Quality Assurance Specialist

We are currently seeking an Quality Assurance Specialist III to fill a vacant position with one of our Client, located in Camarillo, CA. If you possess the necessary qualifications and are interested in pursuing this opportunity, we kindly request that you provide us with your most up-to-date resume. We appreciate your consideration and look forward to potentially working with you.

Job Description

Collaborate with stakeholders to the management of the Quality System. Recommend and implements changes to the existing quality system with regards to nonconforming product, correctivepreventive actions, document control, quality control inspections and product release, internal audits, validations and equipment calibration and maintenance programs. Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. Regulatory submissions and compliance with applicable national and international regulations. Conducts audits and reviewsanalyzes data and documentation. Manage internal audit program and support QMS related activities. Host customer audits. Perform supplier audits, support supplier audit program. Initiate, investigate and complete corrective actions CA. Participate in the MRB meetings. Includes ability to apply problem solving tools and methods to coordinate andor lead investigation teams. Participate in the management and execution of equipment, process and software validation. Manage the equipment calibration and maintenance program. Provide directions for all aspects of testing related to manufacturing. First article inspections. In-process release inspection. Final QC release of finished goods. Document review. Ensures that all inspections and procedures are properly completed and documented. Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process. Perform environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures. Assists department with continuous improvements initiatives or lean projects. Can serve as Quality Assurance representative on facility projects. Respond to customer complaints and collaborate with internal departments for resolution and preventative corrective actions.BENEFITS include Medical, Dental and Vision Insurance, 401K plan with company match, 3 weeks of PTO, 9 pa Skills Required

BA Degree in Business, Science or Engineering. 5+ yrs exp in quality operations within a biotech or pharmaceutical manufacturing facility. Exp w root cause analysis and investigations. Initiation closure of CAPAs.