QA Specialist II-Operations

QA Specialist II
- Operations Location:

Location:

This position is based in our Portsmouth, NH office. This is a 1st shift position operating on a 12-hour rotating schedule (7:00 AM - 7:00 PM). The schedule follows a rotating pattern of Monday-Tuesday workdays, Wednesday-Thursday off, Friday-Sunday workdays
, and continues a biweekly rotation.

• 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.

• 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.

• 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

• 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 Track Wise, 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

• Effective communication, organizational, and time management skills with the ability to collaborate across Manufacturing, Quality, and support functions

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

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.