Quality Control Project Management

Keith C. Archer

Phone: 619-***-**** E-mail: *********@*****.***

LinkedIn: www.linkedin.com/in/keithcarcher

Manager of Engineering Facilities / Plants / Manufacturing Operations – Leadership WFM

Helping Companies Translate Their Business Goals to Reality

Budgeting / 3PL / Forecasts Leadership & Team Building Project Management

Staff Training and Development Policies and Procedures Customer / Client Service

Quality Control/Compliance Research and Analyses Contract Negotiations

Inventory Management CAPA Process Improvement Risk Management

PROFESSIONAL EXPERIENCE

Holcim - Jacksonville, FL 2024 - Present

A roofing materials manufacturing company.

Maintenance and Reliability Manager

Assess and recommend capital improvements with budget recommendations, implementing them as needed.

Assess and recommend maintenance improvements with budget and Capex

Conducts annual maintenance inspections to company standards as needed

Evaluate suppliers and their services on an annual basis based on quality, customer service, and develop good Relationships

Led on-site maintenance staff in diagnosing problems and repairing appliances, HVAC, electrical, plumbing, swimming pool, carpentry, dry walling, exterior structure, and appliances.

Support property and regional managers with associate training

Promote and participate in company-sponsored training

Schedule preventive and floating maintenance, and oversee all Work Orders

Comply with and enforce all company policies and procedures and all applicable health, safety, local, and federal laws. Involved in the box walks, initial walks, and acceptance of Leasing Offices, Recreation Buildings, Amenity Buildings, model units, and every resident unit.

Assisted the development team in all maintenance-related start-up areas, including product and systems selection.

Set up, schedule, and track standard and emergency warranty requests to ensure repairs are completed per owner/contractor’s agreement.

Provide timely construction cost estimates for various projects and prepare the project budgets.

Assist in the development of operating budgets and capital.

Develop and implement specific scopes of work for building and common area.

Coordinate technical training seminars for service associates and monitor training program completion rates.

Negotiate and develop service contracts for approval and

Implement and monitor Preventative Maintenance

Monitor and allocate Turnover, CapEx Funds, and R&M

Identify resources and keep informed of local, state, and municipal building requirements and landlord-tenant affairs relating to R&M and Capital Investments.

Participate in the staffing/hiring process and identify the best candidate for the

Safety Committee Member responsible for implementing and monitoring safety practices throughout the portfolio.

Certified onboarding trainer for all new maintenance

Resilience / Ology Bio services - Alachua, FL 2021 – 2024

A technology-focused manufacturing company dedicated to broadening access to complex medicines.

Manager of Engineering/Facilities

Spearheaded the strategic planning and execution of complete lifecycles of large-scale operations and manufacturing process improvement projects. Manage the team to ensure cost-effective, safe, and timely completion of projects to meet or exceed client expectations. Assist in global Ology Bio services expansion/fit-out projects in construction, resource planning, resource assignments, budget, and schedule.

Implement time or money-saving projects in processes or utility systems. Provide high-level administrative and technical support for technicians and engineers and engineering oversight for contracted projects.

Contribute to validation protocols, reports, and processes. Comply with site regulations and best practices for manufacturing. Develop goals of direct reports, Mentor, and Coach in alignment with established department and corporate goals.

Assist in documentation of out-of-specification deviation, CAPA, Change Control, CNC, ECM, and other quality management systems.

Utilize technical knowledge in writing or approving SOPs, work instructions, test methods, requirement specs, and other documents to standardize and maintain engineering processes managed by the ENGR organization.

Lead efforts to develop a cross-functional partnership with Manufacturing, Process Development, Quality Control, Quality Assurance, and other internal customer departments.

Support and help maintain communication with key customers (DoD, commercial clients, etc.) within the range defined by business leadership. Directly participate in internal/external audits, utilizing own reports and resources.

Inspect, check, and assess the quality of the work/services the ENGR organization provides.

Organize preventive and corrective maintenance processes, including annual complete facility shutdown.

