Quality Customer Service
Resume:
Sonia G. Stevens-Robison
China Grove, NC 28023
Cell 704-***-****
Email: ***********@*****.***
Objective: To obtain a position where I can maximize my quality assurance, leadership, customer service, and
organizational skills that offers professional growth. Over 20 years of experience within the FDA Regulated industry
with emphasis on Quality Systems, CAPA, Customer Complaint handling, Investigations/Deviation reporting, root
cause analysis, change control and document/records management ensuring cGMP compliance. Ten years of
experience hosting FDA regulatory inspections, client and corporate audits and conducting internal and external audits.
Extensive background with manufacturing, analytical and facility qualification activities as well as validation
procedures for manufacturing processes.
Professional Experience:
Octapharma Plasma Incorporated, Charlotte, NC (February 2013 – January 2014)
Quality Assurance Supervisor
• Collaborate closely with other sites to share best practices and pro-actively drive improvements
Develop and maintain effective relationships through timely communication.
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• Provided leadership and guidance for effective and timely communication and appropriate escalation of
product quality issues to all levels of the organization.
• Quality Management controls – Deviations and non-conformances, CAPA Management with emphasis on
alignment of root cause analysis and CAPA effectiveness.
• Assist with the management of receiving and handling (documentation, investigation, resolution and closeout)
of all Product Quality Complaints and patient related events in a manner that complies with regulatory
requirements (21 CFR Parts 210, 211 and 820).
• Assist with Audit Readiness by ensuring all audit materials are up to date (e.g. FDA responses,
483 and warning letters).
• Perform trend analysis of audit observations or compliance issues and address trending issues with the
appropriate personnel for resolution.
• Confirm that the proper documentation of changes is properly documented through change control.
• Conduct audits to identify non-conformances in adherence to protocols, SOP’s and regulations.
• Supports internal and external GMP related Audits.
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic,
flexible and constructive manner.
• Reviews and provides quality impact assessments for quality systems, change control and manufacturing
deviations and investigations.
Talecris Plasma Resources, Charlotte, NC (January 2008 – February 2013)
Quality Assurance Supervisor
• Ensures the total operation within the Plasma Center is in compliance with facility SOP’s, state and federal
(FDA) Rules and Regulations, OSHA and CLIA requirements.
• Identify quality system related cGMP deficiencies. Develop, review and approve CAPA’s as well as verify
that appropriate follow-up and corrective action is taken to bring operations into compliance and maintain
sustainability.
• Execution, documentation, and review of internal and external audits.
• Create, review and approve Deviations utilizing Trackwise by applying rigorous problem solving and root
cause analysis.
• Determine donor suitability based upon regulatory requirements with robust record reviews and abnormal
tests results and initiating additional actions as required.
• Perform Look Back functions for abnormal test results and communicate with agencies in regards to donor
risk
Assisted in process validations and conduct equipment validations: IQs, OQs, PQs, and MQs.
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• Supervises the review of donor records, quality control procedures, supply inventory management,
proficiency testing and the calibration/validation and maintenance of equipment.
• Determines if quality activities and manufacturing records are in compliance with SOPs and regulatory
requirements, determines the need for corrective actions (CAPA), ensures proper documentation, and
determines effectiveness of the action.
• Provides support and assists other members of the Center Management Team in efforts to meet the center and
company goals.
• Management of Quality staff, including direction, assignment of work, development and training, and
delegation of tasks.
• Analyzes tracking and trending data, determine appropriate actions to improve trending and prepares reports
with in depth research and analysis to resolve systemic compliance issues.
• Hosted internal and external audits while maintaining compliance and quality standards.
• Recommended and implemented continuous quality improvement actions and analyze data for gap
assessments.
• Routine mentoring of all staff with emphasis on achieving a more in-depth understanding of tasks performed
and applications of cGMP.
• Continuously assessed, promoted and improved the effectiveness of the quality systems in the donor center
through recognition of trends, investigation of failures in the execution of procedures, direct employee
observation and review of center documents.
• Write, revise, develop, evaluate and review Standard Operational Procedures
• Demonstrate ability to maintain a high level of quality and compliance utilizing good judgment, analytical
skills, communication, problem solving and the management to balance multiple priorities with strong time
management skills.
Iredell-Statesville Schools, Statesville, NC
Rowan-Salisbury Schools, Salisbury, NC
Science / Biology Teacher (October 2003 – June 2007)
• Planned and instructed subject area of high school biology and middle grade science
• Developed and conducted inter-grade activities and specific learning modalities
• Implemented technology approaches to subject matter
• Guided cooperative instruction and various teaching strategies
Harmony Laboratories, Incorporated, Landis, NC
Regulatory Compliance Manger (December 1996 – April 2003)
• Provided direct and constant supervision for task performed by a staff of 25 laboratory technologist,
technicians and assistants.
• Ensured federal and state regulations, FDA Compliance, DEA Compliance, and cGMP were maintained and
identified areas of improvement
• Recognized and identified testing irregularities, equipment problems, error and potential problems that may
adversely affect test performance or results.
• Ensured all timeframes for problem reporting, corrective action plan development and the adequate
management of problem investigations is maintained.
• Participated in FDA Audits, and Conducted out-of-specification (OOS) and deviation investigations per SOPs
and FDA guidance.
• Contributed to the revision of SOP’s and batching record instructions.
EDUCATION:
• Cumberland College, Williamsburg, KY, BS, Biology and Health – May 1991
ADDITIONAL TRAINING:
• University of Louisville, Louisville, KY, MS, Physiology (1991-1993)
• University of Phoenix, Phoenix, AZ – Educational Courses (2004-2006)
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