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QC Scientist II BSD

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

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

Your Responsibilities

The QC Scientist II performs laboratory day-today operations, guides and interacts with QC and

department personnel to accomplish goals and objectives as directed by supervisor.  Other duties

include performing raw material testing, final product testing, QC documentation and related GMP

activities.

 

Your Tasks

  • Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
  • Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
  • Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor
  • 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
  • Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
  • Receive, test and release final product peptide manufactured at Bachem
  • Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
  • Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
  • Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
  • Write standard operating procedures, standard test procedures and other related GMP documentation
  • Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
  • Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, 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 as necessary to include but not limited to analytical work, documentation and quality GMP procedures
     

 

Your Profile

 

  • Bachelor’s Degree in Chemistry or related field
  • Minimum of 5 years’ experience in the GMP industry
  • Use of analytical techniques/ instruments, such as, HPLC, GC, etc. and computer skills
  • 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
  • Ability to review Certificate of Analysis for Reagents for the creation of specification documents
  • Organization skills to support the department in the creation and approval of controlled documents in a timely manner
  • Flexibility of working hours based on business needs, may include some nights and occasional weekends

 

Preferred:

  • Experience with Peptides
  • Technical writing experience
  • Master’s degree in Chemistry or related field
  • Experience with Equipment Maintenance Programs

 

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