Quality Systems Technician

Position: Quality Systems Technician I
* Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures.
* Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
* Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
* Works on assignments that are routine in nature; determines whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA.
* Analyzes equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional action to resolve the problem needs to be taken.
* Assures laboratory equipment and instrumentation is calibrated and properly maintained
* Performs operation, including routine maintenance/cleaning for analytical instruments to ensure proper operation.
* Documents investigation steps and results.
* Communicates with company personnel to investigate complaints.
* Follows all policies, guidelines, and Standard Operating Procedures (SOPs) as required.
* May refer to senior staff for assistance with day-to-day problems that may arise.
* Escalates issues to supervisor for resolution, as deemed necessary.
* Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
* Assists with various projects as assigned by direct supervisor.
* Other duties as assigned.

EDUCATION:

* Minimum 0 – 1 years of related experience.
* Understands basic concepts and principles of dialysis.
* Mathematical aptitude required with a good background in algebraic skills and measurement skills.
* Basic computer skills with database, spreadsheet, and word-processing programs.
* Strong oral and written communication skills.
* Strong attention to detail.**#1 Top Workplace in the area.*
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