Quality Control Research Associate - III*
Leadstack Inc
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 - IIILocation: 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 View phone number on ziprecruiter.com or send an email on View email address on ziprecruiter.com
Thanks and Regards
Akarsh Yathiraj Senior Recruiter C. View phone number on ziprecruiter.com D. View phone number on ziprecruiter.com A. 611 Gateway Blvd, Ste 120
South San Francisco, CA 94080 W.
Vacancy posted 8 days ago
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