QA Compliance Specialist - LSA

Location: Portsmouth, NH office

Schedule

Monday through Friday, 7:00 AM–4:00 PM EST

Benefits

• 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)

Responsibilities

• Support Quality Systems activities including deviations, CAPAs, change controls, investigations, and quality risk management processes
• Review quality records and documentation to ensure compliance with GMP requirements, site procedures, and regulatory expectations
• Assist with inspection readiness activities, including preparation for regulatory inspections, customer audits, and internal audits
• Support the tracking, trending, and reporting of Quality Metrics, KPIs, and compliance indicators
• Collaborate with cross-functional teams to identify compliance gaps and support implementation of corrective and preventive actions
• Provide GMP guidance and support to operational groups regarding quality systems and documentation requirements
• Assist with the development, revision, and management of SOPs and other quality-related documentation
• Support site quality initiatives, continuous improvement projects, training activities, and other compliance-related responsibilities as assigned

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or a related scientific discipline preferred
• Minimum of 3+ years of experience in Quality Assurance, Compliance, Quality Systems, or a related role within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment
• Working knowledge of cGMP regulations, FDA requirements, and applicable ICH guidelines
• Experience supporting deviations, CAPAs, change controls, investigations, and quality system processes
• Familiarity with regulatory inspections, customer audits, and inspection readiness activities
• Strong analytical, organizational, and problem-solving skills with attention to detail and compliance
• Ability to multitask and prioritize work in a dynamic, fast-paced environment
• Excellent written and verbal communication skills with the ability to effectively collaborate across departments
• Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, MasterControl, or similar platforms preferred

About the Company

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.