Mal Saylor
Medford,MA
Overview
5
5
years of professional experience
Work History
Quality Control Analyst II
Vericel
Burlington, MA
10.2025 - Current
- Conducted microbial enumeration, streaked plates, and performed gram staining for out-of-range results to ensure compliance with quality standards.
- Report out-of-specification or out-of-trend results in a timely manner to ensure appropriate actions are taken.
- Perform routine Environmental Monitoring and utilities testing.
- Run sterility testing daily on final products
- Executed minimum cell viability assay on final products
- Reviewed QC data and summarized findings for management to facilitate informed decision-making.
- Performance of QC general laboratory equipment calibration and maintenance, laboratory housekeeping and preparation of the laboratory for audits.
- Maintained batch records on paper and in LIMS
- Communicate inter-departmentally and with outside contacts to solve technical issues.
- Trained team members on quality control procedures and best practices.
- Performed root cause analysis on non-conforming materials to identify problems and corrective action plans.
- Participated in regular meetings with management team members discussing progress towards achieving company objectives related to product excellence.
Quality Control Environmental Monitoring Associate
Ultragenyx
Bedford, MA
07.2024 - 09.2025
- Monitored Grade A, B, C, and D environments during static and dynamic lab functions, sampling room and personnel EM, water for injection (WFI), gas, and compressed air to ensure quality standards
- Tracked and trended WFI, gas, and compressed air data in LIMS and Excel, conducting periodic reviews and analysis of EM results for trend identification
- Reviewed procedures and provided technical expertise, enhancing SOPs and Work Instructions for compliance and efficiency
- Performs microbial enumeration of incubated plates and LIMS data entry and assists in preparing samples for transport.
Quality Control Microbiologist
Organogenesis
Norwood, MA
09.2023 - 04.2024
- Performed environmental monitoring of ISO 5 ISO 7 and ISO 8 cleanrooms at different frequencies designated by procedure, including quarterly SDA monitoring
- Performed clean utility sampling and bioburden testing using aseptic technique inside a BSC
- Performed microbial enumeration on environmental monitoring and clean utility samples, maintaining high attention to detail for reliable results.
- Executed quality control plate reading procedures, ensuring accuracy in microbial analysis to uphold quality standards.
- Reported sample excursions exceeding alert and action limits promptly to facilitate immediate corrective actions.
- Supported function of GMP microbiology labs in both the Canton and Norwood facilities both independently and in team settings
- Received tissue form materials management per QMS procedure and transferred to manufacturing for GMP production
- Worked overtime to complete late sample entry and collect early product supplies
At Sea Monitor
A.I.S., Inc.
North Dartmouth, MA
10.2022 - 01.2023
- Collected and analyzed fisheries' catch and bycatch data on fishing vessels at sea, tracking and graphing results for reporting and assessment
- Applied catch estimation methods to ensure accurate accounting of all catch brought onto commercial fishing vessels
- Photographed and identified fish species, debris, and other marine life to support biodiversity monitoring efforts
Lab Assistant
Bode Technology
Lorton, VA
02.2022 - 08.2022
- Managed freezer inventory for long and short term storage using Excel to ensure optimal sample preservation
- Managed dry storage inventory using Excel to ensure organization and accessibility.
- Maintained cleanliness and functionality of lab spaces and equipment to support ongoing research activities
- Prepared frozen and centrifuged samples for return to clients
- Trained new employees
Education
Bachelors of Science - Biology
Principia College
IL05-2021
Skills
- Aseptic Technique
- Laboratory Safety Protocols
- Pipette Proficiency
- LIMS
- Documentation review
- Microsoft Office
Timeline
Quality Control Analyst II
Vericel
10.2025 - Current
Quality Control Environmental Monitoring Associate
Ultragenyx
07.2024 - 09.2025
Quality Control Microbiologist
Organogenesis
09.2023 - 04.2024
At Sea Monitor
A.I.S., Inc.
10.2022 - 01.2023
Lab Assistant
Bode Technology
02.2022 - 08.2022
Bachelors of Science - Biology
Principia College