Quality Control Research Associate - III*
Job Description
Job Description 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