QC Analytical Chemist Manager

Cupertino, CA | Direct Hire

Post Date: 05/08/2017 Job ID: 11147 Industry: Clinical & Scientific

Bayside Solutions is seeking a QC Analytical Chemist Manager to join our partner’ s team in the San Francisco South Bay Area. This is an opportunity for candidates with HPLC method development and a passion for documentation in a GMP/FDA regulated environment to oversee two QC Chemists.

Our partner’ s culture is professional and hard working. They foster longevity and stability within their organization.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

QC Analytical Chemist Manager

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases
  • Work for a company that is local to the bay area and recognized as a leader of innovation
  • Competitive compensation commensurate with experience
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K

Summary of Responsibilities:
  • Supervise two QC Chemist’ s laboratory notebook and ensure data is in compliance with GMP/FDA regulations.
  • Interact with R&D and Quality department personnel.
  • Analyze GMP data, investigate and resolve issues.
  • Write, review, revise and approve Quality Specifications, SOP’ s, test method validation protocols, reports and technical reports as needed.
  • Leads investigations of laboratory deviations and OOS results.
  • Review documentation of equipment pertaining to IQ/OQ/PQ calibration.
  • Maintain relationships with outside contract labs as needed for QC testing needs.
  • Stability chamber maintenance and Labwatch administrator.
  • QC representative for department during QC lab audit.
  • 10% laboratory work on an as needed basis.

 

Required Qualifications:
  • BS/MS in Chemistry, Pharmaceutics, or other Life Science related field mandatory.
  • 5 years’ experience in a biopharma GMP/FDA regulated environment.
  • HPLC analytical method development.
  • Detail oriented.
  • Strong interpersonal skills.
  • Strong passion for writing and documentation.

 

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