QC Supervisor
- Employer
- Bachem
- Location
- Vista, CA, US
- Start date
- Jan 16, 2021
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach
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Your Responsibilities
The supervisor 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 testing for raw materials, IPC, Final product and Microbial testing. 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.
Your Tasks
Manage and execute testing for all type of QC samples for use in manufacturing
Supervise QC scientists and oversee the testing process in the lab
Have a good understanding of optimization of new and existing analytical methods for qualification and release testing.
Write, review, and approve QC Standard Operating procedures (SOP's) as needed
Oversee QC lab equipment qualification and ensure the lab is maintained in a compliant manner consistently.
Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, environmental, and water testing
Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel who contribute to testing.
Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent reoccurrences
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
Your Profile
Bachelor's Degree with a minimum of 3 years extensive industry experience.
Thorough knowledge and understanding of Analytical Chemistry, including USP materials testing
Experience in GMP laboratory testing such as UPLC/ HPLC, GC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, TOC, etc.
Comply with good housekeeping and safety practices
Excellent written and oral communication skills. Experience in writing standard operating procedures (SOP's) and test methods
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
Communicate effectively and ability to function well in a team environment
Preferred:
Bachelor or Master's Degree in Analytical Chemistry or related science field and a minimum of 2 years of QC testing and GMP/GLP experience
We Offer
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are
looking for a new challenge and want to join a motivated team in an internationally renowned company,
you should seize this opportunity.
Nearest Major Market: San Diego
The supervisor 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 testing for raw materials, IPC, Final product and Microbial testing. 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.
Your Tasks
Manage and execute testing for all type of QC samples for use in manufacturing
Supervise QC scientists and oversee the testing process in the lab
Have a good understanding of optimization of new and existing analytical methods for qualification and release testing.
Write, review, and approve QC Standard Operating procedures (SOP's) as needed
Oversee QC lab equipment qualification and ensure the lab is maintained in a compliant manner consistently.
Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, environmental, and water testing
Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel who contribute to testing.
Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent reoccurrences
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
Your Profile
Bachelor's Degree with a minimum of 3 years extensive industry experience.
Thorough knowledge and understanding of Analytical Chemistry, including USP materials testing
Experience in GMP laboratory testing such as UPLC/ HPLC, GC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, TOC, etc.
Comply with good housekeeping and safety practices
Excellent written and oral communication skills. Experience in writing standard operating procedures (SOP's) and test methods
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
Communicate effectively and ability to function well in a team environment
Preferred:
Bachelor or Master's Degree in Analytical Chemistry or related science field and a minimum of 2 years of QC testing and GMP/GLP experience
We Offer
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are
looking for a new challenge and want to join a motivated team in an internationally renowned company,
you should seize this opportunity.
Nearest Major Market: San Diego
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