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Quality Manager

Location:
Williamston, MI, 48895
Posted:
May 27, 2020

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Resume:

Adam Witters

**** * ********, *********** addgfh@r.postjobfree.com 269-***-****

www.LinkedIn.com/in/adamwitters

Quality Manager

Credentialed business leader with expertise managing and evaluating quality control initiatives. Seamlessly executed projects by coordinating schedules, allocating resources, and apportioning budgets. Capacity to assemble, supervise, lead, and train teams. Successfully postured organizations for FDA, Health Canada, and governmental audits. Commitment to interfacing cross functionally for continuous improvements. Knowledge of 5S, GMP compliance, and Quality by Design principles. Certified ISO 9001:2015 Auditor Proven expertise in:

Continuous Improvement

Staff Leadership and Training

Document Management

Material Testing

Quality Assurance

Business Continuity

Corrective Action

Problem Solving

EDUCATION AND CERTIFICATION

Master of Business Administration (2011)

University of Phoenix

Bachelor of Science, Biology

Western Michigan University

Six Sigma Green Belt Certification, Villanova University

PROFESSIONAL EXPERIENCE

Peckham – Lansing, MI

Quality Assurance Specialist/ Document Management System Administrator, 2019 to Present

Interface with customers and suppliers to ensure alignment with quality expectations.

Compile required data and create reports with insights on product defects on a monthly and quarterly basis. Develop process maps to improve the efficiency of cross functional teams. Apply knowledge of best practices and statistical techniques to drive continuous improvements. Liaise with government QAR for all contractual requirements. Address additional challenges and create new approaches to improve quality functions. Confirm adherence with Peckham's Quality Management System. Developed and delivered training to multiple sites. Performed job remotely periodically during employment.

Key Contributions:

Built teams and prepared staff for career growth and progression.

Assisted with an ISO 9001 recertification audit.

Emergent Biosolutions – Lansing, MI

Quality Control Manager - Bioassay, 2016 to 2019

Oversaw the potency test for the release of final product and stability.

Conducted laboratory investigations, validated new potency calculations, and created solutions to address quality issues. Coordinated schedules, appropriated resources, and managed budgets. Facilitated GMP activities to maintain GMP compliance, Quality by Design, and 5S. Supervised several teams and inspired staff to achieve project goals. Provided guidance and training to leadership staff. Assisted with several CDC, EU, Canadian, and FDA audits. Oversaw the design and implementation of the Laboratory Management System.

Key Contributions:

Built teams and prepared staff for career growth and progression.

Oversaw the design and implementation of the Laboratory Management System.

Served on the Biosafety and Health and Wellness Committees.

Quality Control Supervisor - Chemistry, 2016

Developed and introduced solutions to maintain compliance and streamline processes.

Quality control representative for the value streams incoming material team accountable for thoroughly reviewing internal systems and workflows. Supervised interdisciplinary teams accountable for inspecting incoming raw materials, supplies, water chemistry testing, and raw material testing. Increased the efficiency of staff schedules and supported business critical activities to ensure continuity. Applied insights to improve change controls, work orders, and laboratory investigations.

Key Contribution:

Provided in depth cross training to increase team flexibility.

Increased throughput by reducing non lab related responsibilities.

Quality Assurance Analyst II, 2014 to 2016

Participate in quality control activities and partner with teams to complete system improvements.

Monitored warehouse activities, identified inefficiencies, and implemented new processes to sustain product quality. Analyzed and classified new materials and suppliers using FMEAs. Verified the accuracy and completeness of work orders. Assisted with work orders, change controls, deviations, and investigations. Helped to create and deliver site wide classroom training.

Key Contributions:

Worked with the Value Stream Materials team to redesign and implement a new flow.

Contributed to Supplier Quality Management System improvements.

Ran UATs and performed system-wide validation testing.

Served as a subject matter expert on various SAP related issues and questions.



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