QC Supervisor

Employer
Bachem
Location
Vista, CA, US
Posted
Dec 18, 2020
Ref
638347201
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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