QA Compliance Specialist - LSA

Lonza • Portsmouth, NH

1d • Onsite

About The Position

The QA Compliance Specialist supports the site's Quality Systems and Compliance programs by helping ensure adherence to GMP regulations, internal quality standards, and regulatory requirements. This role partners with Manufacturing, Quality Control, Validation, Engineering, and other functional teams to support quality events, quality systems activities, inspection readiness efforts, and continuous improvement initiatives.

Requirements

• 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, green-field environment
• Excellent written and verbal communication skills with the ability to effectively collaborate across departments

Nice To Haves

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or a related scientific discipline preferred
• Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, MasterControl, or similar platforms preferred

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

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level