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Bachem · 1 month ago

Manager / Sr. Manager, Quality Control

Vista, CA

Full-time

Onsite

Senior Level, Lead/Staff

$109K/yr - $183K/yr

8+ years exp

Bachem is a company specializing in active pharmaceutical ingredient manufacturing. The Manager / Sr. Manager, Quality Control is responsible for managing stability testing, raw material qualification, and overseeing QC testing activities while supporting the Director of Quality Control.

Chemical

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

Qualification

GMP laboratory testingAnalytical chemistryProject managementStandard Operating Procedures (SOPs)Analytical methods developmentCommunication skillsDetail orientedProblem solvingTeam collaborationTime management

Required

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