QA Specialist II-Operations

Lonza • Portsmouth, NH

2d • Onsite

About The Position

We are seeking a QA Specialist II – Operations to provide real-time Quality Assurance support for GMP manufacturing operations. In this role, you will partner closely with Manufacturing and other operational teams to promote compliance, support inspection readiness, and ensure GMP activities are executed in accordance with regulatory requirements and company quality standards. The QA Specialist II operates with increasing independence, supports more complex quality initiatives, and serves as a visible Quality presence on the manufacturing floor.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field. A combination of education and years of experience will be considered.
• 3–5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment within Quality Assurance or a related function
• Hands-on experience reviewing batch records, logbooks, and GMP documentation to ensure compliance with quality and regulatory requirements
• Solid understanding of cGMP regulations, ICH guidelines, Good Documentation Practices (GDP), and data integrity principles
• Working knowledge of critical manufacturing process steps and parameters, including areas such as fermentation, purification, and quality control
• Familiarity with deviation management, investigations, CAPAs, product changeovers, and equipment clearance requirements
• Experience with quality and manufacturing systems such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications
• Strong attention to detail with the ability to identify compliance risks, recognize abnormal or potentially impactful events, and escalate issues appropriately
• Effective communication, organizational, and time management skills with the ability to collaborate across Manufacturing, Quality, and support functions

Nice To Haves

• Experience supporting internal audits, customer audits, or regulatory inspections preferred

Responsibilities

• Perform routine floor oversight within GMP manufacturing areas, reviewing activities and documentation to ensure compliance with GMP requirements and quality standards
• Provide guidance and coaching to manufacturing personnel on GMP behaviors, documentation practices, and quality expectations
• Review batch records, logbooks, and other GMP documentation for accuracy, completeness, and compliance
• Support manufacturing operations by providing quality guidance for routine and non-routine events and escalating complex issues when appropriate
• Respond to QA Hotline calls and provide real-time support to operational areas during manufacturing activities
• Authorize placement and removal of Quality Tag Outs and support equipment clearance and product changeover activities
• Participate as the Quality representative on cross-functional meetings, investigations, and project teams while supporting site inspection readiness
• Apply data integrity principles in all aspects of work and support continuous improvement initiatives, audits, inspections, deviations, and quality-related activities 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