Olivia Hardy

Energetic Manufacturing Professional with 6 years of experience in high-volume cGMP environments. Proven track record in parenteral drug product assembly, quality inspection, and team leadership. Highly skilled in maintaining rigorous safety protocols and Good Documentation Practices (GDP) to ensure product integrity and regulatory compliance.

• Regulatory Compliance: cGMP, GDP, Quality Assurance/Control (QA/QC), Safety Protocols.
• Parenteral Manufacturing: Visual Inspection, Aseptic Awareness, Component Assembly, Sterile Packaging.
• Leadership: Team Training, Batch Record Review, Conflict Resolution, Performance Optimization.
• Technical: MS Office Suite, Report Generation, Root Cause Analysis, Deviation Prevention.

Catalent Indiana, LLC, part of Novo Nordisk | Bloomington, IN
Room Lead / Operator 4 | January 2021 – Present

• Lead floor operations for parenteral drug product assembly and secondary packaging, ensuring strict adherence to Standard Operating Procedures (SOPs).
• Perform real-time Batch Record review to identify and mitigate errors, significantly reducing the frequency of deviations and quality investigations.
• Practice the visual inspection of vials, syringes, and cartridges, ensuring products meet exacting standards for particulates and container closure integrity.
• Maintain a state of constant inspection-readiness by enforcing gowning requirements and cleanroom protocols.
• Coordinate with Quality Assurance to facilitate smooth line clearances and product changeovers in a fast-paced production environment.
• Mentor and train new associates on assembly techniques and the importance of accurate documentation in a regulated life sciences setting.

Cook Medical | Ellettsville, IN
Assembler | May 2017 – December 2020

• Prepared and assembled medical device components for sterile application, following precise technical specifications.
• Verified inventory counts and material certificates to ensure traceability across the supply chain.
• Conducted rigorous inspections for sterility and packaging defects prior to warehouse transfer.
• Collaborated with the logistics team to streamline shipping and warehouse preparation.

Moduslink Global Solutions | Bloomington, IN & Smyrna, TN
Team Leader / Trainer / FQA | December 2012 – March 2017

• Delegated daily tasks to production teams, optimizing hourly output and meeting aggressive KPIs.
• Partnered with engineering and corporate leadership to identify gaps in safety protocols and implement corrective training.
• Developed and led onboarding programs for new hires, focusing on policy compliance and technical job tasks.
• Assisted in the successful relocation and startup of a new department, managing the transition of operational workflows.

Available upon request.