Mark Roth Email & Phone Number

Trumbull, Ct

CooperSurgical is a manufacturer and distributer of medical devices.Job Description:Investigate and evaluate product complaints.Determine if they are FDA reportable.Determine the root causes of complaints.Reveiw electronic complaint documentation for correctness.Document findings.Generate ideas for process improvement to eliminate or minimize chronic issues with devices.Achievements:Reviewed over 2500 complaints, helping to reduce the backlog.Suggested several process improvements which save manufacturing time and improve product quality.Improved the overall quality of electronic complaint documentation through review and correction.

New Milford, Ct

MedInstill is a designer and developer of medical and food devices using proprietary aseptic technology.Achievements:Developed design control SOPs which create an organized structure for design control processes and promote GMP compliance.Developed a training SOP which defines training processes and schedules to ensure personnel are knowledgeable in GMP compliance and properly trained in their job functions.Developed a Good Documentation Practices SOP that ensures personnel know the proper way to create consistent, accurate and GMP compliant documentation.Created receiving forms designed to ensure proper receipt, documentation and inspection of incoming materials.

Danbury, Ct

Moringa Source is a small manufacturer of dietary supplements and cosmetics.Acheivements:Developed SOPs which define processes for running GMP compliant quality and manufacturing operations.Conducted GMP & SOP training which created improvement in GMP compliance and job performance.Setup Cap8 semi-automatic encapsulation machine.Developed a system for operating the Cap8 and writing an operating procedure.Setup equipment and defined procedures for capsule polishing, packaging induction sealing and coding of products.Setup tea bag machine and wrote an operating procedure.Setup cosmetics formulation operation.Created new skin cream and hand lotion formulations; several considered suitable for marketing.

Danbury, Ct

Lead Auditor: Managed and tracked audit of laboratory data for R&D Auditing group. Prioritized & coordinated audit of R&D Laboratory data. Performed internal audits, GMP audits on all types of documents, reports, laboratory data and systems as needed. Managed review and handling of documents for FDA pre-approval inspection. Managed R&D controlled substance operation. Supervised two auditors and controlled substance personnel.Achievements:Created a document auditing SOP which was later adopted as a corporate wide R&Dprocedure.Developed and implemented a data review tracking system using Microsoft Excel whichenhanced the audit process and improved turn around time.Successfully managed/coordinated the transfer of the R&D controlled substance operation to new facility while continuing operations and maintaining DEA compliance.Developed new procedures for handling controlled substance which improved DEAcompliance.Improved DEA & GMP compliance by conducting training presentations for groups andindividuals.Coordinated the development of a laboratory standards SOP.

Ms, Chemistry

Ba, Chemistry

Activities and Societies: Karate Club, Concert Band