Section Manager, QC
1 month ago
Lonza is a global leader in life sciences, operating across three continents. We're looking for a talented individual to join our team as a Section Manager, QC. As a key member of our team, you will be responsible for supervising all testing techniques and scheduling of testing with coordinating with other departments to ensure timely delivery of results.
Key Responsibilities:- Supervise all microbiological and Environmental Monitoring techniques, including QC testing of environmental, raw materials, in-process, and final product samples.
- Responsible for tracking and review of virus and mycoplasma testing for all products (as required).
- Responsible for tracking and review of QC cell banking activities.
- Ensure that all personnel involved in testing are trained in basic cGMP training and are getting routine updates in cGMP information and training.
- Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications, and SOPs.
- Responsible for data and logbook review.
- Customer and regulatory agency interaction as required.
- Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance, and documentation issues are resolved.
- Evaluations of vendors via vendor audits, comprehensive testing, and review of quality performance.
- Perform report writing (Example: Deviations/Investigations/Trending).
- Involved in equipment qualification.
- Perform annual performance evaluations of all direct reports.
- Provide continued coaching and developing of subordinates to help them meet both their career and personal development goals and to ensure a cohesive, productive, and highly motivated team.
- To perform QC test as required.
- Degree in a relevant Science field or Equivalent.
- Substantial work experience, preferably lab experience in a biotech QC-related field.
- Supervisory experience, demonstrate solid leadership skill and ability to lead a team.
- Experienced in technology transfer, method transfer, and analytical method validation.
- Experienced in environmental monitoring of cleanrooms, aseptic process simulations, and microbiological tests such as bioburden, endotoxin, and sterility test.
- Good report writing skill and able to lead/author investigation report independently.
- Demonstrate troubleshooting and problem-solving skills.
- Demonstrate effective communication skill.
Lonza is committed to respecting and protecting our people and our environment. We strive to achieve our business results in an ethical manner. If you're passionate about improving lives and making a meaningful difference, join our team as a Section Manager, QC.
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