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.
• 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.
• 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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.