Aaron Hamilton Email & Phone Number

Virginia, United States

Key Responsibilities• Accountable for the quality aspects of GMP global computerized systems used in manufacturing facilities to ensure compliance with company policies, procedures and regulatory expectations• Provide the independent quality approval of key computer system validation/SDLC documentation such as plans, requirements, test protocols and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system… Show more Key Responsibilities• Accountable for the quality aspects of GMP global computerized systems used in manufacturing facilities to ensure compliance with company policies, procedures and regulatory expectations• Provide the independent quality approval of key computer system validation/SDLC documentation such as plans, requirements, test protocols and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system life cycle• Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective• Drive resolution of regulatory non-conformance for GMP computerized systems• Participate in global computerized System project meetings providing Quality oversight • Understand appropriate IT system risks and provide directions for appropriate and tailored testing• Review SDLC documentation and provide guidance related to compliance concerns• Ensure alignment with policies, guidelines, and procedures governing System Development Life Cycle Methodologies and current regulations• Ensure compliance to data integrity requirements in a GMP environment• Guide Quality projects and support the global Quality strategy Show less

Merck point-of-contact for the Jacobs Engineering manager to close remaining punch list items during the final phase of facility construction. Worked with local IT to install SAP printers in the facility. Ordered off-the-shelf equipment needed to support cleaning, material movement, and daily manufacturing operations in the facility. Set-up operations systems for manufacturing: gowning, incoming raw material, waste flow, batch record review, daily standard work, and organization and… Show more Merck point-of-contact for the Jacobs Engineering manager to close remaining punch list items during the final phase of facility construction. Worked with local IT to install SAP printers in the facility. Ordered off-the-shelf equipment needed to support cleaning, material movement, and daily manufacturing operations in the facility. Set-up operations systems for manufacturing: gowning, incoming raw material, waste flow, batch record review, daily standard work, and organization and execution of daily tier meetings. Performed investigations and developed of CA/PA’s for safety incidents. Worked as shift supervisor during production start-up for engineering & stability batches. Show less

Singapore

Manager of 17 manufacturing technicians working rotating shifts producing solid dose products for export. Responsible for deviation investigations, CAPAs, SOP updates, batch sheet error corrections, creation of weekly production schedule, shift hand-overs, production activity control and prioritization, training of production staff, tier meetings, reporting and resolution of unsafe conditions and near misses, real-time problem solving, pitch charts, monthly pay administration, coaching and… Show more Manager of 17 manufacturing technicians working rotating shifts producing solid dose products for export. Responsible for deviation investigations, CAPAs, SOP updates, batch sheet error corrections, creation of weekly production schedule, shift hand-overs, production activity control and prioritization, training of production staff, tier meetings, reporting and resolution of unsafe conditions and near misses, real-time problem solving, pitch charts, monthly pay administration, coaching and consequence management, and cross-functional collaboration with stakeholders from technical operations, quality assurance, supply chain, warehouse, safety, and other IPT’s. Show less

Pandaan, Jawa Timur, Indonesia

Independently contracted, reporting to the Director of Operations. Managed cross-functional CAPEX project teams to upgrade legacy fire protection, video surveillance, and access control and alarm monitoring systems from project initiation to system release and acceptance. Taught recent graduate engineers best practices and a standard project management framework by example and daily interaction. Promoted a culture prioritizing safety, quality, and customer service.

Pandaan, Jawa Timur, Indonesia

Coaching production staff in a new facility during the start-up and product transfer phase. Focused on leadership and business culture assimilation during the completion of engineering work to meet regulatory requirements and first shipment deadlines for the new source of supply. Implemented visual production controls to improve flow from receiving to production lines through to finished goods shipment. Identified high value target areas for improvement such as machine changeovers, right the… Show more Coaching production staff in a new facility during the start-up and product transfer phase. Focused on leadership and business culture assimilation during the completion of engineering work to meet regulatory requirements and first shipment deadlines for the new source of supply. Implemented visual production controls to improve flow from receiving to production lines through to finished goods shipment. Identified high value target areas for improvement such as machine changeovers, right the first time documentation, safety, quality problem identification and decision making, root cause analysis, kiazens, standard work, effective on the job training, 5S, and constant audit readiness. Show less

