Heather Dodd Email & Phone Number

Canton, GA, US

• Ensured company-wide compliance to regulatory/standards requirements, and department and division procedures including ISO, FDA, Health Canada and Japan’s MHLW
• Responsible for CAPAs, Nonconformances, Internal Audits, Suppliers, Training and Complaints
• Hosted audits with notified bodies, FDA, and distributors. Achieved MDSAP certification
• Conducted supplier audits
• Tracked and trended quality indicators and presented the data in management review meetings and quarterly to effected staff
• Performed Annual Sterilization Review

• Managed a team of Quality Control Technicians in completion of projects including disinfectant efficacy testing, B&F testing, and Potency testing by Flow Cytometry
• Created and managed a schedule for technicians to ensure efficient completion of work.
• Responsible for hiring QC technicians through candidate selection and interview
• Lead and participated on CAPA teams to determine root cause of corrective action
• Reviewed and approved changes as part of the Change Control Review Board (CCRB)
• Developed a plan to reduce EM positives within ISO class 5, 7, and 8 cleanrooms. This included changes in facility layout, material and personnel movement, cleaning schedules, environmental monitoring, and personnel.

• Named Serology Point Person for the microbiological lab. Performed biannual audit, reviewed NA0065 worksheet D, maintained archive serum and plasma, and trained new technicians on Serology.
• Responsible for completing Environmental Action Reports for all departmental water ports as well as the cleanrooms within the Bioadhesives Department.
• Environmental Monitoring of facility cleanrooms including start up, follow up, and validation by particle counts, air sampling, and surface sampling.
• Identified organisms detected during environmental monitoring.
• Conductivity, Microbial Counts and TOC testing of water from incoming, clean steam, process water, and WFI ports including follow-ups and retests.
• Open gloved Bioburden Analysis of Incoming and Preprocess tissue through membrane filtration.

• Analyzed fungi both microscopically and macroscopically to the genus level from microbial plates, tape mounts, and air-o-cells.
• Ability to speciate both Penicillium and Aspergillus.
• Analyzed and reported data accurately.
• Bacterial and fungal plating setup from various types of environmental samples

• Performed pharmaceutical product testing and raw material testing in both QC Microbiology Department and QC Chemistry Department in accordance with in house methods and USP/NF.
• Worked in a FDA GLP, and GMP regulated environment.
• Performed Purified Water Testing.
• Identified both bacteria and fungus using various proven methods.
• Reviewed laboratory notebooks and appropriate data performed by other analysts.
• Performed safety inspection of labs and other locations throughout the facility.

Bachelor Of Science, Microbiology

Education record