Sr. Quality Control (QC) Specialist
About The Position
The Sr. Quality Control (QC) Specialist will support global reporting controls and invalid trending programs for a biopharmaceutical company. The role includes extracting data from the LIMs system, preparing product review and trending reports, and coordinating continuous improvement activities with sites. The specialist will work with laboratory operations to support new methods, technologies, KLIMS, module implementations, and new capabilities. The position requires meeting procedural reporting deadlines, communicating effectively with cross-functional audiences, and helping improve processes and operational effectiveness.
Requirements
- Master’s degree and 4 or more years of experience in a Quality function in the pharmaceutical or biotechnology industry; or a bachelor’s degree and 6 or more years of such experience; or a high school degree and 10 or more years of such experience.
- Experience with gene and cell therapies or the pharmaceutical industry.
- Ability to adjust workload as priorities change.
- Proficiency with statistical tools such as JMP and/or Minitab.
- Proficiency in Microsoft Office applications.
- Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11/210/211, Quality Control, GMPs, and GLP.
- Effective written and oral communication skills for addressing a cross-functional audience.
- Self-motivated, detail-oriented, and willing to support other team members.
Nice To Haves
- Statistical knowledge in biologics.
- 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 or coordinate continuous improvement activities in partnership with sites.
- Author the Laboratory Section of the Annual Product Review.
- Author technical quarterly invalid and biannual control trending reports.
- Work with laboratory operations to support new methods, technology, KLIMS implementation, module implementations, and installation of new capabilities.
- Meet reporting deadlines defined by procedure, using organizational, prioritization, and time-management skills.
- Improve processes to minimize complexity and optimize operational effectiveness.
- Support other team members as needed.
Benefits
- Health benefits
- Referral program
- Growth and advancement opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
