Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Quality Control Research Associate - III.
Job Description:
Job Title: Quality Control Research Associate - III
Job Type: Contract
Job Location: Walnut Park, CA
Work Schedule: Onsite
Pay Rate: $53, Based on experience
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.
About Maxonic:
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Interested in Applying?
Please apply with your most current resume. Feel free to contact Moksha Kalra (/) for more details.
