As Quality Systems Team Leader I’m responsible for supervising the Quality Team at the Durham Site and for ensuring that the laboratory achieves compliance with business and regulatory requirements in a timely manner. I’m also responsible for supervising and supporting Design Control activities ensuring product files are kept up to date and risk management activities are documented. This role supervises and supports the Durham Quality Assurance team with ensuring the maintenance and monitoring of the processes of the quality management system (QMS) that assess and analyze the business activities independently.

As Quality System Specialist II I’m responsible for compiling and executing validation activities that ensure equipment (non-computerized and computerized) and that the laboratory and achieve compliance with business and regulatory requirements in a timely manner and to ensure that the validated status is maintained throughout the Operational and product lifecycle. I also continually support the Quality Assurance team with support with maintaining and monitoring the processes of the quality management system (QMS) that assess and analyze the business activities independently. o Compile and/or review validation documentation including but limited to: * Validation Plans (User Requirement Specification and User Acceptance Testing)* Validation Protocols (Design, Installation, Operational, Performance Qualifications)* Commissioning Protocols* Validation Release Certificates* Validation Summary Reports* Periodic Review Reports.o Compile and/or review Design Control and Risk documentation:* Design Control & Risk Management Plan* Design Project Roster* Set up QWARE Risk Management Softwareo Liaise with Laboratory Support Team to ensure that laboratory equipment (non-computerized and computerized) remain in a calibrated state. This will include but not limited to: * Laboratory walk-throughs to review calibration and validation label status.* Trouble shoot equipment breakdown issues* Calibrate in the creation of Commissioning Protocols for new non-computerized equipment to ensure that adequate testing is performed.

• Assist in developing quality assurance policies and procedures.• Assist in development and implementation of laboratory changes and process improvements. • Identify and investigate inconsistencies in laboratory processes. (Write Non-Conformance Reports and Corrective Actions/Preventative Actions Reports)•Analyze QC data in order to identify trends in data and respond to the fluctuations in the laboratory. • Ensure the calibration and maintenance of laboratory equipment through monitoring.• Assist in Proficiency Testing, Validation Programs, Split Specimen Analysis.• Assist in overseeing work flow in the QA department. • Help facilitate problem solving and collaboration between departments. • Coach and help develop QA team.

• Evaluate current processes and recommend improvements with the goals of increased efficiency, improved product/service quality, and overall compliance.• Perform analysis of workflow and recommend quality improvements.• Setup and perform stability studies and review results with management.• Setup validations for GC/MS instrument. • Manage all paperwork for validations and studies preformed.• Resolve all problems related to quality assurance and operations. • Conduct internal audits in all departments for CAP and Company polices. • Participate in cross-training in other departments (i.e., Screening, GC/MS, and LC/MS-MS)• Maintain spreadsheets for tracking solutions and reagents. • Act as subject matter expert for Quality related issues. • Develop quality-related processes and tools.• Identify process improvement opportunities and help over see there implementation. Participate in Laboratory improvement projects as assigned

• Responsible for the extraction and derivatization of lab samples.• Collect all aliquoted samples, along with appropriate calibrators, controls,labeled columns, tubes and vials for each GC/MS assay.• Follow Standard Operating Procedures (SOP) for extraction and derivatization. • Extract and derivative samples, calibrators and controls.• Place extracted samples into ALS vial, and into GC/MS auto sampler.• Prepare reagents and buffers, according to SOP.• Follow safety regulations and policies• Maintain safe and clean work area.