Quality Assurance Supervisor

United States, Greenwood (South Carolina)

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.

The Quality Assurance Supervisor will provide support to the Greenwood hard capsule operations for oversight of compliance and regulations. This position will provide the primary administration, reporting and oversight of major quality systems for the hard capsule site.

Key responsibilities:

  • All QA activities relating to finished product disposition and ensure compliance to master batch record. Ensuring orders are processed and approved or timely feedback.
  • Responsible for following up on all pending sampling, testing, and other quality checks , insuring investigations are complete and that all GMP documentation is correct and any errors.
  • Manage the collecting, maintaining, and archiving of the retained samples and batch records.
  • Assists departments on special requests and expediting orders when necessary; ensuring that all GMP’s are met during the batch record reviews.
  • Responsible for compiling and reporting monthly metrics related to quality systems.
  • Drive quality related metrics and improvements. Identify and implement potential improvement projects, as appropriate.
  • Work with internal departments to align on efficiency to meet compliance and business needs.
  • Lead departmental meeting to achieve compliance objectives/goals
  • Support functions needed for overall compliance needs, i.e., Food Safety Modernization Act (FSMA)
  • Support audits and respond to audit findings.  Host audits as needed as back-up.
  • Conduct internal audits and external supplier audits.
  • Assist in complaint investigations, and implementation of corrective actions.
  • Development of procedures and controls in support of the Quality Management System.
  • Coordinate CAPA/Deviation compliance
  • Coordinate Change Control

Key requirements:

  • Bachelors Degree in Business, Engineering, or Science related
  • PCQI, CQA, CQE certifications preferred
  • Manufacturing experience, a plus
  • Demonstrated interpersonal and communication skills
  • Demonstrated team building and leadership skills
  • Proficiency with Microsoft computer applications
  • Familiarity with basic statistics, SPC, and root cause analysis
  • Demonstrated experience using Six Sigma methodologies and tools, Belt preferred.
  • ASQ certification is also a plus.
  • Must have excellent written and verbal communications skills and be able to communicate to all levels of management effectively.
  • Must be able to work effectively in a team environment.
  • Demonstrated leadership experience
  • Formal Supervisory training is preferred

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: R33274