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Mike Niedbalski, A.A., has extensive analytical and documentation experience in
pharmaceutical companies. Mike's career began at SmithKline Beecham as a Control
Analyst, performing tests on intermediate, bulk, and finished products in
accordance with in-house standards and USP Compendia. This developed Mile's
knowledge of wet chemistry methods, titrimetric procedures, and gravimetric
methods. Other analytical work involved HPLC, GC, and Apparatus 1 dissolution
baths. A promotion to Document Coordinator gave Mike responsibility for the
control and organization of files for decommissioning projects, and the tracking
and scheduling of upcoming projects. Mike also wrote protocols for building
equipment and machinery, monitored information flow among Administration,
Logistics, Maintenance, Production, Quality Assurance, and Safety, and prepared
management briefing information.
His regulatory document management skills increased at Colorcon where, as a
Global Regulatory Affairs Assistant, he coordinated customer regulatory requests
and maintained various regulatory databases used for monitoring purposes and as
references when preparing both customer and internal regulatory documentation.
Before joining Critical Path Services, Mike worked as a QC chemist and team
leader at Siegfried (USA), training chemists in wet chemistry and GC and LC
techniques. Mike's other responsibilities included reviewing laboratory
notebooks and releasing data to production, initiating and writing Laboratory
Investigation Reports and OOS / OOT Reports, and prioritizing laboratory samples
to ensure their timely release.
Mike graduated from Gloucester County College with an A.A. in Business
Administration and is pursuing a B.S. degree in Computer Science from Ellis
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