Sr. Quality Control Specialist

Job Description

Duties & Responsibilities:

• Execute global reporting control and invalid trending programs, Execute data extraction from LIMs system to support reporting requirements.
• Lead/coordinate continuous improvement activities partnering with sites.
• Author Annual Product Review Laboratory Section, Author technical quarterly invalid and biannual control trending reports.
• Interact with the laboratory operations group to support new methods, technology, and KLIMS implementation and ongoing support for new module implementations and/or installation of new capabilities.
• Meet reporting deadlines as defined per procedure demonstrating organizational, prioritization, and time management proficiencies.
• Highly effective written and oral communication skills to address a cross-functional audience, Self-motivated, detail-oriented, and willingness to support other team members, Improve processes to minimize complexities and optimize operational effectiveness.
• Proficient with statistical tools such as JMP and/or Minitab, Proficient in Microsoft Office application, Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), Quality Control, GMPs, GLP.

Required Qualifications:

• Master’s Degree and 4+ years’ experience in a Quality function in the pharmaceutical or biotechnology industry .
• OR Bachelor’s Degree and 6+ years’ experience in a Quality function in the pharmaceutical or biotechnology industry.
• OR High School Degree and 10+ years’ experience in a Quality function in the pharmaceutical or biotechnology industry.

Preferred Qualifications:

• Experience with gene and cell therapies or pharmaceutical industry, Statistical knowledge in biologics is a plus, Able to adjust workload based upon changing priorities, Experience in Risk Management processes a plus.
• Experience with US and international health authority inspections a plus.