About Nexinfo
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions.
We aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Our ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.
Job Title: Sr. Quality Control (QC) Specialist
Location: Thousand Oaks CA
Type: Contract
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.
