Randall Rakestraw

Experience

• 

  E.I.L. Instruments

  Nov 1984 - Jan 1985

  Metrology Technician
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  Calibration Central Inc.

  Nov 1984 - Jan 1985

  Metrology Technician
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  Kimball Electronic Laboratory

  Feb 1987 - Jan 2005

  • Director of Sales and Special Projects

    Jan 2001 - Jan 2005

  • Senior Manager

    Jan 1997 - Jan 2001

  • Sales Engineer

    Mar 1994 - Jan 1997

  • Metrology Technician

    Feb 1987 - Mar 1994
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  Kelly Engineering Resources

  Jan 2005 - Feb 2006

  Senior Metrologist
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  Johnson & Johnson (Cordis Corporation)

  Feb 2006 - Jan 2010

  Calibration Technician III

  • Conducted calibration and repair of test and measurement equipment within the medical device/pharmaceutical manufacturing and R&D environment, adhering strictly to cGMP and FDA requirements.• Managed calibration activities primarily within production areas, handling equipment ranging from complex to simple in nature.• Oversaw calibration of test equipment from various campus areas brought to the calibration laboratory due to complexity or temperature stability requirements.• Reviewed critical documentation from external vendors for accuracy and compliance to ensure results aligned with Cordis's quality system requirements.• Determined measurement uncertainty and operating parameters for new equipment, creating necessary performance support documentation. Meno dettagli

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  Goodwin Biotechnology

  Jan 2009 - Jan 2015

  Calibration/Validation Manager

  • Scheduled and coordinated staff for equipment calibration and repair at the Fort Lauderdale facility, adhering to cGMP standards and maintaining NIST traceability.• Managed the calibration/validation/preventive maintenance system, overseeing scheduling and external service coordination.• Conducted incoming inspections of outsourced instruments and acted on non-conforming results through Out of Tolerance Reports.• Ensured production schedules and calibration due dates were met.• Developed and updated SOPs for calibration and maintenance procedures.• Utilized calibration database tools to track equipment performance trends.• Reviewed calibration data for accuracy and compliance.• Executed validation protocols including IQ/OQ/PQ.• Recommended equipment purchases to improve production efficiency or accuracy. Meno dettagli

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  ADMA Biologics, Inc.

  Jan 2015 - Jan 2019

  Metrology Supervisor

  Entrusted with transitioning a significant portion of third-party calibrations in-house at Biotest to enhance calibration quality and ensure prompt response to emergency needs. Led the overhaul of the primary SOP governing metrology operations, crafting detailed calibration SOPs and datasheets to enable in-house staff to perform previously outsourced calibrations. Directed recruitment, training, and mentoring of metrology personnel, while serving as Subject Matter Expert for instrumentation Change Controls and Deviation signoff. Managed approximately 2600 calibrations annually, orchestrating efforts among metrology staff, internal stakeholders, and external vendors to prevent production delays and overdue calibrations. Ensured compliance with GMP documentation standards and leveraged instrument trend data to optimize calibration intervals. Possess in-depth knowledge of ANSI-Z540, ISO17025, and 21 CFR Part 210/211 regulations. Meno dettagli

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  New Vision Pharmaceuticals

  Jan 2019 - Apr 2024

  Calibration Manager

  Revised Unipharma's calibration program by optimizing the master SOP and implementing GMP-compliant calibration database software. Led vendor selection and negotiation processes, minimized production downtime by coordinating on-site visits and managing off-site calibrations. Strategically procured in-house calibration standards within budget constraints. Reviewed outsourced documentation and addressed non-compliance issues, overseeing approximately 850 annual calibrations using internal and external resources. Meno dettagli

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  Aveva Drug Delivery Systems

  Apr 2024 - now

  Calibration Manager