Supervisor, Quality Control

Employer
Bachem
Location
Vista, CA
Posted
Sep 23, 2021
Ref
695894001
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

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.