Stability Coordinator, Quality Control

Department
Quality Control

Location
San Diego

Summary Description
The Quality Control Stability Coordinator is responsible for the management of stability programs to support the commercial programs at PaxVax.

Specific Responsibilities:

  • Authors stability protocols and reports.
  • Authors IND and annual report stability sections.
  • Recommends new stability programs for products in compliance with ICH guidelines.
  • Schedules and coordinates the pulling of all stability samples with the QC laboratory.
  • Reviews analytical data for completeness and trending.
  • Complies stability data for trending, reporting, and archiving.
  • Aids in the outsourcing of stability samples to contract laboratories for testing.
  • Aids in OOS and OOT investigations and recommends corrective actions.
  • Performs trends analysis and presents to key departments.
  • Responsible for transfer of paper-based stability program to LIMS system.
  • Other responsibilities, as required.

Requirements:

  • Bachelor’s/Master’s degree in biology, chemistry, or similar discipline and 5 to 10 years of experience working with pharmaceuticals or biologics/ biopharmaceuticals.
  • Minimum 3 years of experience managing stability programs.
  • Demonstrated experience analyzing critical data and proactively solving problems.
  • Experience with statistical applications for stability data evaluation and shelf-life determination (e.g. JmP).
  • Proven experience with various quality processes (e.g. investigations/ deviations, CAPAs, change controls, etc.).
  • Excellent working knowledge of GMP regulations for stability programs and laboratory applications.
  • Good understanding of regulatory requirements, including ICH, USP/ EP, FDA/ EMA.
  • Experience drafting stability sections of INDs, NDA/ BLAs, and other regulatory documents.
  • Possess a strong work ethic along with a solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills.
  • Demonstrated experience working independently, quickly, and flexibly with scheduling.
  • Strong leadership experience
  • Ability to work independently and manage projects in a timely manner.
  • Strong interpersonal skills.
  • Excellent verbal and written communication skills.
  • Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity
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