Quality Systems Technician I

PURPOSE AND SCOPE:

Conducts Quality audits of products assuring company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems. Functions as an information source to employees when quality issues occur.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• 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.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while