Manager / Sr. Manager, Quality Control

Bachem AG•Vista, CA

31d•$109,396 - $183,293

About The Position

The Manager / Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations. This individual is responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects. The Manager / Sr. Manager coordinates both in-house and contract laboratory testing activities. Additionally, this individual supports the Director, Quality Control in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the Quality Control department.

Requirements

Bachelor's degree in a relevant scientific field with a minimum of 8 years’ industry experience
4-6 years’ management experience
Extensive experience in GMP laboratory testing such as IPC, HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc.
Thorough knowledge and understanding of analytical chemistry, including USP materials testing
Creativity to solve technical and compliance problems
Comply with good housekeeping and safety practices
Experience in writing standard operating procedures (SOP’s) and test methods
Excellent written and oral communication skills
Excellent computer knowledge, including Microsoft Word, Excel, Power Point and Access
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one’s time
Ability to drive projects to success under time constraints
Communicate effectively and ability to function well in a team environment

Nice To Haves

Master's degree in a relevant scientific field with a minimum of 5 years’ industry experience (preferred)
PhD in a relevant scientific field with a minimum of 2 years’ industry experience (preferred)
1-3 years’ experience in managing projects (preferred)

Responsibilities

Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing
Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
Establish and revise specifications and sampling plans for IPC, raw materials and final product
Develop and optimize new and existing analytical methods for qualification and release testing
Coordinate stability program and the testing to meet stability endpoints, as needed
Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules
Write, review, and approve QC Standard Operating procedures (SOP’s) as needed
Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing
Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences
Manage external test laboratories for contract testing of raw materials and other related testing
Review test data for completeness and accuracy
Provide timely responses to internal and external inquiries
Stay abreast of new developments in analytical technologies
Contribute to improvements in laboratory operations to increase efficiency and GMP compliance