Hybrid Quality Control Manager

Posted 3 weeks ago

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About the role

  • Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner
  • Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results
  • Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages
  • Submitting test packages to QA for their review and loading all data into the electronic storage program
  • Review of analytical data related to reference standard qualification, method validation and method transfer activities
  • Travel, when necessary, to analytical testing sites or other sites
  • Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
  • Create or review BBio Standard Operating Procedures as it pertains to Quality Control or management of contract analytical laboratories

Requirements

  • M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred
  • 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP)
  • 2+ years management experience
  • Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
  • Proven abilities in leadership and personnel management
  • Strong oral and written communication skills
  • Excellent organizational and planning skills and high attention to detail
  • Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines
  • Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities

Benefits

  • Market leading compensation
  • 401K with 100% employer match on first 3% & 50% on the next 2%
  • Employee stock purchase program
  • Pre-tax commuter benefits
  • Referral program with $2,500 award for hired referrals
  • Comprehensive health care with 100% premiums covered - no cost to you and dependents
  • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
  • Hybrid work model - employees have the autonomy in where and how they do their work
  • Unlimited flexible paid time off - take the time that you need
  • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
  • Flex spending accounts & company-provided group term life & disability
  • Subsidized lunch via Forkable on days worked from our office

Job title

Quality Control Manager

Job type

Experience level

Mid levelSenior

Salary

$120,000 - $150,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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