Lonza
QA Operations Specialist IV - LSA (Nightshift)
US - Portsmouth, NH
Sponsorship not specifiedDetected 21 days ago
SAPGMPCommunicationCollaborationMentoringMicrosoft Office
About the role
- QA Operations Specialist IV - LSA (Nightshift) Location: This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM - 7:00 AM).
- The schedule follows a rotating pattern of Monday-Tuesday workdays, Wednesday-Thursday off, Friday-Sunday workdays, and continues a biweekly rotation.
- This role serves as a key quality presence within operational areas, ensuring compliance, supporting decision-making, and driving high standards of GMP execution.
Requirements
- They have the ability to independently assess quality issues and triage the majority of issues but also escalate to Senior management when appropriate.
- Bachelor's degree in life sciences discipline or equivalent experience
- 8+ years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment
- Strong understanding of cGMP, ICH guidelines, and quality systems
- Working knowledge of manufacturing operations, including upstream/downstream processes, QC, or related functions
- Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications
- Ability to independently assess quality issues, make sound decisions, and appropriately escalate complex situations
- Strong communication and interpersonal skills, with the ability to provide clear guidance and influence GMP behaviors on the shop floor
Nice to have
- Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment preferred
Compensation
- Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- Life insurance, as well as short-term and long-term disability insurance.
- Paid time off (PTO).
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.