Quality Control Research Associate - III
About The Position
We are seeking a highly motivated Sr. Quality Control (QC) Specialist to support the Product Quality function. The role is located in California and reports to the Director of Analytical Method Lifecycle and Trending, while working cross-functionally with global and site-based QC subject matter experts and other Technical Operations departments. The position is initially based in Santa Monica for November, includes some remote work, and then returns to the Thousand Oaks office. The stated onsite schedule is three collaboration days per week: Tuesday, Wednesday, and Thursday. The assignment duration is 10 months.
Requirements
- One of the following education and experience combinations: a master's degree and 4 years of experience in a Quality function in the pharmaceutical or biotechnology industry; a bachelor's degree and 6 years of such experience; or a high school degree and 10 years of such experience.
- Proficiency with statistical tools such as JMP and/or Minitab.
- Proficiency with Microsoft Office applications.
- Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11 and 21 CFR Parts 210/211.
- Knowledge of Quality Control, GMPs, and GLP.
- Strong written and oral communication skills.
- Organizational, prioritization, and time management skills.
- Self-motivation and attention to detail.
Nice To Haves
- Experience with gene and cell therapies or the pharmaceutical industry.
- Statistical knowledge in biologics.
- Ability to adjust workload as priorities change.
- Experience with risk management processes.
- Experience with U.S. and international health authority inspections.
Responsibilities
- Execute global reporting control and invalid trending programs.
- Extract data from the LIMS system to support reporting requirements.
- Lead and coordinate continuous improvement activities in partnership with sites.
- Author the Annual Product Review Laboratory Section.
- Author technical quarterly invalid and biannual control trending reports.
- Work with laboratory operations to support new methods, technology, KLIMS implementation, ongoing support for new module implementations, and installation of new capabilities.
- Meet procedure-defined reporting deadlines using effective organization, prioritization, and time management.
- Communicate effectively in writing and verbally with cross-functional audiences.
- Improve processes to reduce complexity and optimize operational effectiveness.
- Support other team members as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
