QC Specialist IV - Stability

Lonza•Portsmouth, NH

13d•Onsite

About The Position

QC Specialist IV - Stability Location: Portsmouth, NH. The shift schedule is from 7:00 am-3:30 pm (Monday to Friday). The QC Specialist IV operates as a skilled professional, utilizing judgment and initiative to solve complex problems and improve processes in compliance with company policies. This role involves analyzing data, conducting in-depth evaluations, and acting as the stability representative at Analytical Project Team meetings. Additionally, the Specialist IV interfaces directly with customers and provides leadership by acting as a group lead in the absence of the area manager. Overall, this position requires technical expertise, meticulous documentation, and the ability to lead daily opera tions. What you will get: Competitive salary and comprehensive benefits package. Opportunities for career development and advancement. Supportive and collaborative team environment. Access to cutting-edge technology and tools. Commitment to employee well-being and safety. Inclusive workplace culture. Recognition and reward for your contributions. Access to our full list of global benefits: https://www.lonza.com/careers/benefits

Requirements

Bachelor's degree in a Life Science field of study. A combination of education and years of experience will be considered.
5-10 years of experience in a laboratory setting; preferred in Stability or Quality Control.
Exhibit strong judgment and data interpretation skills to tackle complex tasks and solve problems within established procedures.
Maintain a consistent presence by working full shifts and ensuring all assignments are completed accurately and on schedule.
Demonstrate high-level written and verbal skills to share information clearly and professionally.
Act as a self-motivated player who fosters a positive environment and builds strong professional relationships.
Committed to quality and accountability through effective task prioritization, project planning, and minimal re-wor k.

Responsibilities

Author and review GMP-compliant documentation, specifically focusing on stability protocols, reports, and process change controls.
Oversee the full lifecycle of stability studies , including sample tracking, pulls, and shipments to external contract labs or customers.
Manage deviations , laboratory investigation reports, and ensure all work adheres strictly to Data Integrity principles.
Serve as the stability lead in customer project teams, managing communications with partners and internal departments like MFG and QA.
Drive audit readiness by conducting lab walkthroughs and acting as a Subject Matter Expert (SME) during regulatory inspections.
Provide coaching and feedback to junior staff as a qualified trainer to improve team compliance and technical skills.
Proactively identify process improvements (e.g., 6S) and delegate daily tasks to ensure operational targets are met accurately and on time.