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Quality Control Manager - Vista, United States - Bachem
Description
A brief overview
The Manager of Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations within the Quality Control (QC) department.
This individual manages and executes coordination and successful stability testing; raw material qualification, testing, and release activities, as well as validation projects.
The QC Manager also coordinates testing to be performed by other QC personnel and by contract laboratories. Additionally, this individual supports the Director of QC in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the QC department.What you will do
Manage and oversee execution of QC testing including API, Raw material, validation, release, EM and microbial testing
Manage all method development activities, which include: Development and optimization of new and existing analytical methods for in process control and QC release/stability and microbial and environmental testing
Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
Establish and revise specifications and sampling plans for raw materials and final product
Develop and optimize of new and existing analytical methods for qualification and release testing
Coordinate stability program and the testing to meet stability endpoints, as needed
Manage 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 reoccurrences
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
Ability to work and communicate effectively with others within the company to ensure timely completion of tasks and projects
Qualifications
Bachelor's Degree with a minimum of 8 years industry experience
Master's Degree in Analytical Chemistry or related science field and a minimum of 5 years of Stability/Raw Materials testing and GMP/GLP experience (preferred)
PhD in Analytical Chemistry or related science field with 2 years industry experience (preferred)
At least 2 years management/supervisory experience in a GMP manufacturing facility
Extensive experience in GMP laboratory testing such as HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc.
Thorough knowledge and understanding of Analytical Chemistry, including USP materials testingCreativity 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
Our people are passionate about what they do, the product they sell, and the customers they serve.
If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.
Base Salary Range:
$97,128 - $133,551
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
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