Marc Carls Email & Phone Number

Kalamazoo, Michigan Area

Highly accomplished Validation Specialist with 20+ years of demonstrated expertise in ensuring GxP compliance for pharmaceutical research, manufacturing, storage, shipping, and medical device manufacturers. Extensive experience encompasses all facets of Computer System Validation (CSV), specializing in ERPs, EMS, BMS, laboratory instrumentation and auditing to ensure 21 CFR Part 11 and GxP compliance. Proven ability to lead and execute validation projects from inception to completion, meticulously develop and implement multiple validation packages simultaneously, and consistently deliver compliant solutions within FDA-regulated environments. Seeking a challenging leadership role where comprehensive validation knowledge and a commitment to quality can contribute significantly to the success of a forward-thinking organization.

Responsible for the coordination of validations and managing IT projects. Created validation documentation for projects and continually managed change controls for up to 15 projects simultaneously. Helped keep templates current and prepared materials for validation training. Helped conduct Periodic Reviews for applications. Assisted in completing 21 CFR Part 11 Gap Analysis, and vendor evaluations. Managed projects at off-site facilities including Pennsylvania and China. Obtained continuing education credits for Managing IT Projects. Helped write and review system SOPs. As a Research associate maintained and observed stock animals on an off-site livestock facility. Trained in proper data collection and procedures for meeting the requirements of pharmaceutical, medical device, animal health, and chemical companies as well as governmental agencies.

Filled in for teachers as needed. Worked mostly independently overseeing classrooms from kindergarten through 12th grade at schools all over St

Made corrections on CAD drawings and arranged and maintained the file system of drawings in the automotive manufacturing industry. Reviewed purchased components and created bid packages to be sent to competitive suppliers for cost reduction.