QA Documentation Specialist 2

QA Specialist II – Contractor – 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 settings, 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:

• Serve as a Subject Matter Expert (SME) for Quality Assurance document review relevant to equipment, instrumentation, validation maintenance, CSV, and analytical systems.

• Independently review and approve GMP documentation within Document Management Systems (DMS), including SOPs, Work Instructions, eBRs, automation docs, forms, and checklists.

• Review and approve electronic and paper validation/qualification protocols and summary reports for site equipment, analytical systems, and computer systems.

• Review non-DMS quality documents including QA/Engineering preventative maintenance forms, CMMS records, functional equivalent memos, and audit trail periodic reviews.

• Partner directly with cross-functional teams (Manufacturing, QC, CSV, and global gLIMS teams) to resolve quality issues, document comments, and procedural discrepancies.

• Ensure all changes are properly justified and strictly apply Data Integrity (DI) principles across all documentation in compliance with Lonza policies.

• Participate in routine site meetings, data queries, and quality reporting compilation as assigned by management.

What we are looking for:

• Bachelor of Science degree in a science-related discipline or equivalent relevant experience required.

• 5–10 years of advanced Quality Assurance experience in a regulated Biotech, Pharma, or GMP environment.

• Extensive background in QA document review, validation processes, Computer System Validation (CSV), and LIMS/gLIMS systems.

• Strong working knowledge of cGMP regulations (e.g., 21 CFR Parts 210, 211, 820, and ICH guidelines) and electronic quality systems (e.g., TrackWise, DMS, SAP, Syncade).

• Demonstrated experience with Quality Management Systems, including handling deviations, CAPAs, change controls, and escalation pathways.

• Excellent written and verbal communication skills with strong project coordination, problem-solving, and cross-functional collaboration abilities.

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.