QA Specialist II-Lot review

Lonza • Portsmouth, NH

1d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field
• 3–5+ years of experience in a GMP-regulated environment within Quality Assurance or related function
• Hands-on experience reviewing batch records and GMP documentation
• Strong understanding of cGMP and Good Documentation Practices (GDP)
• High attention to detail with a focus on accuracy and compliance
• Ability to identify discrepancies and follow through on resolution
• Strong organizational and time management skills
• Effective communication skills and ability to work cross-functionally
• Familiarity with data integrity principles and regulatory expectations

Nice To Haves

• Experience supporting audits or inspections is a plus

Responsibilities

• Perform detailed review of manufacturing batch records and supporting documentation for completeness, accuracy, and compliance
• Identify discrepancies, documentation errors, and GMP issues, and follow through to resolution
• Escalate complex or unclear issues to senior QA team members as appropriate
• Ensure all documentation aligns with Good Documentation Practices (GDP) and data integrity standards
• Support timely batch disposition activities through efficient and thorough review
• Participate in daily lot review/release meetings
• Maintain clear and accurate documentation of review findings
• Support audit and inspection readiness by ensuring records are complete and compliant
• Collaborate with manufacturing and quality teams to clarify and resolve documentation issues

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).
• Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What This Job Offers

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