Greater Salt Lake City Area

Directly supervising a team of 12 pharmaceutical Production Technicians in performance of work assignments primarily associated with dispensing, granulating, drying, blending, and compressing, to meet production schedules for schedule II controlled pharmaceuticals (opiates). Focused on safety and quality while evaluating WIP and making real-time decisions concerning actions to be taken in response to unexpected production events. Directed the training of new employees in a GMP environment… Show more Directly supervising a team of 12 pharmaceutical Production Technicians in performance of work assignments primarily associated with dispensing, granulating, drying, blending, and compressing, to meet production schedules for schedule II controlled pharmaceuticals (opiates). Focused on safety and quality while evaluating WIP and making real-time decisions concerning actions to be taken in response to unexpected production events. Directed the training of new employees in a GMP environment using performance based training methods, ensuring compliance with the FDA, MHRA, EMEA GMP, OSHA, EPA, DEA and other agencies. Factory leader in a major factory change from SAP to Oracle ERP systems following the acquisition of Cephalon by Teva. Overseeing the flow of batch records and reviewing all records for accuracy, completeness, and legibility, in real time while in production and again when each batch is complete. Performing process investigations and writing or revising operating procedures using soft skills and abilities to gain the cooperation and support from others.Functioning as a liaison between Quality Assurance, Process Technology, Quality Control, Supply Chain, and Senior Management stakeholders to keep priorities current and customer focused. Tracking production team metrics, subordinate staff attendance, pay, vacation and personal time off and initiating disciplinary actions in response to violations or abuse of employee policies and guidelines. Show less

Sydney, Australia

Manager of new product development initiatives for the industrial fastener and building trades industries with responsibilities for forecasting, market segment estimates, range decisions, product pricing, supplier negotiations, profit margin analysis, development of marketing material, and product launch strategies. Experienced in bypassing trade companies to directly source new products from Asian factories. Daily interaction with key members of the sales force and warehouse managers in the… Show more Manager of new product development initiatives for the industrial fastener and building trades industries with responsibilities for forecasting, market segment estimates, range decisions, product pricing, supplier negotiations, profit margin analysis, development of marketing material, and product launch strategies. Experienced in bypassing trade companies to directly source new products from Asian factories. Daily interaction with key members of the sales force and warehouse managers in the Australian and New Zealand distribution network as well as 10 factories in Taiwan, China, and India. Periodic face-to-face meetings with larger supply sites in China. Show less

Planning and schedule execution using LEAN principles for 19 pharmaceutical products composing 200+ end items. Responsible for planning, scheduling, production activity control, purchasing, inventory control, market specific requirements, new product launches, and component changes. Primary liaison between production, procurement, regulatory affairs, quality, and regional planning departments with focus on moving medicine into 30+ global markets.

Supervisor for pharmaceutical tablet manufacturing and packaging facility with direct supervision and day-to-day management of 40+ operators, fitters, electricians, cleaners, and warehouse employees. Supervised a rotating shifts with responsibilities for coaching and consequence management, shift resource planning, production scheduling, investigation of out-of-specification events, standard work/SOP creation and staff training, identification and implementation of process improvements,… Show more Supervisor for pharmaceutical tablet manufacturing and packaging facility with direct supervision and day-to-day management of 40+ operators, fitters, electricians, cleaners, and warehouse employees. Supervised a rotating shifts with responsibilities for coaching and consequence management, shift resource planning, production scheduling, investigation of out-of-specification events, standard work/SOP creation and staff training, identification and implementation of process improvements, batch record review and approval, and human error reduction (project leader). Active leader in organizational change to support company wide LEAN manufacturing initiative. Show less

Sydney, Australia

Member of product technical transfer team to transfer AIDS/HIV medicine manufacturing process from Bristol Myers in Puerto Rico to Merck in Australia. Led numerous manufacturing and packaging process change requests to completion. Technical lead for X-ray installation on tablet blister line to reduce high number of missing tablet complaints.

Greater Philadelphia Area

Collaborated with MRL to install a network based archiving solution for systems not in compliance with the 21 CFR Part 11 rule. Performed interface and network testing before deployment to 20 MMD laboratories in North America, EMEA, and Asia Pacific using shared architecture. Planned and executed the remediation of 1000+ instruments as part of a team consisting of vendors, consultants, and internal stakeholders.

Greater Philadelphia Area

Worked as a developer and anaylst as a member of a project team created to implement SQL*LIMS in 7 MMD Stability Laboratories. Gathered requirements, authored SLC documents, developed custom functionality, and executed acceptance testing.

Bachelor Of Science, Mathematics And Computer Science, With Distinction

Activities and Societies: Army ROTC The Virginia Military Institute (VMI) is a state-supported military college in Lexington, Virginia.

Rotc Military Exchange Program, Computer Science

Activities and Societies: G1 Outfit, Corps of Cadets Texas A&M University (A&M or TAMU) is a coeducational public research university.