Quality Assurance Specialist III

Employer
Bachem
Location
Vista, CA
Posted
Jul 22, 2021
Ref
695828101
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.

The Quality Specialist III fulfills a critical role for Central Function Quality Systems group. This individual will be responsible for assisting with the maintenance, user training and system administration of the MasterControl system at the Bachem Americas US sites. Additionally, this individual will be responsible for assisting in the implementation of new document types, routes, electronic forms or new MasterControl Solutions at Bachem. The incumbent will be responsible for trouble shooting and fixing MasterControl user issues. The incumbent will also assist with developing monthly metrics and issuing reports in order to assess the health of Bachem US quality systems.

Your Tasks:

  • Implement different aspects of MasterControl, such as new document types, workflows, eforms or Solutions (modules)
  • Perform user training to MasterControl modules
  • Perform internal audits on use of the MasterControl modules
  • Assist with harmonization of Quality Systems at US sites
  • Contribute to quality system improvements
  • Perform monthly metric reporting of QMS records
  • Assist with ad hoc CF-Q projects

Required:

  • Bachelor’s Degree in a science related field – Chemistry, Biology or equivalent
  • Minimum of 5 years’ experience in a FDA regulated industry: pharmaceutical, Medical Device, etc.
  • Experience in cGMP manufacturing, Quality Control, or Quality Assurance
  • Comprehensive knowledge of electronic Quality system management software (i.e. Trackwise, MasterControl, etc.). MasterControl experience optimal
  • Experience with MasterControl software as system administrator
  • Experience in configuring MasterControl software
  • Technical writing experience; writing SOPs, specifications and technical reports
  • Technically savvy
  • Excellent computer skills with emphasis on Microsoft Word, Excel and Access
  • Strong organizational skills
  • 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 technical and analytical problems
  • Ability to work independently and manage one’s time
  • Ability to function well in a team environment

Preferred:

  • Experience/involvement in validation of Quality Management system software i.e. drafting user requirement specification and executing test scripts