Regulatory Compliance Specialist Through my diverse experience in Hospira and QualPak, I have become a dedicated and self-motivated individual that performs well under pressure and with extensive hands-on experience. Regulatory Compliance Specialist with 6+ years' experience driving quality initiatives for regulated emulsions, solutions, and medical devices. Extensive knowledge of cGMP, ISO, CFR and FDA regulations. Professional expertise experience with proficiency's in SAP, Trackwise, Continuous Process Improvement, Auditing, and Regulatory Regulations. Computer literate in Microsoft Word, Microsoft Excel, Microsoft Access, PowerPoint, and Complaint Management System processes. Manufacturing Quality Assurance Specialist cont'd Write exception reports, identify corrective actions, and perform investigations, as appropriate. SOP creation and updates, batch record review, and miscellaneous projects for Quality Management. Work well both independently and as a contributing member of a team. Excellent leadership skills, very professional and believe in strong work ethic.
Hospira, IncClayton, NC06/2014 to Current
Employee of the month November 2014 and received Make a Difference Award Implemented process improvement methods for the SVP Fill Room (Clean Room) and for packaging.
Completed all SOP revisions within deadline time frame for all three positions.
Quality Star Team Member at Hospira.
Received accomplishment cards from the formulation and packaging supervisors for preventing Exception Reports (deviations) in their respective areas and for going above/beyond the call of duty at Hospira.
Discovered procedures with the incorrect specifications; corrected them, and implemented the corrected procedures at Hospira.
Implemented a recycling program at QualPak.
Due to the initiation of the program, the company gained sustainable profitability.
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Drugs and Infusion TechnologiesRegulatory Compliance Specialist
Perform evaluations on APQR (Annual Product Quality Report) to ensure the Clayton APQRs are maintained in full compliance with Hospira' s policies and procedures.
Primary responsibilities include but are not limited to the following: Collect data from cross functional departments, write assigned APQRs, evaluate trends/shifts/areas of concern, summarize observations/conclusions, and provide recommendations for corrective actions as necessary.
Collaborate with senior management to obtain approval of the APQRs and initiate Trackwise records for corrective actions.
Assess CAPAs from previous APQR reports to assure corrective and preventative actions are sufficient for the nonconformance.
Perform internal audit inspections to assure site operations are in compliance according to site/corporate standard operating procedures as well as to cGMP, GDP/GLP, ISO, CFR and FDA regulations.
Support external audit activities.
Assist with quality initiatives, change controls, projects, and other activities assigned to the Compliance Department.
Designee for departmental change controls (creating/revising document changes) for SOPs (Standard Operating Procedures).
Assist with cross functional departments to complete required Compendial review and assessments.
Site head for Compendial Assessment Review Board Perform investigations and write exception reports for nonconformities/deviations for process operations and methods.
Write Medical Assessments for investigations when required.
Hospira, IncClayton, NC12/2011 to Current
Manufacturing Facility of Injectable.
Drugs and Infusion TechnologiesManufacturing Quality Assurance Lead Specialist
Provides leadership and training to three manufacturing QA specialists.
Acts as supervisor during the absence of the MQA Supervisor.
Performs real time review of the production batch records, and corrects any errors found.
Primary responsibilities include but are not limited to the following: Provides a quality presence on the manufacturing floor and supervise three MQ Specialists.
Responsible for the training of all new hires of MQ inspectors and any re-training to current inspectors.
Perform training seminars for Good Documentation Practices, Glass Defects, and any other product related trainings.
Oversee all online inspections, Settled Particulate inspections, and Re-inspections to ensure they are done according to Standard Operation Procedures and protocol guidelines.
Attend daily manufacturing meetings and communicate with the next shift lead to review shift pass down notes and any issues that may have occurred.
Collaborate with production supervisors to resolve any issues on the floor as they occur.
Perform compliance audits on daily operations, batch records, logbooks, manufacturing areas, and charts to assure they meet cGMP and quality standards.
QualPak, LLCLaurinburg, NCQuality Assurance Specialist08/2009 to 07/2011
Manufacturing Facility of Purell Hand Sanitizer & Hand Wipes Performs final disposition of batches and assures commercial batches meet cGMP and GDP standards.
Primary responsibilities include but are not limited to the following: Supervise 15 people to inspect finished good products for defects.
Perform daily batch record review, release and analysis on finished good products to assure products are properly implemented, conducted, and documented.
Perform interpretation and implementation on quality procedures and quality system.
Facilitate daily in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
Initiate deviations when documents, procedures, and finished good products were not followed or met according to specification's.
Participate and practiced good document control management, storage, and document review/revision processes.
Support internal and external audit activities.
Perform training seminars on Current Good Manufacturing Practices, inspections on in-coming components, finished good products, and CAPA plans were executed correctly and efficiently.
Attend daily manufacturing meetings and communicate with department heads to discuss day-to-day operations.
Bachelor of Science:Biology Environmental Science and ZoologyMay 2009The University of North Carolina, North CarolinaBiology Environmental Science and Zoology
Aug 2007Sandhills Community College, Pinehurst, North Carolina
charts, Documentation, senior management, frame, functional, GLP, interpretation, ISO, leadership and training, notes, meetings, next, packaging, policies, process improvement, processes, Quality, QA, real time, seminars, SOP, specification, Supervisor