Stability Coordinator, Quality Control
The Quality Control Stability Coordinator is responsible for the management of stability programs to support the commercial programs at PaxVax.
- 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.
APPLY FOR THIS JOB
- 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