Donna Mccall Email and Phone Number

· Hires, supervises, trains, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.· Leads and develops staff and supervises workflow.· Supervises survey and proficiency testing, and ensures timely completion.· Conducts required competency assessments and completes documentation. Takes appropriate corrective action as necessary. Provides routine and non-routine training to staff, as required, and ensures all training and/or re-training is documented.· Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.· Supervises and performs routine testing of biological samples. Ensures completion of reagent preparation, pre-qualification and quality assurance. Ensures accurate records and documentation maintenance. Ensures donor, patient, and employee confidentiality. Accountability for timely release of test results.· Maintains acceptable attendance and punctuality per the absence policy.· Liaises with vendors and clients and provides direct customer service. Communicates with customers, vendors, and couriers to ensure quality service. Assures quality customer service to all customers.· Makes recommendations to revise policies and procedures, as appropriate.· Ensures and performs preventive maintenance, quality assurance and calibrations on equipment. Identifies and repairs more complex equipment malfunctions, performs trouble shooting and notifies appropriate personnel if additional service is needed.· Ensures and is accountable for maintaining an adequate level of supplies and reagents.· Ensures the cleanliness of equipment and work areas. Ensures and is accountable for safety guidelines adherence.· Investigates deviations in testing, quality control and preventative maintenance.

· Performs all assigned duties in compliance with internal SOPs and external regulations.· Assures quality customer service to all customers.· Workflow coordination, training, and mentoring of support staff.· Oversees and performs routine testing of biological samples. Ensures completion of reagent preparation, pre-qualification and quality assurance. Maintains accurate records and documentation. Ensures donor, patient and employee confidentiality. Reviews and ensures timely release of test results.· Conducts required competency assessments and completes documentation.· Provides routine and non-routine training for staff, as required, and ensures all training and/or re-training is documented.· Oversees the timely completion of survey and proficiency testing.· Ensures and performs preventive maintenance, quality assurance and calibrations on equipment. Identifies and repairs more complex equipment malfunctions, performs trouble shooting and notifies appropriate personnel if additional service is needed.· Investigates deviations in testing, quality control and preventative maintenance.

· Review batch records and release product batches within a specified time frame.· File, retrieve and reconcile Batch Records & Quality Records· Archive and box Quality Records off-site.· Perform activities related to nonconformance, corrective actions and effectiveness checks on internal audits.· Work with manufacturing personnel to continually improve quality methods.

· Used MasterControlTM to maintain employee training documentation and SOP compliance.· GMP/GDP trainer and reviewer.· Review, edit and format documents to ensure adherence to compliance and regulatory requirements.· Maintain QA documentation retention areas to ensure documentation is available for regulatory review.· Assist internal and regulatory inspection as a single point contact towards employee training and document support.· Review, approve, track, scan, and file all Sample Request Documentation.· Provide additional administrative support as required.· Work with departments to ensure training is completed to support SOP deployment.· Served as MasterControlTM training support and document administrator.· Participated in closure of CAPAs and process improvement projects.

· Raw, in-process and final quality control· Use of instrumental (NIR and Leco) and wet chemistry techniques to measure protein, moisture, ash and free fatty acids in products· Send daily report to management team· Data entry, review and upload into SAP system for 8 labs· Conduct calibration and bias adjustment for Leco and NIR

· Review of projects and all accompanying raw data including Quality Assurance Procedure Protocols (QuAPPs) and complied reports for client delivery· High-Res Spec data review for ultra-trace analysis of dioxins/furans, PCBs, PAHs and SVOAs per EPA Methods 23, 8290, 1613, 1668, 1699, 0023A, TO-9A, CARB 428, 429 and WHO-2 in accordance with EPA regulation limits (including quality control of data and standards) for air, water, soil and tissue samples and DNR water permitting testing· Direct company contact for client, including quotes, schedule analyses and sample pickup· Scheduling and initiation of projects to be placed in the labs for analysis and methodology determination· Revision/audit and validation of laboratory methods and Standard Operating Procedures (SOPs)· Involvement with LIMS System implementation and beta testing· Sample login and chain of custody back up and overview

· Tested various environmental samples for the presence of dioxin/furans, PCBs, PAHs and ultra semi-volatiles via wet chemistry techniques and instrumental methods· Preparation, extraction, clean-up and dilution of air, soil and tissue samples to queue for ultra-trace High-Res Mass Spec Analysis· Responsible for set up, maintenance, and calibration of laboratory equipment· Preparation of spiking solutions, surrogate solutions, reagent solutions and standards for use in both the Wet Chemistry lab and Mass Spec-GC· Performed testing on solutions and standards to ensure solution integrity

· Sterilize and clean glassware and laboratory workspace· Prep trap orders and maintain all logs· Inventory of glassware and client traps for air train testing