Michael Borowicz Email & Phone Number

Middleton, WI, US

Middleton WI

- Ensures that our products are being manufactured in compliance with the cGMP's by maintaining an on-site presence during the manufacturing process.- Maintains and enhances our internal quality systems. - Partners with CMO's to facilitate effective communications and maintain continued compliance with the cGMP's.- Compliance review of batch.

Monitor the manufacturing and packaging of pharmaceutical products at contract facilities, to ensure GMP compliance. Additional responsibilities included:- On-site expert for the product specific manufacturing processes. - Compliance review of batch records/discrepancy resolution.- Work with the CMO staff to resolve any compliance issues. - Recommend.

Primary responsibility was to work with outside contractors, during the construction of a new pharmaceutical development and manufacturing facility, to ensure that the materials of construction, HVAC, building services, and manufacturing equipment were cGMP compliant. Some additional responsibilities included:- Investigate new manufacturing equipment.

As a Product Development Scientist II, I was responsible for the technology transfer of manufacturing processes from Product Development into Production. Some of the responsibilities of this position included: - Coordinate and Orchestrate the manufacturing of pharmaceutical demonstration batches. - Laison between the Product Development, Engineering.

Held a number of positions during my career at Searle. I was hired in the Shipping Dept. as a Packer and worked my way up through the ranks until my last position with the company, as a Sr. Pharmaceutical Technical Assistant. In that capacity I was responsible for the day-to-day operation of a Parenteral Product Pilot facility used to scale-up lab-size.