Gregory Gerber Email & Phone Number

Stockton, California, United States

Conduct comprehensive inspection activities in alignment with the Quality Management System (QMS), meticulously assessing all site services, equipment, and processes for adherence to established operational and industry benchmarks, ensuring full compliance with contractual and corporate obligations.- Lead the determination, coordination, analysis, monitoring, and reporting of all facets of the Corrective and Preventive Action (CAPA) program, actively driving continuous improvement initiatives.- Execute ATP testing, meticulously documenting and reporting concentration levels and trends to inform strategic decision-making.- Spearheaded the coordination, documentation, and facilitation of high-impact quality training programs for site employees, ensuring a culture of excellence and compliance.- Perform rigorous Daily Visual inspections, meticulously recording findings, and providing invaluable coaching and mentorship to frontline staff in instances of failed inspections.- Ensure unwavering ISO 9001 Compliance through meticulous Daily, Weekly, and Monthly Audits, maintaining rigorous standards of operational excellence.- Compile, author, and meticulously maintain comprehensive reports on QA/QC data, providing in-depth data analysis on a weekly and monthly basis to inform strategic decision-making.- Conduct thorough Customer Surveys in strict accordance with QMS protocols and site customer survey procedures, engaging in random interactions with hospital staff to document, investigate, and report results and emerging trends, driving actionable insights for improvement initiatives.

As Quality Assurance:Inspects production in plastic injection molding for quality and consistency thats compliant to the customers needsUphold FDA/ISO standards as well as maintaining cGMP/GLP regulationsAssist in accept/reject of received goods, production start ups, in process production, rework, repair operation, and End of run documenting.Responsible for training all new hire on standard quality procedures.Inspects first runs of of production and communicate results to set-up personnel to aid them in achieving compliance.Performed periodic in-process inspections of production. As Production Lead:Assists in the supervision of the Production Dept. employees (12 -18 floor operators) for a designated work shift, creating and assigning the daily staffing matrix as requiredTrained employees and provided Dept. Manager with feedback on their performance, skills, and attendance.Assists in reporting employees absences/issues to HRParticipated in non-conformance and corrective action activities, escalating as needed to resolve and achieve commitments.Assisted in the creation and implementation of OI's and SOP's.Help and assist on the production floor to ensure standard procedures were being met.

Lodi Ca

- Led safety initiatives through regular safety walks, audits, meetings, and training sessions, prioritizing employee well-being and compliance with safety protocols.- Served as a direct backup for the Quality Control Manager, providing invaluable support in scheduling, hiring, disciplinary processes, and incident investigations.- Demonstrated leadership in implementing continuous improvement ideas and solutions, driving innovation and operational excellence across the plant.- Ensured compliance with general cGMP/GLP standards and ISO 9001 requirements, collaborating with third-party auditors during unannounced plant audits.- Conducted comprehensive quality control testing, including impact, burst, and flattening tests, maintaining the highest standards of product quality and reliability.- Facilitated daily audits to ensure internal accuracy and effectively managed customer complaints in management meetings, driving actionable insights for improvement.- Played a key role in setting up upcoming production runs, ensuring employees have access to the necessary QC tools and resources to maintain quality standards.- Maintained meticulous calibration records and schedules for quality critical tools and gauges, ensuring accuracy and reliability in all quality control processes.- Provided invaluable support in yard audits and regularly scheduled inventory control activities, ensuring optimal efficiency and accuracy in inventory management.- Conducted data entry into computer databases, ensuring the accuracy and integrity of quality control records and reports.- Played a vital role as a trainer for SafeStart, forklift operation, QC calibration procedures, and onboarding of new employees, imparting essential knowledge and skills to support organizational objectives.