GRAM Names Colleen Herczak as Director of Quality Assurance and Regulatory Affairs
July 13, 2016 – Grand River Aseptic Manufacturing names Colleen Herczak as Director of Quality Assurance and Regulatory Affairs.
Grand River Aseptic Manufacturing (“GRAM”) announced today the addition of Colleen Herczak to the Company’s executive team. Herczak brings 15 years of experience in Quality Assurance and Quality Control in the life sciences industry. Herczak commented, “I am very excited to join the GRAM team! The business and quality systems at GRAM are customer-focused and strong and I’m thrilled to be a part of a company with this type of culture.”
Prior to joining GRAM, Colleen started her career in the analytical lab at Perrigo, primarily supporting product release. Following Perrigo, she joined Emergent BioSolutions where she held various positions of increasing responsibility within the Quality department and most recently held director-level positions leading teams within the Information Technology and Quality departments.
Her track record of implementing compliant, enterprise-wide business systems, lean manufacturing systems, and quality management systems will complement GRAM’s core practices and support continued growth and improvement. Colleen earned a B.S. in Biomedical Science and Chemistry from Grand Valley State University and a Masters in Quality Management from Eastern Michigan University. Additionally, she is a Certified Manager of Quality/Operational Excellence through the American Society for Quality (ASQ).
In announcing this latest addition to the team, GRAM President and CEO, Tom Ross, noted “Colleen’s experience in the life sciences industry, her oversight of sterile manufacturing operations, and work with analytical laboratory testing, validation and lot release will be vital to continue GRAM’s position as a leader in the life sciences industry in Michigan. We are proud to have her join the team.”
Colleen also stated, “I am enthusiastic about the opportunity to work with the GRAM team to continue improving the effectiveness of our systems to support our future growth plans, while ensuring that we maintain the Company’s superior quality record.”
Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing (GRAM) is a parenteral contract manufacturing organization supporting new product development and cGMP manufacturing. With a state-of-the-art cleanroom and highly trained staff, GRAM provides clinical trial and commercial material in vials or syringes for the life sciences industry.
GRAM specializes in pre-clinical, clinical, and commercial manufacturing and offers the following services: sterile product development and manufacture, lyophilization, terminal sterilization and analytical and microbiological testing, stability sample storage, labeling and packaging storage and distribution.