Manager / Sr. Manager, Quality Control - Microbiology

Bachem AG-posted 5 days ago
$109,396 - $183,293/Yr
Full-time • Mid Level
Vista, CA
11-50 employees
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The Manager / Sr. Manager, Quality Control - Microbiology 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.

  • 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
  • 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
  • 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)
  • competitive pay
  • annual performance bonus
  • a generous benefit package with comprehensive Medical/Dental/Vision coverage
  • 401(k) plan with employer contribution
  • paid vacation, personal and sick days
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