Senior QA Specialist - Operations
Lonza•Portsmouth, NH
•Onsite
About The Position
We are seeking a detail-oriented QA Operations Specialist to support batch record review and lot release activities within a cGMP manufacturing environment. This role is responsible for ensuring the accuracy, completeness, and compliance of production documentation while supporting cross-functional teams to meet quality and operational objectives. The ideal candidate will bring strong technical writing skills, GMP knowledge, and the ability to work independently while contributing to team success and continuous improvement initiatives.
Requirements
- Bachelor’s degree in a life sciences discipline or equivalent experience
- 5–10 years of experience in a cGMP-regulated environment within biotechnology or pharmaceutical manufacturing
- Strong understanding of GMP regulations (e.g., ICH, FDA) and good documentation practices
- Experience reviewing batch records, lot release documentation, and quality systems processes
- Strong attention to detail and critical thinking skills, with the ability to identify and resolve issues effectively
- Excellent written and verbal communication skills, with the ability to clearly present information and collaborate across teams
- Ability to manage multiple priorities, adapt to changing workloads, and escalate issues appropriately when needed
Nice To Haves
- Familiarity with systems such as TrackWise, SAP, or similar quality management systems preferred
Responsibilities
- Perform independent review and closure of manufacturing batch records and associated documentation to support product release
- Identify and assess discrepancies, non-conformances, and documentation issues, ensuring appropriate resolution in accordance with GMP requirements
- Participate in lot release meetings and coordinate documentation readiness to meet release timelines
- Apply knowledge of manufacturing processes and quality systems to support investigation and resolution of complex issues
- Guide and support junior QA staff on documentation review priorities and decision-making
- Ensure all deviations and quality events are appropriately documented, investigated, and closed
- Apply data integrity principles in all aspects of work, ensuring compliance with regulatory and company standards
- Contribute to continuous improvement initiatives and support daily quality operations as needed
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
