QA Supervisor - Batch Release

United States, Hayward (California)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

QA Supervisor - Batch Release

This role is critical to the site in providing leadership to the Quality Batch Release team. The team is responsible for providing quality manufacturing oversight on the production floor and review of all documentation.

Key responsibilities:

  • Ensure timely Quality release of products by managing a team in the review of documentation to verify compliance to GMPs, SOPs and regulatory requirements.
  • Plans and schedules the work of QA Specialist
  • Write, revise, and review SOPs.
  • Oversee QA on the floor activities (e.g. review, verifications, inspections, etc.)
  • Ensure quality and consistency in documentation and adherence to SOPs.
  • Maintain expertise in quality systems (e.g. change control, deviation, etc) and ability to initiate and execute quality records.
  • Assist with continuous improvement initiatives / projects.
  • Participate in internal or external audits as an SME for Batch Release, and support audit observations as needed.
  • Ensure training requirements are met and records are up to date for self and team.
  • Maintain and update departmental metrics and reporting.
  • Work closely with the Manufacturing department to provide on-going Quality support.
  • Represent QA at cross-functional meetings, providing QA input and decision making.
  • Provide training to group and departments when needed
  • Work with department manager to identify and drive improvement opportunities. Skill and knowledge with lean manufacturing tools and six sigma methodologies necessary to analyze and improve business processes.
  • Work closely with Production Supervision, Quality, and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications and test methods.
  • Hires, trains and evaluates all personnel. Makes wage and salary recommendations and maintains performance records.  Provides team members with coaching and feedback

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement 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.

Reference: R22708