John Bacon
Troy,NY
Summary
Results-driven Quality Assurance professional with extensive experience in GMP and ISO environments, adept at coordinating diverse teams and managing complex projects. Proven expertise in strategic planning and operational improvement, leading to enhanced efficiency and quality compliance. Successfully implemented innovative solutions that fostered positive organizational changes and collaborative work environments.
Overview
31
31
years of professional experience
Work History
Associate Manager QA Investigations
Regeneron
Rensselaer, NY
10.2021 - Current
- Delegated work to staff, setting priorities and goals for investigations
- Reviewed completed work to verify consistency, quality, and conformance.
- Evaluated performance of team members and provided consistent coaching to improve skills.
- Identified opportunities for process improvements and increased efficiency
Quality Assurance Specialist
Spencer ARL
Plattsburgh, NY
11.2010 - Current
- Performed audits on over 100 production assemblies in an ISO-certified setting.
- Serves as a liaison between our company and our customers' engineering department.
- Identify areas of deficiency, and work to eliminate them.
- Creates and maintains references and resources used by assemblers to perform tasks.
Principal Quality Compliance Specialist
Regeneron
Rensselaer, NY
01.2021 - 10.2021
- Assessed and authorized the completion of investigation documents.
- Functioned as site expert in CAPA program management.
- Provided support in regulatory audits and inspections.
- Conducted quarterly audits of facilities work orders.
Senior Quality Compliance Specialist
Regeneron
Rensselaer, NY
01.2016 - 12.2020
- Maintained global compliance for clinical and commercial product lot releases.
- Facilitated collaboration between QA and other departments to achieve compliance targets.
- Served as site SME for CAPA program.
- Served as quality SME for the site pest program.
QA Specialist
Regeneron
Rensselaer, NY
01.2012 - 12.2014
- Edited and approved deviation notifications, investigations, corrective actions, change controls, SOPs, new and revised master manufacturing records.
- Coordinated with cross-functional teams to address quality issues and implement corrective actions.
- Provided technical guidance and mentorship to junior members of the QA team when needed.
- Identified quality problems and recommended solutions.
Quality Assurance
Medisca Inc
Plattsburgh, NY
10.2006 - 11.2010
- Investigate and write reports for quality and shipping complaints
- Create solutions and train employees on corrective actions
- Successfully submitted and recorded over 100 NDC with FDA.
- Audits of production ensuring SOP’s and CGMP were followed
Process Operator
Wyeth Pharmaceutical
Rouses Point, NY
10.1997 - 09.2006
- Executed raw material compounding and processing to achieve bulk or finished stages using labor aided by computer software.
- Ensured training compliance with FDA and company regulations for employees and supervisors.
- Part of a technical services team (2003-2005) that reformulated the manufacturing process of a drug currently on the marked that achieved FDA approval
- Collected and analyzed samples at various stages of the process.
Corporal E-4
United States Marine Corps
Silverdale, WA
07.1993 - 07.1997
- Provided security for Trident Missiles
- Supervised 15 Marines
Education
Clinton Community College -
Clinton Community College
Plattsburgh, NY11.2024
Diploma -
Ausable Valley
Clintonville, NY01.1993
Skills
- Collaboration skills
- Problem-solving skills
- Verbal and written communication
- Quality management systems
- Personnel management
- Team collaboration
- Correction action planning
- Critical thinking
- Regulatory compliance
- Staff training and development
Timeline
Associate Manager QA Investigations
Regeneron
10.2021 - Current
Principal Quality Compliance Specialist
Regeneron
01.2021 - 10.2021
Senior Quality Compliance Specialist
Regeneron
01.2016 - 12.2020
QA Specialist
Regeneron
01.2012 - 12.2014
Quality Assurance Specialist
Spencer ARL
11.2010 - Current
Quality Assurance
Medisca Inc
10.2006 - 11.2010
Process Operator
Wyeth Pharmaceutical
10.1997 - 09.2006
Corporal E-4
United States Marine Corps
07.1993 - 07.1997
Clinton Community College -
Clinton Community College
Diploma -
Ausable Valley