Aseptic QC Technician with GMP Expertise

Alyson L. Birt

n 937-***-**** ) ***.******@*****.*** n linkedin.com/in/AlysonLucileBirt

n Professional Summary

Detail-oriented Aseptic Quality Control Technician with more than 5 years of success in pharmaceutical and biopharmaceutical manufacturing. Known for maintaining calm under pressure, improving compliance procedures, and delivering inspection-ready results. Experienced in documentation management, new-hire training, and supporting GMP-compliant operations in fast-paced environments. n Professional Experience

National Resilience, Inc. – Aseptic Quality Control Technician II 2021 – Present

• Conduct routine aseptic sampling of graded manufacturing areas using full PPE protocols.

• Utilize MODA for data entry, tracking, and analysis of samples.

• Lead visual inspections and provide timely quality feedback to production teams.

• Offer SOP and compliance guidance to peers, ensuring GMP and regulatory adherence.

• Initiated a procedural audit program that improved compliance readiness and reduced pre-inspection issues.

• Trained and mentored multiple new hires, improving onboarding and productivity.

• Identified and reported environmental monitoring anomalies that led to procedural changes and enhanced sterility assurance.

• Played a key role in flawless outcomes during regulatory inspections.

• Maintain meticulous documentation in alignment with ALCOA+ principles. Axogen – Nerve Processing Technician II

2018 – 2021

• Performed tissue processing in a cleanroom environment using specialized aseptic techniques.

• Collaborated with regulatory and QA departments to ensure compliance at all stages of processing.

• Documented manufacturing and shipping procedures in line with federal and state regulations.

• Handled high-volume tissue processing with accuracy and no deviations.

• Developed and refined SOPs in partnership with QA to reduce processing inconsistencies.

• Maintained cleanroom integrity and supported inventory optimization, minimizing supply waste.

• Oversaw sanitation, equipment maintenance, and supply inventory for uninterrupted workflow. n Education

Sinclair Community College – Associate of Science, Biology Emphasis, 2007 Shawnee High School, 2003

nn Core Skills

• Aseptic Technique & Cleanroom Protocols

• Environmental Monitoring (EM)

• MODA, LIMS, SAP & GMP Documentation Systems

• SOP Interpretation & Training

• LEAN Manufacturing Principles

• Equipment Sanitation & Compliance

• Cross-Functional Collaboration

• Quality Audits & Inspection Readiness

• Time-Sensitive Task Management

• New Hire Training & Mentorship

• Recognized for calm, efficient performance under pressure

• Go-to team member for cross-functional communication

• Familiar with ISO 5–8 classifications and EM devices