Quality Assurance (QA) Manager - San Marcos, CA - Part-time

Quality Assurance (QA) Manager - San Marcos, CA

Job Summary:  Provide leadership for day-to-day operations of Quality Assurance and Document Control. Ensure that all goods manufactured by the Company meet the requirements of the Quality Management System and applicable regulatory requirements.

Position Type:  Contract position to cover to employee on LOA. (3-4 months)

Duties and Responsibilities:

• Direct and oversee Quality Assurance and Document Control department staff in the performance of their respective duties, and complete related HR activities, including interview, disciplinary and performance evaluation tasks.  Identify needs for, and provide training, development and support.
• Performs and/or oversees QA review and ensures products are manufactured within the guidelines of the QMS and relevant regulatory agencies.
• Representative for Quality in planning and scheduling meetings as well as Design Control.   Work in conjunction with other internal departments and external customers as appropriate, ensuring that the executive management is informed of serious complaints.   
• Conduct initial new employee training of the QMS in accordance the established Training program.             
• Oversee use and management of the Document Control system. Ensures that effective documents are controlled and distributed properly.
• Oversee all equipment calibration and environmental monitoring programs. Ensures that calibration equipment and environmental monitoring is completed in a timely manner.
• Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions (CAPA) and in accordance with the established guidelines and database systems.
• Performs internal audits of company departments and vendors, as necessary, to ensure compliance to regulations. May perform vendor audits if necessary.
• Acts as a support for customer and regulatory audits.                                
• Analyze and present related reports, data and Key Performance Indicators for management and executive review as requested.    
• Provides training and coaching to personnel within and outside the Quality departments.

Knowledge, Skills and Abilities Required:

• Ability to show initiative and to perform in a multi-task environment. 
• Good interpersonal and verbal/written communication skills. 
• Ability to work with personnel of all levels. 
• Knowledge of QSR and ISO. 
• Technical writing capability. 
• Detail oriented.

Minimum Job Requirements:

• Undergraduate degree in a biological-based science preferred or minimum of 5 years Quality Assurance, Quality Control, or combined experience, including GMP.
• Prior experience in Diagnostics industry or related field is preferred.
• Working knowledge of Quality systems, ISO, GMP/FDA processes, requirements, etc.
• Demonstrated verbal, written and interpersonal communication skills.
• Demonstrated knowledge of personal computer skills in a business environment. Microsoft Office preferred.

For immediate consideration please apply today!

Question? Please reach out to Dustin at dusg877@kellyservices.com

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.