Bachem

Manager – Quality Control

Bachem

full-time

Posted on:

Location Type: Office

Location: San Diego • California • United States

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Salary

💰 $109,396 - $183,293 per year

Job Level

Senior

About the role

  • 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

Requirements

  • 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)
  • 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
Benefits
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP laboratory testingIPCHPLCGCTLCUV-VIS SpectrophotometerKarl Fisher TitratorFTIRMSLAL
Soft Skills
creativityexcellent written communicationexcellent oral communicationorganizational skillsmultitaskingproblem-solvingindependencetime managementteamworkproactive communication