QC Stability Specialist III (Biotech)

 

Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents.' While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Location: Portsmouth, NH Hybrid

Work Hours: Monday-Friday 0700 - 1530

Job Summary:

The QC Stability Specialists are responsible for the management and execution of stability studies in the Quality Control Laboratory. Set up stability studies, perform stability pulls, track stability testing, ship samples to contract labs and create stability reports. A QC Specialist III: Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex tasks in creative and effective ways. Works on assignments that are moderately complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. Works on moderately complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Acts as QC Stability representative at Analytical Project Team meetings and interfaces directly with customers.

Key Responsibilities:

· Creation, revision and review of GMP documentation including stability protocols and reports.

· Participate in customer project teams as the stability representative. Verbal and written communication with customers and business partners.

· Initiation and completion of necessary process change controls, deviations and laboratory investigation reports.

· Track stability samples and coordination with testing laboratories.

· Set up stability studies, perform stability pulls and shipments of stability samples to customers and contract labs.

· Provides mentorship, coaching and feedback to junior specialists. Offers guidance to co-workers with respect to compliance.

· Delegates tasks to support daily operations.

· Qualified trainer, able to train team members using first-hand experience of successes and failures to coach others during training.

· Identifies areas of improvement and works to implement them (i.e. 6S, document revisions, workorders).

· Communicates to other departments as appropriate (MFG, QA, MSAT, etc.) during operations and escalate issues as needed.

· Drives audit readiness on the team. Conduct Pre-Audit walks through the laboratory space. Can provide SME discussions during audits.

· Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures

· Completes assigned tasks on-time and accurately, can identify needed tasks and complete without direction.

· Perform other duties as assigned.

Key Requirements:

Associate's degree in a Life Science field of study. A combination of education and years of experience will be considered.

Experience in a laboratory setting preferred; preferred in Stability or Quality Control

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law