QA Specialist II-Lot review

QA Specialist II – Lot ReviewLocation: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.What you will get: Below you will find a comprehensive summary of the benefits package we offer: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.What you will do:The QA Specialist II – Lot Review is responsible for supporting the accurate and timely review of manufacturing batch records and associated documentation to ensure compliance with GMP and regulatory requirements. This role is highly detail-oriented and focused on the execution of batch record review and documentation accuracy.Perform detailed review of manufacturing batch records and supporting documentation for completeness, accuracy, and complianceIdentify discrepancies, documentation errors, and GMP issues, and follow through to resolutionEscalate complex or unclear issues to senior QA team members as appropriateEnsure all documentation aligns with Good Documentation Practices (GDP) and data integrity standardsSupport timely batch disposition activities through efficient and thorough reviewParticipate in daily lot review/release meetingsMaintain clear and accurate documentation of review findingsSupport audit and inspection readiness by ensuring records are complete and compliantCollaborate with manufacturing and quality teams to clarify and resolve documentation issuesWhat we are looking for:Bachelor’s degree in Life Sciences, Engineering, or a related field3–5+ years of experience in a GMP-regulated environment within Quality Assurance or related functionHands-on experience reviewing batch records and GMP documentationStrong understanding of cGMP and Good Documentation Practices (GDP)High attention to detail with a focus on accuracy and complianceAbility to identify discrepancies and follow through on resolutionStrong organizational and time management skillsEffective communication skills and ability to work cross-functionallyFamiliarity with data integrity principles and regulatory expectationsExperience supporting audits or inspections is a plusAbout LonzaAt 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.Ready to shape the future of life sciences? Apply now.SummaryLocation: US - Portsmouth, NHType: Full time