QA Specialist III-Lot Review

Lonza•Portsmouth, NH

10d•Onsite

About The Position

Join our Quality Assurance team in Portsmouth, NH, where you’ll play a critical role in ensuring the integrity and compliance of our manufacturing processes. This is an exciting opportunity to contribute to the release of life-changing therapies while developing your skills in a collaborative environment. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance Medical, dental, and vision insurance Opportunities for professional growth and leadership development Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits

Requirements

Bachelor’s degree in Science or related field
5–10 years of experience in cGMP environments
Strong knowledge of quality systems and good documentation practices
Excellent attention to detail and critical thinking skills
Effective written and verbal communication skills
Ability to work independently and within a team environment
Proficiency in Microsoft Office

Nice To Haves

experience with Trackwise and SAP preferred

Responsibilities

Review and close manufacturing batch records and related documentation for API release
Resolve issues and escalate complex cases when needed
Participate in daily lot release meetings and routine QA activities
Train junior staff on record review processes
Apply data integrity principles in all aspects of work
Support process improvement projects and quality initiatives
Collaborate with QA, QC, and Manufacturing teams to maintain compliance