Scott Harrison Email & Phone Number

Quality Assurance lead for all outsourced over the counter (OTC) and medical device manufactured products including: performing the release function for all products released to the US and Canadian market, maintaining batch records and retain samples, performing complaint investigations, authoring final product specifications, authoring and maintaining.

Abbott Park, IL

• Established and maintained supplier relationships with chemical/reagent, commodity (injection molded components), and service providers utilized by the site/division. Communicated nonconformance and monitored CAPA.
• Quality representative for SCN evaluation process improvements. Team implemented Global Approved Supplier List tool and created a global evaluation team across 6 sites to perform SCN evaluations. Decreased evaluation.
• Remediated over 70 Service Provider Supplier Management Files to bring in to alignment with new procedural requirements within defined timeframe.
• Developed tracking worksheet with pivot tables to pull SCN evaluation metrics. Implementation resulted in reduction of cycle time for metric gathering from days to hours. Show less

Abbott Park, IL

• Supervised 15 Manufacturing Quality Assurance (MQA) technicians in the approval of manufacturing documentation and production lot of materials. Supervised multiple technicians in the approval of nonconformance, design.
• Acted as interim supervisor (6 months) and subsequently promoted to position… Show more Supervised 15 Manufacturing Quality Assurance (MQA) technicians in the approval of manufacturing documentation and production lot.
• Acted as interim supervisor (6 months) and subsequently promoted to position fulltime. Demonstrated ability to manage MQA technicians who were formally peers and departmental responsibilities were met.
• Improved the relationship with manufacturing concerning nonconformances and deviations. Helped to resolve issues as identified in the manufacturing environment to determine if productions should continue or cease..
• Implemented improved metrics board to communicate status of current activities within the department. The board increased visibility to current departmental status and improved prioritization of activities within the.

Abbott Park, IL

• Approved site nonconformance, CAPA, design control and standard operating procedural change control packages. Acted as Supervisory designate when supervisor was out of the office.
• Quality team member for the implementation and improvements to the sites Manufacturing Execution System; including approvals of implementation/deployment plans and software lifecycle documentation. The changes improved.
• Quality team member for the implementation and improvements to the sites Manufacturing Execution System; including approvals of implementation/deployment plans and software lifecycle documentation. The changes improved.
• Led improvement projects to update quality inspection procedures to standardize the inspection process of manufacturing documentation across all areas. This provided more consistent inspections and improved compliance.

Abbott Park, IL

• Inspected and approved manufacturing documentation and production lots of material in compliance with site operating procedures, cGMP guidelines and FDA Regulations
• Led multiple procedural update teams; including updates to inspection, approval, and documentation procedures. This provided more consistent inspections and the procedures were easier to use.

Abbott Park, IL

• Performed test method characterization and validation activities for assay test methods.
• Developed “gold standard” characterization report utilized for all test method characterizations performed during test method validation remediation activities. Resulted in consistent characterization reports across.