Operations Manager Management System
Resume:
David B. Coles
Greenwood, Indiana 46143
*********@*******.***
317-***-**** Home; 317-***-**** Cell
OBJECTIVE
Results oriented professional with 18+ years in a cGMP biopharmaceutical work environment, possessing a diverse background, strong desire, and proven track record of achieving continuous improvement in multiple disciplines within the business, aiming to leverage my skills, knowledge, and years of experience to effectively fill a leadership role within your company.
Professional Development and Training
Microsoft Word, Excel, & PowerPoint
Pilgrim Smartsolve Quality Management System (QMS)
TrackWise, QMS
ComplianceWire Electronic Learning Management System
Good Manufacturing Practices (GMP) Train the Trainer Qualified
SAP/R3
ISO 9001
Kaizen
Skills
Analytical Thinking
Team Leadership
Organization & Prioritization
Strong Written and Verbal Communication
Open-minded & Flexible
Tremendous Work Ethic
EXPERIENCE
Enzon, Sigma-Tau Pharmasource, Exelead, MilliporeSigma (Same business via several company acquisitions) Employed From: April 2006 To: Aug 2024
Manufacturing Filling/Packaging Supervisor (Enzon/Sigma-Tau) 2006-2012
Key Accomplishments:
Led capital improvement project to purchase, validate, commission, and implement new packaging line equipment, including vial labeler, vision system, and laser coding units. Facilitated design and layout of new packaging room and product vial inspection room
Major Position Responsibilities:
Scheduling, assigning, and directing the work of manufacturing filling/packaging personnel, Monitoring and optimizing production and process goals
Oversee training of new and existing employees
Assurance of compliance with current Good Manufacturing Practices (cGMPs), authoring/updating manufacturing department’s-controlled documents, including MPCRs, Operational Procedures, Work Instructions, and Forms with emphasis on Good Documentation Practices (GDPs)
Supervising the cleaning, sanitization, and maintenance of designated manufacturing spaces and equipment
Interview and selection of prospective employees
Technical Support Supervisor/QA Lead Training and Documentation (Sigma-Tau/Exelead) 2012-2021
Key Accomplishments:
One of two Training Administration Super Users responsible for transitioning site from paper-based training to Electronic Learning Management System
Implemented Employee Onboarding, Status Change, and Exiting Procedure for the site, which included the creation of seven (7) facilitated new hire employee orientation/training system sessions
Implemented site’s Train the Trainer Program
Recorded only one training and/or training system related audit observation at the site from 2012-2021.
Major Position Responsibilities:
Facilitated all employee training related functions including new hire training assignments, ongoing training assignment additions due to job or role change, as well removal of personnel/assignments from the system upon termination of employment
Provided training system support as subject Matter Expert (SME) during internal and external audits
Worked as training system Super User to troubleshoot and find resolution to system discrepancies and field site training system inquiries
Developed, enhanced, managed, and ensured compliance of the training system
Lead and coordinated training system improvement projects at the site
Manager, Materials Management (Exelead) 2021-2022
Key Accomplishments:
Drafted and implemented product specific shipping work instructions, including that for COVID-19 vaccine to improve Quality Assurance and Shipping Department personnel’s efficiency, attention to detail for each product-specific shipment, and to improve first-time right performance, while reducing human-error CAPA’s
Major Position Responsibilities:
Managed shipments of finished goods, clinical supplies, and Quality Control samples to distribution sites, clinical testing facilities, customers, patients or contract labs, and be familiar with requirements of overseas distribution
Maintained all aspects of plant warehouse, inventory management, and personnel to ensure compliance of cGMP’s and all State/Federal Agencies regulatory requirements
Maintained environment of inspection readiness for regulatory agencies and clients including:
1.Developing accurate and up-to-date Operational Procedures with all department training within compliance.
2.Minimized quality issues related to backlog.
3.Provided leadership to foster continuous improvement while actively pursuing cost saving projects that bring financial value to the site.
QA Lead, Training and Documentation (Exelead/MilliporeSigma) 2022-2024
Key Accomplishments:
Retained by MilliporeSigma as an essential employee with a retention sign-on bonus. Played critical role on project team to migrate legacy Exelead QMS and ELMS training data to MilliporeSigma’s global systems (ManGo/HR4YOU).
EDUCATION
Indiana Wesleyan University Bachelor of Science in Business Management, Cum Laude
References provided upon request
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