Marlis Owen

CONTACT MARLIS
DIRECTOR OF SALES

Marlis.Owen@cGMPconsulting.com

Marlis is a Project Engineer with a degree in Chemical Engineering from the University of Iowa. She currently leads projects to establish comprehensive quality systems at 3PLs entering the pharmaceutical market, implement a procedure for responding to serialization defects at a packaging facility, and validate TraceLink for tracking serialized pharmaceuticals from packaging through distribution. Her experience includes managing cross-functional teams to implement changes, writing quality system documentation (acceptance specifications, MMRs, BOPs, training materials, and correspondence with the FDA), and supporting Track and Trace, tamper evidence implementation, and operational improvement projects at pharmaceutical companies. Marlis is also adept at qualifying equipment, instruments, software, facilities, and processes. Outside the office, Marlis enjoys volunteering for Make-A-Wish, traveling, skiing, running, and yoga.

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