Quality Assurance (Biotech)

  • Gaithersburg, MD
  • $85,000 - $105,000
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A bit about us:

Based in Gaithersburg, MD we are a clinical stage biopharmaceutical company focused on developing liver disease and immune modulating therapies. We are looking for a Quality Assurance (Biotech) to join our growing team!

Why join us?

  • Competitive Salary!
  • Great Benefits Package!
  • The Opportunity to Join an Amazing Team!

Job Details

  • Bachelor of Science degree or higher in a scientific discipline is required.
  • A minimum of 5 (five) years of GMP quality assurance experience in biopharmaceutical industry is required.
  • Demonstrate a solid understanding of biologics manufacturing – process, analytical operations, quality systems and regulations.
  • Direct experience with document management, SOP development, batch record review and product disposition are required.
  • Experience in GMP/GLP record review, investigations, change control, validation and risk assessment.
  • Ability to build strong collaborative relationships with partners in and outside of the organization.
  • Experience with providing direct oversight and support to clinical material manufacturing operations is highly preferred.
  • Experience performing deviation investigations including CAPA planning and management is highly preferred.
  • Proficient use of MS PowerPoint, Excel and Word.


Easy Apply Now
Easy Apply Now
Job Details
Location
Gaithersburg, MD
Job Type
Permanent
Compensation
$85,000 - $105,000