QA Operations Specialist IV - LSA (Nightshift)

public.client.lonza.display.name; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, short-term and long‑m/

Job summary

Lonza in Portsmouth, NH seeks an experienced QA Operations Specialist IV to provide real-time quality oversight for GMP manufacturing on the night shift. This role acts as a key quality presence on the floor, ensuring compliance, guiding decisions, and mentoring others in GMP practices.

You will rotate through GMP areas, review documentation, coach behaviors, and support manufacturing with issue triage, training, and escalation to senior management when needed.

Qualifications

• Bachelor’s degree in life sciences or equivalent experience.
• 8+ years in a cGMP pharmaceutical/biotech environment.
• Strong understanding of cGMP, ICH guidelines, and quality systems.
• Working knowledge of manufacturing operations (upstream/downstream, QC).
• Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, MS Office.
• Able to assess quality issues, make decisions, and escalate when needed.
• Strong communication and interpersonal skills to guide GMP on the shop floor.
• Experience in drug product manufacturing or QA operations preferred.

Responsibilities

• Rotate daily through GMP areas to review documentation and observe work habits, coaching GMP behaviors.
• Provide GMP guidance to Manufacturing for routine/non-routine issues and triage complexity.
• Respond to QA Hotline and make decisions, escalating to senior management when appropriate.
• Authorize placement/removal of Quality Tag Outs.
• Participate in Deviation lifecycle including minor deviations review/approval.
• Represent QA in meetings, audits, and decision-making with senior staff.
• Apply Data Integrity principles per Lonza policies.

Skills

GMP knowledge

Quality systems

Manufacturing operations

Issue assessment

Communication

Education

Bachelor’s degree in life sciences

Tools

TrackWise

SAP

LIMS

Syncade

Microsoft Office

Job description

QA Operations Specialist IV - LSA (Nightshift)

Location: This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM – 7:00 AM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.

What you will get:

Below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.

• Medical, dental and vision insurance.

• 401(k) matching plan.

• Life insurance, as well as short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What will you do:

We are seeking an experienced QA Operations Specialist IV to provide real-time quality oversight and on-the-floor support for GMP manufacturing operations. This role serves as a key quality presence within operational areas, ensuring compliance, supporting decision-making, and driving high standards of GMP execution. The ideal candidate brings strong technical expertise, sound judgment, and the ability to operate independently while mentoring others.

• Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits. Provide direct coaching and feedback for GMP and documentation behaviors. Conduct GMP training sessions as appropriate to support GMP work-habits and knowledge.

• Provide GMP guidance to Manufacturing for routine and non-routine issues. Is able to independently deal with complex and novel issues.

• Respond to QA Hotline calls in support of GMP operations. Quality Assurance Specialist IV is responsible for decision-making, from simple to complex decisions. They have the ability to independently assess quality issues and triage the majority of issues but also escal ate to Senior management when appropriate.

• Authorize placement and removal of Quality Tag Outs.

• Participate in Deviation lifecycle, including but not limited to, determination, review of minor deviations and approval of minor deviations

• Represent QA in meetings or on project teams, in audits, learning decision making as a QA representative conferring with senior staff and management.

• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.

• Perform other duties as assigned.

What we are looking for:

• Bachelor’s degree in life sciences discipline or equivalent experience

• 8+ years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment

• Strong understanding of cGMP, ICH guidelines, and quality systems

• Working knowledge of manufacturing operations, including upstream/downstream processes, QC, or related functions

• Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications

• Ability to independently assess quality issues, make sound decisions, and appropriately escal ate complex situations

• Strong communication and interpersonal skills, with the ability to provide clear guidance and influence GMP behaviors on the shop floor

• Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment preferred

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.