Leah Randall Email and Phone Number

AstraZeneca – Mt Vernon, IN• Manages critical Compliance and Quality System programs to ensure GMP requirements of all local/global regulations and internal Quality and Compliance Policies• Leads the Proactive Human and Organizational Performance (HOP) initiative focusing on Human Error reduction, Deviation reduction, Proactive Deviation Prevention, Change Control Management, Quality Risk management, etc.• Accountable for key business process metrics, team performance metrics, and continuous improvement metrics.• Leads the Deviation Local Process Champions site initiatives and investigation business processes supporting manufacturing operations at the Regional level as the acting Deviation Regional Business Process Owner for North and South America • Partners with other sites, Global Entities, and Global Process Owners to create standard quality system requirements and ensure compliance with Global policies.• Supports the Logistic Center and Strategy Room during Internal, External, and Regulatory Audits. Experience with ISO, CFR, ICH Regulations SME in TrackWise, GQTS, and Veeva Quality Systems • Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators.• Develops training for the site and Leads efforts to implement Lean principles and problem solving efforts / facilitates and writes Major / Critical level investigations as required

AstraZeneca – West Chester, OH• Managed Compliance and Quality System programs to ensure GMP requirements of all local/global regulations and internal Quality and Compliance Policies• Led a team of 4+ individual contributor direct reports who are responsible for facilitating all unplanned Major and Critical Manufacturing, Environmental Monitoring, Incoming Quality, etc. deviations for the site.• Led a team of 5+ direct reports who are responsible for leading and maintaining all Documentation Processes and initiatives for the site as well as the Complaint Investigation processes• Maintained site deviation and CAPA metrics, and acted as Business Process Owner for deviations and investigations. • Authors Annual Product Review reports for Deviations.• Developed the deviation and investigation training for the site. Trained site qualified investigators on problem solving, new investigative tools to reduce repeat events, reduce deviation closure cycle times, and reduce deviation criticality. • Periodically audits deviation and investigation records for compliance and improvement opportunities

• Leads a team of 4-10 individual contributor direct reports who are responsible for supporting all planned and unplanned manufacturing deviations, review and approval of product and equipment change controls (including SOPs and master batch records).• Provides leadership for Quality Operation (QO) floor support of Drug Product Operations, change control review and approval, record approvals, and project support within the Drug Product QO Organization.• Responsible for making real time Quality decisions and supporting QO functions for: West Wing, GPA, SPA, Packaging, Inspection, and Warehouse operations• Provide guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. • Provides oversight to individuals and team on personal development, performance, and quality related issues, as well as oversight of department, ensuring proper use of assets, budget, and personnel. • Communicates effectively with key customers and partners, both within and outside of the site.• Responsible for ensuring that all quality commitments and timelines are tracked and met

• Independently provides immediate Quality Impact assessments on the process, and product disposition decisions (24/7) on Drug Product issues.• Handles complex and detailed situations assess consequences of decisions as well as potential Regulatory impact on a Global Basis, and escalates issues with potential market or stability impact.• Leads/facilitates/participates/completes cross-functional team investigations for Field Alert Reports and significant deviations. • Evaluate corrective actions and identifies and implements preventive action improvements to eliminate the potential for similar non-conformities to occur • Effectively communicate complex technical issues to all levels of Site Leadership • Utilize tools such as Method 1 and Pfizer Human Performance in the course of investigations

• Acted as a Corporate and plant resource to conduct field complaint investigations and provides quality engineering consulting to support Corporate and plant activities. • Evaluated process/procedure changes as necessary and assures changes are implemented in associated plant procedures. • Reviewed and evaluated sensitive, confidential information and develop recommendations for use by plant Quality and Corporate Quality management. • Conducted complaint investigations for defects reported against product released from the site.• Facilitated cross-functional partnerships within Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other plant personnel to complete the investigation.• Evaluated corrective actions in regards to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur.

• Performed supervisor duties when the primary supervisor was unavailable• Educated department and plant personnel on proper SOP procedure to ensure line and process efficiency• Responsible for positively identifying critical and non-critical defects to determine batch failure• Audited 30+ different line processes to ensure compliance with written company / FDA specifications and procedures• Monitored CGMP’s, safety regulations, and temperature / environmental code monitoring through Daily Auditing • Performed visual inspection audits on vials, carpujects, syringes, and ampules

Coordinates and educates 100+ employees on 2nd and 3rd shift on Food Safety and Product Quality PoliciesMonitors GMP’s, safety regulations, and compliance on all company issued paperwork through Daily Internal Auditing Performs bimonthly Facility Audits Audits, tests, and verifies all HACCP CCP’s including Cook Temperatures and Metal DetectionPerforms Process Control Checks, Direct observations, and verifications on label verification documents, piece counts, and raw mixing proceduresPerforms sampling in several micro programs including Air, Raw Meat, Environmental, and daily operationalsWorks closely with Sanitation and Operations Management to discuss and review micro resultsWorks with USDA on a daily basis with daily production inspection issuesCoordinates all production processes including SOP’s, SSOPs, and daily HACCP paperworkMaintains Internal Nonconformance Programs / DatabasesPlaces / monitors products on hold and works with different departments to evaluate final disposition of products

Responsible for labeling, entering finished pallets into inventory, and insuring proper case counts on all products produced on 2nd shiftWorks with Operations Management to adjust inventory accordinglyInsures all boxes are stacked and labeled correctly including inspecting boxes for any tears or holes Transports all correct finished pallets to the distribution departmentResponsible for making adjustments and performing regular maintenance on labeling machine