Search Jobs

Snr Quality Assurance Specialist

Edison-New Brunswick Metro Area, NJ

Posted: 07/24/2019 Job Type: Scientific Job Number: JN -072019-25267
Position Scope:
  • Responsible for establishing microbiological policy requirements, and processes for compounds in development.
  • Responsible for providing SME oversight and expertise associated with microbiological aspects in testing, manufacturing operations and deviation/investigation resolution for all company products.
  • Is the main contact for regulatory agency inspections (FDA, EMEA, MHRA, etc.) associated with microbiological inquiries for compounds in development.
  • Must be a technical/scientific expert in microbiology as it relates to pharmaceuticals. Must be able to measure technical/scientific attributes in qualitative ways and drive science-based decisions across the organization.
  • 5-8 years of experience in biological/small molecule product quality assurance and/or manufacturing, with working knowledge microbiology, and virology techniques
  • Thorough knowledge of cGMP in the pharmaceutical and biologics industries.

Skills/Knowledge Required:
  • Bachelors, Masters, or Ph.D. (higher degree preferred) in a microbiological science. 5+ (Ph.D.), 8+ (Masters) or 10+ (Bachelors) years of experience in microbiology for compounds in development.
  • Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time.
  • Minimal supervision and ability to contribute in a team environment. Able to communicate results and issues effectively, both written and orally. Knowledgeable in Microsoft Office, with an emphasis in MS Word and Excel.
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.