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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Berrywood DriveGreenwood, Indiana Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLE Home; PHONE NUMBER AVAILABLE CellOBJECTIVEResults 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 TrainingMicrosoft Word, Excel, & PowerPointPilgrim Smartsolve Quality Management System (QMS)TrackWise, QMSComplianceWire Electronic Learning Management SystemGood Manufacturing Practices (GMP) Train the Trainer QualifiedSAP/R3ISO 9001KaizenSkillsAnalytical ThinkingTeam LeadershipOrganization & PrioritizationStrong Written and Verbal CommunicationOpen-minded & FlexibleTremendous Work EthicEXPERIENCEEnzon, Sigma-Tau Pharmasource, Exelead, MilliporeSigma (Same business via several company acquisitions) Employed From: April 2006 To: Aug 2024Manufacturing Filling/Packaging Supervisor (Enzon/Sigma-Tau) 2006-2012Key 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 roomMajor Position Responsibilities:Scheduling, assigning, and directing the work of manufacturing filling/packaging personnel, Monitoring and optimizing production and process goalsOversee training of new and existing employeesAssurance of compliance with current Good Manufacturing Practices (cGMPs), authoring/updating manufacturing departments-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 equipmentInterview and selection of prospective employeesTechnical Support Supervisor/QA Lead Training and Documentation (Sigma-Tau/Exelead) 2012-2021Key Accomplishments:One of two Training Administration Super Users responsible for transitioning site from paper-based training to Electronic Learning Management SystemImplemented Employee Onboarding, Status Change, and Exiting Procedure for the site, which included the creation of seven (7) facilitated new hire employee orientation/training system sessionsImplemented sites Train the Trainer ProgramRecorded 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 employmentProvided training system support as subject Matter Expert (SME) during internal and external auditsWorked as training system Super User to troubleshoot and find resolution to system discrepancies and field site training system inquiriesDeveloped, enhanced, managed, and ensured compliance of the training systemLead and coordinated training system improvement projects at the siteManager, Materials Management (Exelead) 2021-2022Key Accomplishments:Drafted and implemented product specific shipping work instructions, including that for COVID-19 vaccine to improve Quality Assurance and Shipping Department personnels efficiency, attention to detail for each product-specific shipment, and to improve first-time right performance, while reducing human-error CAPAsMajor 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 distributionMaintained all aspects of plant warehouse, inventory management, and personnel to ensure compliance of cGMPs and all State/Federal Agencies regulatory requirementsMaintained 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) 2022-2024Key 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 MilliporeSigmas global systems (ManGo/HR4YOU).EDUCATIONIndiana Wesleyan University Bachelor of Science in Business Management, Cum LaudeReferences provided upon request |
