QC Scientist III FM BSD

Employer
Bachem
Location
Vista, CA, US
Posted
Oct 15, 2020
Ref
609381101
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time


Your Responsibilities

The Quality Control Scientist III function is to perform laboratory day-today operations, guide and

i interact with QC and department personnel to accomplish goals and objectives as directed by the

Director of Quality Control. Other duties include performing in-process testing, GC method validation,

raw material testing, and final product testing, QC documentation and related GMP activities.

Your Tasks
  • Maintain and perform daily operations of the QC department on a daily basis in coordination with the QC Director to include testing of in-process, raw material/peptide samples and prioritizing projects
  • Implement and maintain GMP procedures such as following SOP's, Standard Testing Procedures (STP's), written procedure and maintaining proper documentation as necessary for Quality Control
  • Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
  • Test and release in-process, and raw materials used in the manufacturing facility for GMP. Performing analytical testing and reviewing data for completeness and accuracy. Support method validation activities for in-process samples.
  • Receive, test and release final product peptide manufactured at Bachem
  • Write/revise specifications as necessary, performing analytical testing and reviewing data for completeness and accuracy
  • Write standard operating procedures, standard test procedures and other related GMP documentation
  • Perform QC analysis to include: GC, HPLC, Water, Mass Spec, UV, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related
  • analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods
  • Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
  • Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor
  • Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility
  • Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
  • Support validation, and stability testing activities as needed, documentation and quality GMP procedures



Your Profile
  • BS Degree in Chemistry or related field
  • Minimum of 8 years' experience in the GMP industry
  • Experience with the use of analytical techniques/ instruments, such as, Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Karl Fischer (KF), etc.
  • May work with hazardous materials and chemicals
  • Ability to train others in analytical methodology
  • Ability to take the technical lead working with other scientists
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
  • 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
  • May involve second shift testing activities
  • Flexibility of working hours based on business needs, may include some nights and occasional weekends


Preferred:
  • Experience with Peptides
  • Master's degree in Chemistry or related field
  • Experience with use of Master Control



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