BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QA Specialist to work for a leading San Diego biotechnology company.
Manage Non-Conformance Report Forms.
Ensure completeness of the non-conformance file and conduct monthly file reviews
Assist internal customers with preparation of non-conformance forms
Utilize JDE to perform transactions and verify product information.
Conduct investigations regarding non-conformance trends.
Provide support for internal and external audits
Perform other duties & projects as assigned
Carries out duties in compliance with established business policies.
Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâ€™s policies and practices.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
BS/BA degree or equivalent in related field.
1-6 years related experience.
Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
Knowledge of Quality System Regulations.
Experience with MS Office, MasterControl and JDE.
Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
Must be detail-orientated, self-motivated and available for flexible scheduling.
Strong communication, problem solving and motivational skills.
Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.
Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment.