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Quality Training

Silver Spring, MD
September 14, 2018

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Silver Spring, MD ***** ~ 919-***-**** ~

Summary of Qualifications

As an Experienced manager with expertise in human relations, pharmaceutical quality manufacturing, and project management I possess an extensive knowledge of the following Federal and state Employment law, Staff training/development, Organizational and Strategic Planning, Management Coaching, Contract negotiation, and Compliance.

I possess a combination of thirteen years of GCP,cGMP,GLP, Administration Lead, Pharmaceutical and Quality Assurance experience as a Professional in the Pharmaceutical Industry.

Impeccable HR management, documentation, written/oral communication, organizational, and attention to detail skills with a Proven track record of working well independently as well as part of a larger team.

Technically proficient with Millennium, Microsoft Office suite, Word, Microsoft Windows, Access, Excel, Track Wise, Power Point, EStar, and Empower

Education and Certificates

MS, Human Resource Management, American Intercontinental University, Atlanta, GA

BA, Liberal Arts/Psychology, Fayetteville State University, Fayetteville, NC

Lean/Six Sigma Green Belt Certification, North Carolina State University

Certificate of Bio Processing, Wake Technical Community College

Certificate for Ophthalmic Technician, Fayetteville Technical Community College

Fundamentals of Fermentation Engineering (Professional Development Course), NC State University

Currently enrolled in CQA Certification Course

RAC Regulatory Affairs Certification via DoD

Professional Experience

Planet Pharma (Contract) Sucampo Rockville MD. June 2017-Current Sr. Quality Assurance Specialist Contractor Under the direction of the Director of Quality Assurance, as a Quality Assurance Consultant I develop and maintain the corporate standard document control system, CAPA/deviation tracking, audit documents, and training records, as well as provide overall support to the Quality department. Manage and perform internal and external audits of studies, programs, processes, and systems to assure compliance with appropriate cGMP/GDP/GCP/GLP/GVP/computer validation regulations, guidelines, and standards. Manage Product complaints day to day activities, maintain database and generate quarterly reports.

Oversee corporate standard document control system to include tracking, issuing, distributing, formatting, and quality control (QC) of SOPs, work instructions, forms, reference documents

Assist functional areas in developing and implementing global/regional processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards

Develop and coordinate internal audits to ensure compliance to all relevant policies and procedures. by issuing audit reports and the facilitation of timely closure of corrective actions.

Perform audits of clinical sites, vendors against GCP/cGMP standards, FDA requirements and other regulatory standards and ensure resolution of any identified issues.

Perform external audits of suppliers/vendors

Review complaints and quality event documentation for accuracy. Prepare responses to customer audit findings in a timely manner to ensure compliance in accordance with SOP requirements.

Oversee/develop the employee training program including assessments and its effectiveness. Train new hires in orientation.

Maintenance and audits of corporate training records and training curricula.

Stay current on industry quality best practices.

Coordination, development, and preparation of training materials (e.g. PowerPoint presentations) and training sessions (e.g. audio-conferences)

Identification, communication, and scheduling of training opportunities and/or training notices.

Review and update SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGMP standards, FDA and all competent authority regulations and requirements.

Implement GCP Quality Assurance programs for the conduct of clinical trials and clinical study reports.

Generate metrics and trend reports. Identify and mitigate gaps.

Responsible for manufacturing and laboratory CAPA, deviations, investigation report reviews and final dispositions.

Paragon Bioservices Baltimore MD. August 2016-June 2017

Sr. Quality Assurance Training Coordinator

As a Senior QA Training Coordinator for Paragon BioServices my responsibilities consisted of the training of more than two hundred individuals and the management of the Quality System Training Program of a CDMO performing research, process development and GMP manufacturing of phase I/II Biologic bulk drug substances and sterile finished products. I handle all day to day management of the training tracking systems, as well as serving as the primary resource for Pre-Clinical and GMP Personnel managing their training in conjunction HR and upper management. I was required to interact with individuals at multiple levels within all functional departments at Paragon. I developed training and training presentations on relevant topics, ensuring complete understanding/ proficiency, and remedial training where needed. I was also responsible for maintaining the life cycle of the Quality System Training Program and evaluating for continues improvement, all while demonstrating a positive, professional approach toward work and a willingness to cooperate with co-workers and supervisors and contribute to project

Manage Paragons training and Tacking System

Provided strategic oversight of the training program.

Work directly with all levels and departments to establish training curriculums.

Develop and deliver training presentations on pertinent topics to large groups.

Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding

Maintain a system to track and required training and qualifications.

Evaluate, develop and implement improvements to current training tracking system.

Support FDA, EMA and client audit inspections

Perform internal Audits

DoD Fort Detrick USAMMDA (Tunnell Government Serv.) Frederick MD Jan 2014-Aug 2016


As a QA specialist for USAMMDA Fort Detrick, I’m responsible for the auditing, maintenance, and implementation of Quality Management Systems throughout the US and other countries. I serve as an internal/external GMP,GCP auditor interacting with (IPT) Integrated project teams in all departments throughout USAMMDA, ensuring appropriate documentation, reporting and closure of clinical and manufacturing compliance issues. I provide guidance to clinical operations and data management, ensuring appropriate systems and procedures are in place to comply with regulations, guidelines, study requirements and Army Regulations. I also oversee the escalation of compliance issues to QMO, QA Management and relevant department management by providing guidance, interpretation, support, training, and input on GCP, GMP, GXP and cGMP regulations along with company and Army regulated policies.

Participate in the execution of the Clinical and Nonclinical Vendor Qualification and Management program.

Conduct QA audits of CRO’s,clinical and regulatory vendors.

Conduct internal audits of the Clinical departments, Training and Regulatory Affairs department to verify adherence to GCP, GMP, GLP, AR’s (Army Regulations), and company procedures.

Perform trending analysis of audit findings and provide reports to management.

Review IND Submissions and audit IND submittal process

QA on IPT teams as a reviewer of stability documentation for use in IND submissions

Review and author AR’s, SOPs, WPD and other clinical and regulatory documents as required.

Conduct Quality reviews of records and reports from clinical, non-clinical studies, IND’s, and NDA’s.

Conduct clinical investigator site audits. Generate audit reports and evaluate CAPA effectiveness.

Currently heading up the implementation of a new electronic Training management system.

Manage the training systems for all USAMMDA departments CSSD and DRAC.

HJF Henry M Jackson Foundation - Bethesda, MD April 2013 – August 2013


As a member of the HJF (DAIDS) Division of AIDS Quality (VTRB) Vaccine transitional Research Branch I was responsible for handling confidential company projects and information while overseeing the quality of the production and manufacturing of clinical trial vaccines for treatment of HIV. I was required to maintain an in depth product knowledge of all HIV Vaccine products sponsored by NIH NIAD DAIDS and maintain an up-to-date understanding of clinical trial studies associated with DAIDS backed products to conduct site visits and assure current good manufacturing practices (cGMP) and adherence to all federal guidelines. I would often provide recommendations for grant funding and efficacy trials while managing current contracts, based on my understanding and knowledge of the pharmaceutical field.

Conducted approval meetings with Doctors and Scientist daily to discuss funding of projects and other contractual concerns.

Reviewed multiple companies’ procedures for Contract and Grand awardees.

Scheduled, hosted, and conducted site visits.

Plan and conduct internal clinical process audits according NIAD

Project management, Grant management, Document Batch, and Contract Review.

Audited clinical trial sites and vendors in developing countries such as Africa and Asia and Brazil.

Merck Pharmaceutical Durham, NC (Sunrise Systems) May 2012- April 2013


As a valued member of the Merck Quality Assurance Management Team I was a direct report for a total of eight QA Specialist with my direct report being Merck’s QA Director. I was responsible for collaborating with QC, Engineering, and Validation areas to assist with protocol creation and validation plans. I was also responsible for hosting and assisting with regulatory inspections and handling any potential problems noted during the inspection. I would follow up with internal and external quality audits to assure all manufacturing departments and sights are in acquiescence with corporate documented procedures as they relate to the ISO, GMP, and cGMP standards. To insure complete improvement and enhancement of the organization I collaborated in the launching of process management systems, to include; documentation of location processes/procedures, training of personnel, and the implementation of quality management systems.

Attended and presented at company monthly and quarterly VP updating meetings, Preparations of summary reports of audits to present findings to Senior Management.

