Kevin Kerper Systems Developer Ii Email & Phone Number

Aurora, Ohio

I am a system developer focusing in OSI PI Data Historian installation, validation and documentation. The companies I work with are in the pharmaceutical market. Along with these responsibilities I am developing the quality management system to improve consistent project flow.

Cleveland/Akron, Ohio Area

• Confirmed companies policies and manufacturing techniques were compliant with the FDA, ISO standards, and international regulatory bodies. Conducted investigations on nonconformance and recommended corrective actions.
• Corrective and Preventative Action (CAPA) Process Owner.
• Rebuilt and managed the QMS training system.
• Experienced in Change Control Process [ECO/DCO]
• Conducted Internal Auditing to ensure compliance with regulatory bodies and standards.
• Technical Construction File and Design History File designer for the EU and FDA respectively.

Beachwood, Ohio

• Ensured company policies and manufacturing techniques were in compliance with FDA 21 CFR 820, ISO 13485 and ISO 17025 regulations. Conducted investigations, internal audits and CAPA’s to maintain good manufacturing and.
• Caught firmware bugs in new product software prior to FDA 510(k) submission.
• Redesigned GDP standard operating procedure to ensure company compliance and transparency.
• Exposed noncompliance of sales department through Internal Auditing of patient files.

Solon Ohio

• Guaranteed customer, company, and FDA/ISO requirements have been met by Inspecting product and documentation prior to, during and post production filling and assembly. Inspected technicians randomly for proper PPE and.
• Modified and updated QA training process. Inspectors were looking at outdated procedures and terminology leading to confusion when the inspectors got onto the manufacturing floor. After updating, new inspectors had.
• Participated on the Environmental safety council to provide a safe working environment for employees decreasing production time lost due to injury.

Solon, Ohio

• Maintained the QC lab by ordering reagents, cleaning the lab, assisting technicians with making reagents and testing samples when the technicians had full schedules.
• Overhauled expired reagent purchasing procedure. After implementation, there was no loss of production time due to lack of reagents.
• Revised surplus procedure to decrease risk of chemical reactions and exposure. Increased efficiency of removal of expired reagents from the lab. Decreased time for technicians to find retains, discovered several.
• Conducted environmental monitoring of aseptic complexes to decrease the overtime for QC technicians to save the company money.
• Trained new associates on multiple chemical analysis techniques and lab protocols taking pressure off of trainers.