Actalent Quality Assurance Manager in Davis, California
Hiring a Quality Assurance Manager with a great scientific company in Davis, CA! Great culture and environment!
Schedule: M-F day shift
Job description: The QA Manager will be responsible for maintaining an effective Quality Management System (QMS) in accordance with FDA 21CFR820 and ISO 13485 standards. Responsibilities include, but are not limited to:
• Lead internal audits and host external audits (BSI, FDA…)
• Review and approve batch records and production records for conformance to established specifications.
• Maintain document control management practices (master document list, new document implementation, document change control…)
• Maintain equipment management practices (validations, internal/external calibration…)
• Manage non-conformances, CAPAs, complaints
• Manage design control and development activities (review and approve validation and verification plans…)
• Ensure all regulatory licenses and certifications are current
• Advise (and when appropriate) coach and train personnel to ensure all activities are in compliance with our Quality Management System.
• B.A./B.S. degree.
• At least 2 years quality assurance experience in a cGMP/ISO manufacturing environment (preferably in life-science field).
• Knowledgeable on current FDA and ISO standards and regulations
• Lead auditor certified (preferred).
• Must be highly organized and detail-oriented.
• Self-assured professional who is capable of providing institutional leadership in the area of quality assurance.
• Must be approachable and willing to provide assistance/consultation in: resolving non-conformances, planning validations and verifications, product/service development.
• Have continuous improvement mindset and desire to improve current processes
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.