GMP QA Operations Specialist IV | Night Shift

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

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.