Sr. Quality Control (QC) Specialist - Control Trending

VARITE is looking for qualified Sr. Quality Control (QC) Specialist in El Segundo, CA 90404 (Hybrid)
 
WHAT THE CLIENT DOES?
An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.
 
WHAT WE DO?
Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.
 
Job Title: Sr. Quality Control (QC) Specialist
Location: El Segundo, CA 90404 (Hybrid - 3 days onsite - Tue/Wed/Thur)
Contract Duration: 10 months (Possible Extension)
Pay Rate Range: $50.00/hr. to $53.95/hr. on W2
 
HERE’S WHAT YOU’LL DO
Summary:

• Everyone at the company is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
• We are in search of a highly motivated individual to join us as a Sr. Quality Control (QC) Specialist, located at our El Segundo, California location.
• 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.

 
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.

• 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.

 
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.

 
BENEFITS:
We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

 
If this opportunity interests you, please respond by clicking on EasyApply.
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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.