Quality Assurance Specialist II

Vista, CA
Jun 23, 2022
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 Quality Assurance Specialist II fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training.

Your Tasks

  • Review validation protocols, data and reports, as assigned
  • Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls
  • Perform annual product quality reviews and system reviews as assigned
  • Review raw material records
  • Provide support to customer and regulatory audits.
  • Conduct internal audits as assigned
  • Implement improvements in quality systems and SOPs
  • Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control
  • Provide technical assistance on all production & quality systems documents
  • Organize and update document room files as required
  • Assist with ad hoc QA projects and other duties as assigned

Your Profile

  • A Bachelor’s Degree inChemistry or Biochemistryand a minimum of 3 years’ experience in the GMP / Manufacturing setting
  • 3 years’ work experience in GMP manufacturing
  • Experience in GMP manufacturing, Quality Assurance and/or Quality Control
  • Experience with GMP document control, validation, qualification and calibration
  • Ability to work in ISO7 and ISO8 control environment and support real time batch record review
  • Experience in internal auditing as well as working with regulatory agencies
  • 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

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.U.S. employees of Bachem Americas, Inc.