QA Specialist II

United States, Hayward (California)

Today, Lonza is a global leader in life sciences operating across three 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.

QA Operations Specialist II is responsible for the review and approval of GMP documentation to ensure compliance in operational areas. Through their fundamental knowledge, assists manufacturing associates by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities. Participates in deviations and root cause investigations. Focused responsibilities include batch record review, execution of QA walkthroughs, removal of Quality Out-of-service Tags, approval of suite change-overs and line clearance and review of QA Operations related SOPs to meet local, Global and Regulatory requirements.

Key Responsibilities:

  • Review and approve GMP documentation against Standard Operations Procedures to ensure manufacturing steps are appropriately documented, observations are clear, and Good Documentation Practices are followed. 
  • Conduct QA walkthroughs on the manufacturing floor for detection of non-compliance issues, inspection risks, and procedural or GMP non-compliances. Perform assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
  • Approve manufacturing suite change-overs, and line clearance activities. Verify release requirements for areas and equipment, and remove Out-of-service tags.
  • Identify areas of non-conformance. Complete minor deviations and support root cause investigations. 
  • Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
  • Co-represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.
  • Perform other duties as assigned.   

Key requirements:

  • Excellent written and verbal communication skills
  • Must have attention to detail and good investigation, problem solving and organizational skills
  • Ability to work effectively with people and communicate negative information and obtain positive results
  • Works well and facilitates positive interdepartmental interactions with a diverse group of people.  Voluntarily communicates needs and suggestions clearly and effectively.  Listens and is attentive to others
  • Familiarity with SAP, TrackWise, DMS, and LIMS systems an advantage
  • Capable of being flexible as required tasks change and maintain productivity
  • Keeps project leads and team members informed of the status of assigned work
  • Must be a strong, dependable team player
  • Ability to work with Microsoft Office applications
  • Resolve differing perspectives with effective negotiation skills

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.

Reference: R41798