Quality Control Scientist II/III

Location
Berkeley, California
Posted
Mar 23, 2018
Ref
18-022N
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Perform Quality Control activities in collaboration with his/her peers in support of project deliverables, including but not limited to performing scientifically sound data analyses to draw conclusions regarding analytical method performance, equipment functionality, product stability and the like, manage the work schedule of QC analysts, ensure that the QC laboratory is in compliance with FDA and EU regulations, and perform development studies.

Responsibilities
  • Manage Quality Control (QC) testing schedule of cGMP manufactured drug substance, drug product and in-process samples by following written procedures, in support of lot release and stability.
  • Use good documentation practices to record original test data and data analysis.
  • Perform peer review (technical and compliance) of data generated by other QC team members.
  • Troubleshoot and provide resolutions for invalid physical/chemical based assays (HPLC, UV-Vis, plate reader, osmolality, etc.).
  • Perform deviation, OOS and OOT investigations and provide corrective and/or preventative actions.
  • Design laboratory experiments to support deviation investigations, method optimization, method transfer and/or method validation of QC test methods following cGMP regulations.
  • Write study protocols and reports, providing scientifically sound experimental design and data analysis.
  • Provide technical guidance and support to the QC team for the onboarding of new equipment and technology.
  • Work with cross functional teams to implement regulation compliance improvement measures and to enhance QC workflow efficiency.
  • Perform development studies with cross-functional project teams.
  • Spend approximately 50% of the time in the laboratory.
  • Work as a member of a fully-integrated team.
  • Support the organization in maintaining a work environment focused on quality and that fosters respect, learning, open communication, collaboration, integration, and teamwork.
Other duties as assigned

Qualifications
  • PhD in chemistry, biochemistry, or other related science with f 3 to 5 years’ related industry experience in Quality Control and/or Analytical Development for the Scientist II. The Scientist III will have 5 to 8 years’ of related experience. 
  • Hands-on RP-HPLC experience, with demonstrated ability to troubleshoot the HPLC method and equipment.
  • Must possess knowledge and experience in statistical data analysis.
  • Must have intermediate to advanced knowledge of Microsoft Excel, Word and statistical software such as Minitab.
  • Documented cGMP training from a recognized source.
  • Strong analytical, technical writing, communication and data management skills are required.
  • A self-starter who is flexible, as well as action and goal-oriented.
  • Must have the aptitude to apply critical thinking and effective problem-solving skills.
  • Enjoys a fast-paced, team-oriented, and collaborative environment.
Additional knowledge and skills desired, but not required:

  • A BS or MS with 12+ years direct experience in Quality Control and Analytical Development in lieu of a PhD may be considered.
  • Experience with a variety of chemical/physical laboratory instruments is a plus (mass spectrometry (MS), dynamic light scattering (DLS), capillary electrophoresis (CE), and the like).
  • Experience with laboratory audits.
  • Experience with Deviations, CAPAs and Change Controls in a cGMP environment.
  • Experience with equipment qualification in a cGMP environment.
Knowledge and experience with GLP regulations.