Synopsis

Current site lead responsible for Training and Development and Quality Systems for the last 4 years with a focus on management and leadership. Development, creation, and ownership of multiple quality systems. Excellent written and oral communication skills with the ability to interface efficiently across multiple departments and sites. Adaptive and quick learner with capability to multi-task to meet deadlines while still upholding quality standards.

Achievements

SME in the following areas: Quality Assurance: Management of Change Controls and Deviations, GXP Training, People Management, Facility Systems, Project Management and Supply Chain/Logistics

Leadership in Pharmaceutical Regulations and Quality Systems which includes: Validation, Critical Utilities, Batch Release, Documentation Management, Internal/External Auditing (FDA, DEA), TSA certifications and program manager, Investigations, Annual Product Reviews, GXPs, Safety, Employee Management and Development

Expertise in Quality Procedures, Processes and Systems across multiple functional departments

System expertise: ExcelSafe, Trackwise, SAP, DMS, ComplianceWire, Plateau, Maximo, LIMS

Professional Experience

Fresenius Kabi LLC, Wilson, NC 2013 – 2017

BD Rx, Wilson, NC (acquired by Fresenius Kabi LLC 01/2016)

Quality Systems (Internal Audits, Change Controls, Complaints System Owner)

Training and Development (Site Management/System Owner)

Management of Site Training and Development, Quality Systems, and critical validation system improvements

Compliance development for Critical Utilities and Periodic Review comparison

Conduct reviews of batch release documentation to improve RFT, SOPs, documentation, laboratory data, and streamlining processes for batch release

Manage the controlled substance program (training, material, access, security)

Manage project deliverables and timelines to ensure compliance with regulations, procedures, and best practices (process flow, root cause analysis, trend analysis, process improvement)

Manage and maintain the site change control system and communication for global changes

Development/Validation of Trackwise system for Change Controls

Provide metrics for Quality Management Review information for change controls and site training

Manage and maintain product complaints including incoming complaints, investigation process, final complaint summary, metrics, and final communication

Manage and develop site training system (cGMP, tracking, development, multiple sites)

Manage internal audit program and develop audit training for the site

Perform Periodic Reviews and Annual Product Reviews for site product schedule

Grifols (Talercris), Clayton, NC

Sr. Technical Training Specialist 2007 – 2013

Manage and maintain change controls, investigations, training and TSA program for Supply Chain/Logistics, Warehouse

Manage and maintain Change Controls throughout its lifecycle: creation/revision, review and approval, effectivity, obsolescence, and assignment to appropriate employee job functions

Lead for internal and external audits (internal audit program, FDA, TSA, Vendors)

Supervise, manage and mentor other departmental team members to provide guidance and advancement

Supervise site changes (SOPs and BPRs) to be current with company processes for employees and maintain regulatory compliance

Lead the development of training plans for new products or significant process changes through SOPs to ensure compliance

Identify gaps and deliver and coordinate learning and learning solutions to address these gaps

Accountable for independent decision making and representation of the Supply Chain department in cross-functional teams

Lead transportation of finished goods for all TSA shipments and evaluate site inventory cycle count within SAP

Identify and Implement Safety/Technical training elements and Manage the tracking of employee training

Quality Stewardship Supply Chain site representative for site improvement projects

Manage the Maximo work order request for Supply Chain department

Grifols (Talercris), Clayton, NC

Quality Associate II 2005 – 2007

Project Manager for multiple Quality Projects, SME for batch review and release, cGMPs and Safety Training

Review and release of batch disposition including laboratory analysis, finished product, and distribution

Develop, implement and evaluate training programs across the site

Implement Change Controls for Supply Chain department (revision, supervise, follow-up)

Project Lead for Supply Chain area improvements and upgrades

Provide quality support in complex projects utilizing internal and external resources

Work with internal and external contacts with the review and release of product

Perform review/audits documentation, center status, and temperature status of all documents associated with vendor batches (follow-ups according to cGMP and SOP requirements)

Review drug product batch records, associated documentation and test and inspection data for cGMP and specification compliance to approve/reject product

Identify areas of non-compliance or opportunities for continuous improvement and worked with departments to achieve resolution

Grifols (Talercris), Clayton, NC

Validation Engineer 2004 – 2005

Schedule and execute validation studies, protocols, project, production and revalidation requirements

Evaluate and analyze data collected during projects, verify adequacy, compliance with regulations, author final reports, and assemble validation packets

Prepare, program, maintain, and use data acquisition systems for validation of equipment and processes

Carolina Turkey, Mt. Olive 2004 – 2004

Quality Supervisor

Supervisor of a team of multiple direct reports to organize their daily functions

Supervise QA Technicians in daily responsibilities (GMP, HACCP, AND SSOP activities)

Provide guidance to Operations management to assure compliance in maintenance of company policies and programs

Provide metrics to production and management to identify activity trends

Conduct training and cross training of QA technicians

Provide QA involvement in the Plant Improvement, Trim Performance, Foreign material reduction, and Production KPI, sanitation and safety

Purdue Pharmaceuticals, Wilson NC 2003-2004

Training Specialist, Quality Assurance

Develop, Manage and Implement Training Department for documentation, tracking, filing system, and certifications

Administer and maintain the SAP Qualification Management System

Assess training alignment between sites (member of site training team) and ensure compliance to all regulatory requirements

Purdue Pharmaceuticals, Wilson NC

Quality Assurance Specialist 2001-2003

Approve drug product batch records, associated documentation, inspection data for cGMP and specification compliance to approve/reject finished product

Prepare, review and approve deviations, investigations, customer complaints, and Annual Product Review

Evaluate, revise and implement AQL/In-process practices for the packaging area

Supervise audit team to strengthen the current program and conduct internal audits of the facility

Sample, perform inspections and review QC laboratory inspection data for raw materials and packaging materials

Author, perform review for compliance to cGMPs, and approve documentation

Perform validation of Quality tracking systems to insure compliance

GlaxoSmithKline, Zebulon NC 1999-2001

Quality Associate

Supervise packaging lines for batch disposition and product release

Education

Bachelor of Science in Biological Sciences

North Carolina State University, Raleigh, NC, 1999

References

Provided upon request

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