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Manager / Sr. Manager, Quality Control

Bachem

Vista, USA

Manager · 1–3 years experience

USD 109396-164095 / year

Discovered 1 weeks ago

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What you will do

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

Qualifications

Bachelor's degree in a relevant scientific field with a minimum of 8 years’ industry experience
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’ management experience (preferred)
1-3 years’ experience in managing projects (preferred)

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Manager / Sr. Manager, Quality Control

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Key Skills for This Role

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What you will do

Qualifications

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