Dariusz Gruca

Oversee over 6000 Calibration and Maintenance Project events per calendar year.

• Manage a team of coordinators, technicians, and over 30 contractors to complete all calibration work per the scheduled maintenance outage period.
• Ensure programs meet industry standards and safety quality.
• Oversee and ensure compliance when creating, revising, and editing procedures and specifications as necessary.
• Liaised with Quality Assurance for all Change Control, Triage and Investigation events am management divisions.
• Centralized all GXP calibration and maintenance functions site-wide into one centralized program resulting in improved consistency and compliance site-wide.
• Liaised with Quality Assurance for all Change Control, Triage, and Investigation events
• Accomplished multiple tasks within established timeframes.
• Managed and motivated employees to be productive and engaged in work.
• Skills: GLP, GMP, GCP, GXP, MBR, KPI

• Schedule vendors for all calibration, PM and certification of Clean Rooms
• Project leader in implementing an update calibration software Blue Mountain RAM4 (including validation), Vaisala Veriteq
• Initiating deviations, CAPAs, change controls, and authorizing calibration and maintenance SOPs
• Increased team productivity by implementing efficient workflows and setting clear expectations for staff members.
• Developed staff skills through targeted training programs, resulting in improved performance and career growth opportunities.

• Review and approve calibration records
• Handled equipment troubleshooting, repair and calibration
• Maintained documentation as per GMP standards
• Ensured conformity with FDA regulations
• Performed preventive and corrective equipment maintenance
• Create and revise MCR and ECN
• Implement new instrument to calibration dept

• Supervise calibration laboratory, including maintenance of lab equipment with master calibration files, equipment conformity as well as on- and off-site shipping to vendors
• Assist and support with new product design
• Prepare purchase orders and expense reports
• Update existing SOPs and establish new SOPs as needed
• Train departments on new equipment use
• Identified root causes to issues and implemented appropriate solutions.

• Managed calibration laboratory, maintained lab equipment to standards and performed service parts inventory
• Handled general customer service
• Updated product calibration procedure manuals, calibrated and repaired equipment
• Increased client satisfaction by providing expert technical support for all calibration-related inquiries.
• Implemented innovative solutions to address complex calibration challenges, ensuring accurate results across diverse applications.

• Handled equipment troubleshooting, repair and calibration
• Maintained documentation per GMP standards
• Ensured conformity with FDA regulations
• Performed preventive and corrective equipment maintenance
• Streamlined workflow, prioritizing tasks based on urgency and importance.
• Improved reliability of measurement systems by identifying and addressing sources of error in calibration procedures.

• Inspected and approved components for application use such as caps, bottles, jars, tubes and labels used in finished products
• Skilled at working independently and collaboratively in a team environment.
• Managed time efficiently in order to complete all tasks within deadlines.

• Facilitated validation of installation qualification/operational qualification (IQ/OQ)
• Tested products for research and development
• Conducted internal quality audits to ensure conformity to FDA, ISO, and in-house standards and regulations
• Performed Quality Control / Quality Assurance inspections
• Trained Quality Control Technicians