Quality Control Research Associate - III*

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title: Quality Control Research Associate - III
Location: Santa Monica, CA
Duration: 10 Months Contract
Pay rate: $35/hr $45/hr on W2

Job description:

• This role will support the Product Quality function reporting to the Director of Analytical Method Lifecycle and Trending but work cross functionally with global and site-based QC SMEs, and other departments within Technical Operations.

Responsibilities (include, but are not limited to):

• 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.

Basic 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.

If you have any questions, feel free to call me on (415) 322-5419 or send an email on akarsh.yathiraj@leadstackinc.com
Thanks and Regards
Akarsh Yathiraj Senior Recruiter C. (415) 322-5419 D. (415) 322-5419 A. 611 Gateway Blvd, Ste 120
South San Francisco, CA 94080 W. www.leadstackinc.com