Scheduled, prepared, hosted, conducted, and documented assigned audits of the Company’s projects and operational processes in accordance with approved procedures, schedules, and formats.

Conducted investigations to troubleshoot and resolve issues with batch work. And made recommendations for process improvement based on audit results.

Identified training gaps and address with appropriate departments, Hosted and developed training materials and presentations for new employees.

Developed Quality Managing System to ensure that facility and projects were in compliance with Good Laboratory (GLP) and current Good Manufacturing (cGMP) practices.

HIGH TECH COMPUTER CORP (HTC) Cary, NC March 2011- May 2012


As a leader of High Tech Computer Corp’s (HTC) HR department I was expected to instill confidence in employees that their inquiries were being heard, recorded, and responded to in a timely and quality manner. I assisted in the development and implementation of personnel policies and procedures. I maintained HR staff job results by counseling and disciplining employees; planning, monitoring, and appraising job results. I was responsible for maintaining employee benefits programs and informing employees of benefits by studying and assessing beneficial needs and trends, then implementing the necessary benefit programs to ensure compliance with federal and state regulations. I handled employee relations counseling and exit interviews, evaluated, accepted/awarded benefit contract bids, designed, and conducted training and new hire benefit programs.

Saved company $126,000 in annual benefits costs by recognizing need to tailor insurance plans as employee pool grew and assessing employees’ top concerns and needs regarding coverage.

I was appointed the task of creating and implementing benefits packages for sixty plus employees and creating new hire packages within two months of being hired.

Coordinated off-cycle compensation process, targeting critical talent for bonuses, base salary increases, and other incentives to ensure retention of top employees.

Designed, developed, and implemented curricula, courses and programs to support company quality training.

Wyeth Pharmaceuticals – Sanford, NC May 2004 - March 2011


As a lead member of the Wyeth team I assisted in launching a startup facility from beginning to end by creating SOP’s and developing site wide trainings. I also created engineering protocols for the validating processes and additional SOP’s for manufacturing equipment and process procedures. I assisted a great deal in the introduction, training and implementation of the EBR in to our manufacturing processes, Participated In a total of four FDA and European Audits during my time at Wyeth earning me continuous promotions within the organization allowing me opportunities to transition from Lead Bioprocess Technician to Document Control Specialist /Trainer and then Quality Control Auditor. I was lead for a team of 20 highly trained technicians, my duties included evaluating employees routinely and ensuring standards of performance are met within the manufacturing group and keeping personnel informed and up to date records on all training requirements, deadlines and milestones that are to be met during our time on site. I delegated responsibilities to supervisors and individual in various departments, such as Fermentation, Media Prep, Purification, Recovery, and Buffer.

I was able to save my company money and reduced losses by creating and implementing a material management first in-first out (FIFO) system, cutting materials expenses by 8% in the first year and saving the company a total of 1,254-man hour's yearly.

I implemented Quality Management System to include corrective action and documentation of process Managed ISO 9001: 2000 activities, including formation of corrective action procedures.

I analyzed and interpreted project study investigation results and served as a member of the Logistics team.

I reviewed Certificates of Analysis (C of A), Certificate of Conformances (C of C) and any additional documents requested by clients.

Analyzed production budgets and made changes as necessary throughout the production process.

Additional Training And Skills

Hiring, Human Resources Management, Benefits Administration, Performance Management, Communication Processes, Compensation and Wage Structure, Supports Diversity, Classifying Employees, Employment Law, Laws Against Sexual Harassment, Organization hire

ISO/IEC General Requirements for the competence of testing and calibration laboratories (17025) Medical Devices, Risk Management (14971), Quality Management Systems (13485), 21CFR parts cGMP In Manufacturing Processing, Packaging or Holding of Drugs (Part 210) cGMP For Finished Pharmaceutical’s (part211), Quality Systems Regulations (part 820) Biological Products (part 600) Application for FDA Approval to Market A New Drug (part 314) and other GMP regulations.

Leadership Skills: Success through Teamwork, EOJT (on the job trainer), Disaster Recovery planning

Time Management Essentials, Critical Thinking and Problem-Solving Communication Skills, Assertiveness Skills, Communication Skills, Strategic Thinking for operational Management and Strategic Planning and Implementation

Integrity; sense of fairness; ability to converse comfortably with people of all education levels; communication skills; negotiation skills.

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