Support and lead quality investigations involving defects, non-conformances, deviations, complaints, and adverse events, ensuring timely corrective actions, reporting, data trending, and resolution.
Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed.
Ensures labels are appropriately reviewed and approved for use and meet all internal and external requirements
Reviews all steps performed and ensures that the step in the manufacturing process has taken place as defined in the Batch Production Record.
Reports findings of in-process errors and provides follow-up to ensure adequate completion of corrective actions.
Ensures for product disposition, e.g., approvals for release, distribution or rejection.
Perform statistical analyses of processes as required to meet quality control standards.
Ensure timely throughput of product through lab work queue.
Comprehensive familiarity with the lab scope and all associated lab documentation and procedures.
Operate required analytical instrumentation (GCs, FTIRs, process analyzers, etc.).
Report problems with analytical instrumentation and assist in subsequent repair(s).
Accurately input and document analytical data into all necessary analytical and plant process logs.
Strictly adhere to all necessary calibration requirements within all lab operations.
Must be willing and able to work in a highly structured work environment with regard to safe and consistent conformance to operating procedures and work practices.
Conforms to ISO 9001:2008 directives included but not limited to policy and procedures.
Support initiatives in Continuous Quality Improvement.
Through observation of work area(s), is alert to and avoid unsafe behaviors and conditions or other hazards.
Follows all safety rules/regulations and immediately reports infractions and/or workplace injuries/accidents to proper personnel.