Supervise the QC Chemistry Department in agreement with all regulatory requirements. Drive quality improvements of products and processes through active participation in interdepartmental areas. Supervise the QC Chemistry laboratory for in-process, finished product, customer complaint and stability samples for all products manufactured at Bausch + Lomb. Assume the responsibility for the GMP, ISO and Environmental Health and Safety procedure awareness and compliance within the respective areas. Primary back-up for QC Chemistry Lab Manager.
1. Responsible for the supervision and development of all personnel within the QC Chemistry.
2. Responsible for the GMP compliance of all functions and processes of the QC Chemistry department and drive continuous improvement.
3. Back-up role in the transfer of analytical methods and specifications from new products from R&D and CM to QC Chemistry.
4. Provide analytical testing expertise including oversight and guidance for site engineering, R&D and CM projects and investigations.
5. Project Management for QC Chemistry departmental projects.
6. Review, generation and approval of analytical investigations (LIRs) and non-conformances (NCs).
7. Responsible for the compliance of the supervised individuals to the company training policies for the QC Chemistry Department.
8. Evaluate and upgrade lab equipment, instruments and software, capacity and efficiency.
9. Review/approve validation and qualification protocols. Write/review/approve SOPs.
10. Engage team to identify and implement actions to improve on-time delivery, improve right first time, and improve process efficiency.
11. Assume the responsibility for the GMP, ISO and Environmental Health and Safety procedure awareness and compliance within the respective area.
Education: BS or MS degree in Chemistry / Biology or related scientific discipline.
Experience: 7-10 years of laboratory work experience of which at least 3-5 years must be in the supervisory role.
Skills: Must have demonstrated expertise and knowledge of laboratory equipment, Method Development, validation and tech transfer.
Other Skills: Must be able to work and solve problems independently as well as part of a team. Able to take on additional duties as required in the team environment. Should have a working knowledge of MS Word and MS Excel.