Quality Manager/Operations Manager

Aaron Franklin Lowe

**** *. ***** **** ***. Broken Arrow, OK 74014

918-***-**** ********@*****.***

Summary

Enthusiastic and energetic Quality Manager with experience in the pharmaceutical and medical device industry looking to join a growing and stable company. Possess strong organizational skills, as well as, enhanced problem solving and time management skills. Committed to providing a quality standard that is unmatched. Autonomous, enjoys solving problems, and thrives in fast paced work environments.

Skills and Highlights

• Audit Experience

• Superior Communication Skills

• Quality/Compliance

• Professional Integrity

• Leadership Skills

• 5s/Lean Experience

• High Business Acumen

• Speed of Execution

Experience

Access Optics, LLC, Broken Arrow, OK March 2016 - August 2016

Quality Assurance Manager

• Develop, Implement, and Maintain the Quality Management System.

• Develop, Implement, and Maintain the Continuous Improvement/Lean initiative.

• Oversee all Inspection and Quality related functions during manufacturing and assembly.

• Interface with regulatory agencies to maintain the most current regulatory requirements (FDA Registered, ISO 9001:2008 compliant, and ISO 13485:2003 compliant).

• Perform internal audits within the company and external audits of third party vendors to ensure product conformity.

• Maintain the Install Qualification (IQ), Operational Qualification (OQ), and Performance Qualification

(PQ) for all new or revised processes, procedures, and equipment.

• Participate in approval for engineering change orders, product design and development, and drawing conversions for new and existing products.

• Conduct MRB (Material Review Board) meetings to review, rework, and/or create a Non-Conforming Products Report.

• Oversee Supply Chain Management and evaluate risk(s) associated with material procurement.

• Create and utilize PFMEA's for each product to identify the potential risk within each process.

Freedom Pharmaceuticals, Inc., Broken Arrow, OK January 2013 - March 2016

Sr. QA/QC Manager

• Oversee all aspects of the company’s Quality Assurance and Quality Management Systems.

• Interface with Global Executives to participate in multiple projects meet various deadlines.

• Establish and maintain Processes/Procedures, Batch Control/Release, Customer Complaints, Returns, RCA’s, CAPA’s, Risk Management, Training, Change Management, SOP’s and Industry Compliance.

• Ensure ongoing efficiency by implementing goals, objectives, policies and procedures for QA/QC.

• Document all Product deviations and implement CAPA plans for correction action to be taken.

• Represent the site externally with domestic and international regulatory agencies.

• Participate in industry and regulatory surveillance through on-going communication and training.

• Participate and support continuous improvement and safety initiatives to eliminate waste/scrap.

• Analyze, evaluate, and, present information relating to economic trends, design and development of new products, manufacturing activities, and production capabilities.

Education

Oklahoma State University, Stillwater, OK August 2006 - May 2011

B.S. Biochemistry

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