Aseptic Quality Control Technician - GMP Compliance Expert

Alyson L. Birt

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

Professional Summary

Detail-oriented and self-motivated Aseptic Quality Control Technician with 5+ years of success in pharmaceutical and biopharmaceutical manufacturing. Renowned for maintaining calm under pressure, improving compliance procedures, and consistently delivering inspection-ready results. Adept at managing documentation, training new team members, and supporting GMP-compliant operations in fast-paced environments. Professional Experience

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

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

• Utilize MODA for sample data entry, tracking, and analysis.

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

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

• Spearheaded a procedural audit initiative that improved compliance readiness, reducing pre-inspection errors by 30%.

• Trained and mentored 10+ new team members, improving onboarding efficiency and team productivity.

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

• Played a key role in maintaining a 100% pass rate during regulatory inspections over the last 2 years.

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

2018 – 2021

• Performed tissue processing operations in a full-gown cleanroom environment using specialized aseptic methods and instrumentation.

• Collaborated with regulatory and QA departments to maintain compliance during all stages of processing.

• Accurately documented manufacturing and shipping procedures in accordance with Federal and State regulations.

• Handled high-volume tissue processing with zero deviations across a span of 3 years.

• Developed and refined SOPs in partnership with QA, reducing processing inconsistencies by 25%.

• Maintained cleanroom integrity across multiple shifts and supported inventory optimization, saving 15% on supply waste.

• Oversaw lab sanitation, equipment maintenance, and supply inventory to support uninterrupted workflow. Education

Sinclair Community College

Associate of Science – Biology Emphasis, 2007

Shawnee High School, 2003

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

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