Jillian Reid Email and Phone Number

•Write and execute validations and/or protocols for manufacturing processes and laboratory instruments and methods.•Utilize TrackWise 10 to initiate and manage change controls associated with validations.•Lead and manage multiple projects from initiation to completion.•Serve as a mentor to other Quality Laboratory positions. Provide training and work direction for Laboratory technicians as required. Manage workflow and laboratory release functions in specified laboratory… Show more •Write and execute validations and/or protocols for manufacturing processes and laboratory instruments and methods.•Utilize TrackWise 10 to initiate and manage change controls associated with validations.•Lead and manage multiple projects from initiation to completion.•Serve as a mentor to other Quality Laboratory positions. Provide training and work direction for Laboratory technicians as required. Manage workflow and laboratory release functions in specified laboratory areas.•Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.•Use sophisticated laboratory instrumentation and computer systems to collect, analyze and record data.•Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.•Work on special project/protocol testing that involves new methods and instrumentation. Complete all testing, including special project/protocol testing in a timely and appropriate manner.•Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. Investigate deviations and write exception documents.•Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.•Perform laboratory and manufacturing audits as required. Audit and update, as required, SOPs.•Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems. Show less

•Executed thorough investigations and completed nonconformance events in an effective and timely manner to meet product fulfillment dates (TrackWise 8).•Collaborated with other Quality, Manufacturing, and support departments to perform RCA and identify appropriate CAPAs.•Led and supported problem solving sessions through application of various problem-solving tools and methods.•Conducted investigative audits of manufacturing areas.•Performed investigative sampling of… Show more •Executed thorough investigations and completed nonconformance events in an effective and timely manner to meet product fulfillment dates (TrackWise 8).•Collaborated with other Quality, Manufacturing, and support departments to perform RCA and identify appropriate CAPAs.•Led and supported problem solving sessions through application of various problem-solving tools and methods.•Conducted investigative audits of manufacturing areas.•Performed investigative sampling of manufacturing areas.•Prepared and presented trend analyses to management during routine operating mechanisms.•Supported Contamination Control Program initiatives to mitigate and prevent risk to product.•Supported internal and external laboratory audit readiness efforts.•Mentored other Quality Laboratory positions and provided training and work direction for Quality Control positions.•Prepared and revised documentation that supports proper functioning of lab operations.•Queried data, performed analyses, and prepared monthly and quarterly reports. Show less

•Investigated deviations, non-conformances, and wrote exception documents (TrackWise 8).•Queried data, performed analyses, and prepared monthly and quarterly environmental monitoring reports.•Managed projects, continuous improvement plans, and supported implementation of changes.•Participated in functions involving teams, which impacted production, increased efficiency, solved problems, generated cost savings, and improved quality.•Wrote/executed/supported validations for… Show more •Investigated deviations, non-conformances, and wrote exception documents (TrackWise 8).•Queried data, performed analyses, and prepared monthly and quarterly environmental monitoring reports.•Managed projects, continuous improvement plans, and supported implementation of changes.•Participated in functions involving teams, which impacted production, increased efficiency, solved problems, generated cost savings, and improved quality.•Wrote/executed/supported validations for laboratory testing processes and methods.•Performed review of test data and release functions in LIMS.•Served as primary LIMS administrator.•Maintained data integrity and ensured compliance with company Standard Operating Procedures/Specifications, United States Pharmacopoeia, Code of Federal Regulations, Quality System Regulations, and Current Good Manufacturing Practices.•Performed laboratory and manufacturing audits. Audited and updated plant SOPs.•Served as mentor to other Quality Laboratory positions. Provided training and work direction for QLA II positions.•Lead/Supervised eight employees within the Environmental Monitoring Microbiology Laboratory. Show less

•Performed routine and non-routine analysis of environmental monitoring program, raw materials, in-process and finished products during release or stability testing. •Assisted in management of test samples, regents, and materials used in the laboratory per approved procedures. •Trained Quality Control personnel on testing/policies.•Performed routine laboratory equipment maintenance.•Revised and updated SOPs.•Performed testing in support of method validation studies.

•Executed routine testing in compliance with United States Pharmacopoeia (USP), Code of Federal Regulations (CFR), and Current Good Manufacturing Practices while strictly adhering to standard operating procedures (SOPs) and standard work instructions (SWIs).•Performed time critical sterility (membrane filtration and direct inoculation) and bioburden testing.•Other testing: Container closure verification, major A and B testing, and yellow fever final identification•Conducted dynamic… Show more •Executed routine testing in compliance with United States Pharmacopoeia (USP), Code of Federal Regulations (CFR), and Current Good Manufacturing Practices while strictly adhering to standard operating procedures (SOPs) and standard work instructions (SWIs).•Performed time critical sterility (membrane filtration and direct inoculation) and bioburden testing.•Other testing: Container closure verification, major A and B testing, and yellow fever final identification•Conducted dynamic environmental monitoring (volumetric air sampling, surface sampling, and air monitoring).•Performed final reads of sterility test vessels and simulated fills.•Supported read of Aseptic Processing Area Simulated fills.•Cleaned and maintained the La Calhene sterility isolators and chambers.•Sterilized equipment, media, and samples using peracetic acid•Provided training on procedure, processes, and equipment•Performed audits of related areas•Recorded inventory of materials and supplies•Received samples and reported results using a validated data management system•Deviation investigation procedure and write-up Show less

•Performed total coliform, fecal coliform, and ice cream testing in compliance with the Department of Environmental Protection and Department of Agriculture while following SOPs. •Test methods: Membrane filtration and SMA pour plate•Other sampling: Swine, beef, and turkey carcasses with testing for Listeria and Salmonella species•Performed transfers of suspect colonies in order to confirm E. coli positive samples•Media preparation of testing broths and agars•Use of aseptic… Show more •Performed total coliform, fecal coliform, and ice cream testing in compliance with the Department of Environmental Protection and Department of Agriculture while following SOPs. •Test methods: Membrane filtration and SMA pour plate•Other sampling: Swine, beef, and turkey carcasses with testing for Listeria and Salmonella species•Performed transfers of suspect colonies in order to confirm E. coli positive samples•Media preparation of testing broths and agars•Use of aseptic technique•Autoclave operation and maintenance Show less