Hi! I'm Maribel Colón
I'm the founder of MC Consulting. With over 15 years of hands-on experience in heavily regulated industries and further training and development, I've obtained the skills and experience to support emerging businesses and improving the operations to those already established.
My background includes biotechnology, combination product, medical devices, pharmaceutical, radiopharm, specialty chemicals, food, and lately cannabis.
From daily operations, to process improvement, cost savings projects, validation and qualification of equipment and processes, cleaning validation, computer software validations, technology transfer, new product setup, vendor assessments, and regulatory submissions, inspections and audit readiness to QMS implementations.
In addition to my skills, through time and projects, I've been able to meet and carefully select a highly skilled and experienced team of collaborators that, together, we can finally bring a one-stop full-service Quality and Compliance consultancy service that accommodates to your specific needs and budget.
From small business owners to global facilities organizations, we are ready to support you in achieving your biggest challenges today. Contact me today and let me know how we can help!
Maribel holds a Bachelor's degree in Chemical Engineering with a concentration in Molecular Biology and certification in Industrial Biotechnology.
- Exemplar Global Certified Lead QMS Auditor
- ASQ Certified Quality Auditor
- Lean Six Sigma Black Belt
- ASTM D37 Cannabis Committee Active Member
- Certified Executive Coach focusing on women and diversity leadership development.
- Fully bilingual (English & Spanish)
Selected Previous Projects & Experience:
Auditing Services: Pfizer, Apple, GE Healthcare
Validation (multiple systems): CSL Behring, Abbott Molecular, GE Healthcare, American Blending, and Filling
QMS, GMP, and Process Improvement: GE Healthcare, Amgen, Pepsico, Pfizer, Mallinckrodt Baker, American Blending and Filling
Keywords: compliance audits, GMP readiness, ISO readiness, cannabis compliance, cosmetics compliance, new product development, biotechnology, fermentation, downstream process, DOE, lean manufacturing, GMP training, scale-up, FDA remediation, claims compliance, label compliance, cosmetics formulation.