Heather Mason Email and Phone Number

• Provided Quality Assurance oversite to CMC team for COAs, specifications, stability reports, and method validation reports• Non-clinical report review and approval to support Phase 1 IND submission• Review and approve deviations, CAPAs, and ECs• Track and maintain files for change controls, deviations, CAPAs, and audits• System administrator for the ACE document management system, including drafting, routing, approving, and filing documents and providing training and support for the system• Manage and track employee and consultant/contractor GxP training and training files• Prepare GxP metric reports

Work with cross-functional teams to provide coaching and review investigations, including the initial assessment of criticality/reportability, root cause(s), and applicable CAPAs and effectiveness checks, ensuring that all investigations are compliant and conducted in accordance with internal controls and policy and that CAPAs are effective in removing the root cause of the deviation.Maintain 100% on-time closure of assigned investigations and change records.Quality Assurance representative for investigations and resolutions of out-of-specification (OOS), out-of-trend (OOT), and out-of-expectation (OOE) testing results as well as invalid and/or aborted assay investigations.Quality Approver for Change Controls.Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions.Monitor routine method and equipment performance for trends and adherence to existing and new quality standards.Provide Quality oversite for the development, qualification, validation, and transfer of analytical methods.Release data and COAs for all stages of lot release and review stability data and reports to support expiration dating.

Oversee independent corporate review program and approval of all OOS investigations generated at three remote compounding centers. Provide leadership and direction to investigation teams at three remote compounding centers to ensure that corporate review of investigations is conducted in accordance with internal controls and policy.Authorize the removal of QA Product Holds allowing for final product dispositioning. Assist in the remediation of the governing investigations SOPs.Assist in investigation training and monitoring for effectiveness.Provide strategic insight to development of metrics relating to relevant compliance areas.Provide monthly Compliance metrics regarding the OOS investigations by center location.Support management reports depicting trends for management review purposes.Support and participate with management during external regulatory inspections as needed. Support Company-wide strategic plans, programs and activities.Remain current in regulatory knowledge.

Lead a team of investigators responsible to evaluate, investigate, and resolve complaints, including completing the initial assessment of reportability, determining root cause of complaints, and implementing applicable corrective actions in a timely manner. Evaluate customer feedback, service records, and other sources of customer and internal information for possible complaints.Analyze complaint data, and investigate with partner cross functional teams to determine the potential impact on products and to implement improvements and reduce product defects.Track and manage the evaluation of CT tubes with Operations to drive priority and ensure timely resolution of the associated complaintsMaintain on-time complaint closure rate above 90% (100% since July 2015)Primary trainer for Train the Trainer training module for all applicable site employeesReview and update divisional and departmental proceduresPrepare, publish, and report on quality metrics trending program monthly to senior managementConduct yearly internal QMS audits as certified internal auditor and participate in audit as a local SME for complaints, feedback, and FCO’sGeneration and distribution of warranty and complaint letters for Aurora and Arlington customers

Review laboratory and general office records to maintain compliance with quality requirementsLead quarterly documentation audits for GDP compliance and publish metrics reports in a timely mannerReview and approve procedures and documentation at a department levelVerify reports, including evaluation, validation, product complaint, investigation, and USP evaluation reportsReview and provide input to divisional proceduresSME and primary trainer for GDP training modules for new hires and reviewersAssist in maintaining BPT Global R&D Stability worksheet programParticipate in the development and maintenance of an exception management systemPrepare and report on quality metrics Assist team to ensure project goals are met within time and budget constraints by taking on additional work from team members and other groups within the organization, completing priority reviews, and prioritizing work as neededPlan, execute, interpret, and evaluate validation activities for spreadsheet management and designInteract with various functions within Baxter as well as external vendors and consultants to meet team objectivesLed non-laboratory safety team and conducted quarterly department safety meetingsAssist with documentation preparation for FDA PAI Inspections

Utilized theoretical knowledge of scientific methodologies to conduct laboratory studies and generate dataConducted laboratory evaluations utilizing instrumental and wet chemical methodsPerformed method validations and process validations on a variety of chemical methods and productsLed evaluation and validation studies as study director by planning, organizing, testing, and writing reportsConducted training on a variety of chemical methods and software applicationsEnsured all documentation was in compliance with quality requirements and GDP practicesPerformed peer review and approved analysts' work for quality, completeness and GDP complianceMade knowledgeable observations and developed hypotheses for unexpected phenomena and outcomesProvided input into the design of studies, analysis of information, and the development of conclusionsMaintained laboratory areas in conformance with established standard procedures for safety and environmental issues; enforced safety regulations as a member of the Safety CommitteeParticipated in formulation studies for new products by verifying reports, reviewing, and generating data