Quality Assurance Specialist III

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 III 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

  • GMP compliance improvements
  • Perform GMP audits for internal operations as needed
  • Work closely with other functions to close out deviations, CAPA and product complaints
  • Provide cGMP compliance guidance to other departments
  • Writing new and revising current standard operating procedures (SOPs), specifications, etc.
  • Reviewing all GMP documentation, including BPRs and monitoring data
  • Reviewing trending data
  • Provide support to customer and regulatory audits
  • Recommends and implements new policies and procedures to improve existingprocesses and products
  • Writing and reviewing validation protocols, reports and master plans
  • Problem resolutions with GMP systems

Your Profile

  • A Bachelor’s Degree in Chemistry,Biochemistry or other Life Scienceand a minimum of 5 years’ experience in the GMP / Manufacturing setting.
  • 5 years’ work experience in GMP manufacturing
  • Experience in GMP manufacturing environment, Quality Assurance and Quality Control
  • Experience with GMP document control, validation, qualification and calibration
  • Experience with Batch release.
  • 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