Overseeing all Project Management for the Site for future development for Building Expansion

Understand and work with CNC for the automated operation of machinery.

Illumina Inc. - San Diego, CA 2005 – 2021

A leading developer, manufacturer, and marketer of life science tools and integrated systems for large-scale analysis of genetic variation and function.

Manager: Equipment Engineering (2019 – 2021): Managed a team of engineers while interfacing and coordinating with Manufacturing, Engineering, Supply Chain, R&D, Facilities, and Quality to ensure maintenance and project activities were on time and met equipment performance goals.

Led the monitoring of team performance and oversaw equipment technical performance.

Coached and facilitated function team members in carrying out their responsibilities promptly.

Made recommendations for continuous improvement and changes to team processes for cost savings. Manage contract service providers; including scheduling, and training on required.

SOPs, coordination, and ensuring all work and documentation is performed.

following cGMP requirements.

Exercise discretion, judgment, and personal responsibility.

Demonstrate a high level of integrity.

Efficiently supported late-stage development, qualifications, and transfer of equipment used for operations.

Supervisor Equipment Engineers (2012 – 2018): Set up new manufacturing equipment for processes and incoming inspections for new tools and consumables. Led and hosted Operational Strategy and Readiness Reviews and coordinated with the necessary teams to implement equipment resolutions. Generated complete system functional specifications based on Process and Operational requirements. Created PM schedules for all machines in the lab. Consistently worked on cross-functional teams with Quality, validation, process engineering, and manufacturing. Managed multiple engineering projects. Built integrated roadmaps across priorities. Worked with vendors to implement improvements and increase uptime.

Assisted in the initial startup of a new production lab in Singapore. Responsible for >$1B in revenue in 10+ years.

Worked with the development team on an internally designed optical bead chip scanner for tech transfer into MFG.

Review projects, develop RFPs, conduct bidding, review quotes, and oversee installations.

Establish work plans and staffing for each phase of the project and

Review status on an ongoing basis.

Equipment Engineer 2 (2005 – 2012): Designed, developed, implemented, and analyzed Bead Array microarray products and systems. Performed equipment engineering design evaluations and recommended alterations.

Completed documentation of all equipment-related activities to ensure compliance with CLIA/CAP and ISO 13485 requirements.

PRIOR EMPLOYMENT DETAILS

ST Microelectronics Inc. - San Diego, CA Manager: Engineering 2001 – 2005

Served as Manager of Engineers and Technicians in a Semiconductor Facility. Provided leadership for engineering and operations, developing work processes, management systems, and people to deliver on engineering projects.

Worked on designing programs for Novellus Tools and Tel Methods/Tools using goals. Decreased Equipment Downtown (DOE) in a Quarter by 43%. Efficiently oversaw Improve Teams SPC, TQM, and 8D Program Management.

Anheuser Busch Metal Container Corp. - Riverside, CA Quality Engineer Manager 1991 – 2001

Designed tools for reducing the cost of parts by 50% with the vendor. Worked closely with Machinists and Technicians for a high-speed production line company. Maintained detailed "Downtime" reports and employee person-hour scheduling.

Coordinated special projects to reduce cost and person hours. Designed tools for robots and production equipment.

Took full responsibility for the Quality and satisfaction of domestic and foreign clients while increasing sales by 30%.

Involved in designing automatic systems to increase production by 50% and cut person hours by 40%.

Spearheaded initiative to grow solutions, increasing account penetration by 20% and exceeding revenue plans.

PROFESSIONAL DEVELOPMENT & CREDENTIALS

Bachelor of Science in Mechanical Engineering University of Florida – Gainesville, FL

Technically proficiencies: Microsoft Office suite (Word, PowerPoint, Excel), Outlook

Professional engineering experience: in ISO 13485, MDSAP, CFR 820, and IVD manufacturing. Project Management

Engineering analysis: lean manufacturing, and calibration Electrical theory, metrology, and electro-mechanics, PLC (Siemens, Allen Bradley, Tridium, Ignite), automation, electromechanical troubleshooting

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