James Donovan
Medical Device Quality Assurance and Manufacturing Professional, Qu
Nashua,NH
Summary
I am a detail-oriented and highly organized professional with a background in medical device manufacturing and behavioral healthcare, seeking a position in the Quality Assurance department to contribute to CAPA activities. I am a strong collaborator, have excellent problem solving skills and believe in taking initiative to rise to any occasion. My work is organized, and I am a firm believer in effective and clear communication. I am adept at performing activities such as root-cause investigations, documenting results, performing verification of implementation and effectiveness (VOI/E) activities and ensuring overall compliance within a Quality Management System environment.
Overview
5
5
years of professional experience
Work History
Elderly Caregiver
Guardian Angels Senior Services
Billerica, MA
Food & Beverage Manager
Villatoro Restaurant & Cafe
Marlborough, MA
Food and Beverage Supervisor
Ken's Steakhouse
Framingham, MA
MANUFACTURING ASSOCIATE II/ CAPA COORDINATOR
REPLIGEN CORPORATION
MARLBOROUGH, MA
03.2022 - Current
- Execute CAPA Verification of Implementation (VOI) and Verification of Effectiveness (VOE) activities, producing detailed memo reports
- Collaborate with cross-functional teams to investigate non-conforming production activities, perform root-cause analysis, and assist in opening CAPAs
- Worked closely with Quality Assurance (QA), Manufacturing and Engineering groups
- Participated in NCR (Non Conformance Reports) activities, performed investigations to document occurrence and participated in determining most probable root-cause
- Trained team members in process improvements, batch records, and new test procedures
- Streamlined trainings and performed effectiveness checks
- Document all work accurately and thoroughly according to Good Documentation Practices
- Participate in the assembly, testing, and packaging of tangential flow filtration products in a fast-paced GMP environment
- Order and procure materials required for production in SAP.
MANUFACTURING ASSOCIATE
ABBOTT MEDICAL
WESTFORD, MA
06.2021 - 03.2022
- Assembled, repaired, inspected, and tested products, ensuring adherence to written instructions and quality standards
- Troubleshot equipment as needed and collaborated with cross-functional groups to investigate non-conforming activities
- Implemented safety protocols and guidelines, maintaining a safe production environment.
BEHAVIORAL TECHNICIAN
AUTISM BEHAVIORAL CENTER
BERLIN, MA
10.2020 - 06.2021
- Monitored client progress in implementing treatment plans, collecting and inputting data into relevant software
- Implemented skill-acquisition and behavior-reduction plans
- Demonstrated strong communication skills in interacting with staff and clients
- Maintained an organized and efficient supply area, adhering to safety protocols.
PATIENT CARE TECHNICIAN
WEST SUBURBAN EYE SURGERY CENTER
WALTHAM, MA
10.2019 - 10.2020
- Maintained a safe environment for treating patients, implementing safeguards to prevent cross-infection
- Reported and troubleshot all defective or broken supplies or equipment
- Possessed strong communication skills to effectively interact with staff members, read schedules, supply sheets, product information, and technical equipment instructions
- Organized and restocked supply areas in a space-efficient and orderly manner.
Education
MASTER OF BUSINESS ADMINISTRATION (MBA) IN SUPPLY CHAIN MANAGEMENT -
FITCHBURG STATE UNIVERSITY
BACHELOR OF PSYCHOLOGY -
FRAMINGHAM STATE UNIVERSITY (FSU)
Skills
- Systems, Applications, and Products in Data Processing (SAP)
- Canea One
- Agile PLM
- TrackWise
- Standard Operating Procedures Proficient
- Manufacturing Experience
- RCA Tools- 5 Why Analysis, Fishbone Diagram, Pareto Chart
- Kaizen Events
- Basic functions of statistical analysis software Minitab
- Electronic Document Management System (EDMS)
- Office Suite, MS Excel, PowerPoint
- Inventory audit and reporting
Work Preference
Work Type
Full TimeLocation Preference
On-SiteRemoteHybridImportant To Me
Company CultureWork-life balance401k matchPaid time offHealthcare benefitsPaid sick leaveCareer advancementPersonal development programsWork from home optionQuote
It is better to fail in originality than to succeed in imitation.
Herman Melville
Timeline
MANUFACTURING ASSOCIATE II/ CAPA COORDINATOR
REPLIGEN CORPORATION
03.2022 - Current
MANUFACTURING ASSOCIATE
ABBOTT MEDICAL
06.2021 - 03.2022
BEHAVIORAL TECHNICIAN
AUTISM BEHAVIORAL CENTER
10.2020 - 06.2021
PATIENT CARE TECHNICIAN
WEST SUBURBAN EYE SURGERY CENTER
10.2019 - 10.2020
MASTER OF BUSINESS ADMINISTRATION (MBA) IN SUPPLY CHAIN MANAGEMENT -
FITCHBURG STATE UNIVERSITY
BACHELOR OF PSYCHOLOGY -
FRAMINGHAM STATE UNIVERSITY (FSU)
Elderly Caregiver
Guardian Angels Senior Services
Food & Beverage Manager
Villatoro Restaurant & Cafe
Food and Beverage Supervisor
Ken's Steakhouse