA Specialist II — Night Shift (12-hr)

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

Benefits offered by this job

Bonus

Health insurance

401(k) matching

Life insurance & disability

Employee assistance

Paid time off

Job summary

Lonza is seeking a QA Specialist II – Operations to join our Portsmouth, NH team on a 12-hour rotating night schedule. This role provides on-the-floor QA support for GMP activities and partners with manufacturing teams to ensure compliance, data integrity, and robust documentation practices.

The ideal candidate will have a science or engineering background, familiarity with GMP and SOPs, and experience with quality systems such as SAP or TrackWise.

Qualifications

• Associate or bachelor’s degree in a scientific or engineering discipline preferred; equivalent relevant experience may be considered.
• Basic understanding of cGMP regulations and good documentation practices.
• Familiarity with manufacturing and quality systems such as SAP, LIMS, TrackWise, Syncade, or similar systems preferred.

Responsibilities

• Provide on-the-floor QA support for GMP manufacturing activities with autonomy and collaboration with GMP operators and manufacturing teams.
• Ensure compliance with GMP standards, data integrity, and internal quality procedures.
• Assist with inspection readiness, guide less experienced staff, and escalate complex issues to senior QA staff when needed.
• Represent QA in cross-functional meetings to support compliant processes and documentation practices.

Skills

SOP adherence

Communication skills

Organizational skills

Education

Associate or Bachelor's degree in science/engineering

Tools

SAP

LIMS

TrackWise

Syncade

Job description

Lonza is seeking a QA Specialist II – Operations to join our Portsmouth, NH team on a 12-hour rotating night schedule. This role provides on-the-floor QA support for GMP activities and partners with manufacturing teams to ensure compliance, data integrity, and robust documentation practices.

The ideal candidate will have a science or engineering background, familiarity with GMP and SOPs, and experience with quality systems such as SAP or TrackWise.