Our client, a Biopharmaceutical company, is looking for a Sr. Quality Control (QC) Specialist for their Walnut Park, CA/ Santa Monica , CA/Remote location.
Responsibilities:
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.
Requirements:
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.
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.
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
Biotech and Pharmaceuticalunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Establish Prioritiesunmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
Health Planunmatched
International Healthunmatched
Laboratory Operationsunmatched
Microsoft Officeunmatched
Minitabunmatched
Operational Supportunmatched
Operations Processesunmatched
Presentation/Verbal Skillsunmatched
Procedure Developmentunmatched
Process Improvementunmatched
Product Reviewsunmatched
Quality Controlunmatched
Quality System Requirements (QSR)unmatched
Regulatory Requirementsunmatched
Risk Managementunmatched
Secondary Schoolunmatched
Time Managementunmatched
Trend Analysisunmatched
Writing Skillsunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.