Lonza
QC Specialist II-Stability
US - Portsmouth, NH · Mid
Sponsorship not specifiedDetected 20 days ago
GMPCommunicationCollaborationMentoringOrganizational Skills
About the role
- QC Specialist II-Stability Location: This position is based in our Portsmouth, NH office.
- The typical work schedule is Monday through Friday, 7:00 AM-4:00 PM EST.
- With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow.
Responsibilities
- This role supports GMP-compliant stability programs through study setup, sample management, testing coordination, data tracking, and report generation.
- As a senior-level specialist, this position requires strong technical expertise, sound judgment, and the ability to independently manage moderately complex assignments.
- Manage and execute GMP stability studies within the QC laboratory
- Create, review, and revise GMP documentation including protocols, reports, deviations, and change controls
- Support laboratory investigations and process change activities
- Maintain compliance with Data Integrity and GMP requirements
- Drive audit readiness activities and support inspections as a subject matter expert (SME)
- Delegate tasks and support daily laboratory operations
- Identify and implement process improvements and operational efficiencies
- Working knowledge of aseptic techniques and GMP laboratory practices, with the ability to maintain sample integrity and compliance within a controlled laboratory environment
Requirements
- Strong understanding of GMP regulations, Data Integrity principles, and quality compliance expectations, with the ability to consistently apply them in daily laboratory operations
- Proven ability to interpret and analyze data, prioritize multiple assignments, solve problems effectively, and make sound decisions in a fast-paced laboratory environment
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).
Company info
- The QC Specialist II serves as the primary Stability representative on Analytical Project Teams and works directly with customers, contract laboratories, and internal cross-functional teams.
- Perform stability pulls and coordinate shipment of samples to customers and contract labs
- Communicate effectively with customers, business partners, and internal departments
- What we are looking for:
- Excellent written and verbal communication skills, with the ability to effectively communicate with customers, business partners, and cross-functional internal teams
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.