Damian Burningham
Sandy
Summary
Dynamic professional with strong analytical, communication, and teamwork skills, demonstrating a proven ability to adapt quickly to new environments. Committed to contributing to team success while pursuing opportunities for professional development. A positive attitude and dedication to continuous learning drive a passion for achieving excellence in every endeavor. Prepared to leverage expertise and enthusiasm to make a meaningful impact within the organization.
Overview
22
22
years of professional experience
1
1
Certification
Work History
SR. QUALITY SYSTEMS ENGINEER
Teva Pharmaceuticals
10.2023 - Current
- Author APRs by reviewing product performance through analyzing yields, release specification data, deviations, change controls, complaints, validation status, stability regression, etc.
- Provide Quality department review of qualification and validation documents for various stages of equipment and product life cycles: new product feasibility/registration/validation or process improvement protocols, product continue process verification, new equipment qualification and equipment periodic reviews.
- Support site level changes through change control discussion, review and closure.
SR. QUALITY ENGINEER
Teva Pharmaceuticals
08.2022 - 10.2023
- Provide a thorough and timely review and approval of cGMP documents and processes such as those related to validation, change documentation, deviations, investigations, equipment and facilities qualifications, protocols and reports, and facility controls, instruments and procedures.
- Manage the site change control system.
- Provide first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
- Read, write, review and approve investigation reports due to deviation from manufacturing processes and/or expected results.
MS&T SPECIALIST II
Teva Pharmaceuticals
03.2019 - 08.2022
- Technology Transfer: Writing, executing and summarizing feasibility, development, submission, validation and process performance protocols.
- Annual, Continuous Process Verification (CPV) for multiple products by analyzing Critical Quality Attribute (CQA) and process capability analysis/interpretation using statistical software (JMP).
- Provide Subject Matter Expert (SME) technical assessments in support of investigations involving adverse process events, out-of-tolerance (OOT) and/or out-of-specification (OOS) testing results.
MS&T SPECIALIST I
Teva Pharmaceuticals
01.2014 - 03.2019
- Review qualification status and author summary reports for equipment within the periodic review program.
- Author annual facility system reports that review performance compared to expected standards: Air Handler Units (AHUs), environmental monitoring, purified water/clean steam systems and solvent delivery systems.
LEAD MANUFACTURING TECHNICIAN
Teva Pharmaceuticals
09.2011 - 01.2014
- Ensure strict adherence to quality/GMP standards and Health and Safety standard and escalated issues as needed.
- Set high standards for meeting schedule demands by being able to shift focuses based on supply chain priorities while being a positive/supporting leader.
SENIOR MANUFACTURING TECHNICIAN (TOP SPRAY GRANULATION AND BULK BLENDING DEPT.)
Schiff Nutrition International
01.2004 - 09.2011
- Ensure strict adherence to quality/GMP standards and Health and Safety standards and escalated issues as needed.
- Set high standards for meeting schedule demands by being able to shift focuses based on supply chain priorities while being a positive/supporting leader.
- Update Standard Operating Procedures (SOPs) as needed.
Education
B.S. - Business Management
Western Governors University
Salt Lake City, UTA.A.S. - Aviation Maintenance
Salt Lake Community College
Salt Lake City, UTSkills
- Advanced Microsoft Excel skills
- Proficient in oral dosage technologies
- TrackWise system management
- Experienced in managing electronic documents
- Skilled in data analysis using JMP software
- Clear and concise communication skills
- Experience with SAP inventory management
- Skilled in cross-functional collaboration
Certification
BCIT Technical Writing Certification
Timeline
SR. QUALITY SYSTEMS ENGINEER
Teva Pharmaceuticals
10.2023 - Current
SR. QUALITY ENGINEER
Teva Pharmaceuticals
08.2022 - 10.2023
MS&T SPECIALIST II
Teva Pharmaceuticals
03.2019 - 08.2022
MS&T SPECIALIST I
Teva Pharmaceuticals
01.2014 - 03.2019
LEAD MANUFACTURING TECHNICIAN
Teva Pharmaceuticals
09.2011 - 01.2014
SENIOR MANUFACTURING TECHNICIAN (TOP SPRAY GRANULATION AND BULK BLENDING DEPT.)
Schiff Nutrition International
01.2004 - 09.2011
A.A.S. - Aviation Maintenance
Salt Lake Community College
B.S. - Business Management
Western Governors University