Maria C. Eckhardt

***** ********** **., *****, ** 33624

Ph: 813-***-****

e-mail: ac1ki4@r.postjobfree.com

PROFESSIONAL SUMMARY

Hands-on Quality Professional with over thirty years of combined experience in highly regulated cGMP industries at Contract Manufacturing and Private Label Organizations responsible for manufacturing and release to market of multiple dosage forms: Tablets, Soft Gelatin Capsules, Liquids, Biopharmaceuticals, Injectables and Dietary Supplements.

Robust knowledge in all aspects of GMPs as it pertains to the manufacturing, storage, testing, release and distribution of Pharmaceuticals, Bio-Pharmaceuticals, OTCs, and Dietary Supplements (CFR Title 21, Parts 210, 211, 111, 11, 820), as well as, various Testing Compendia (USP, EP, JP).

Strong hands-on and regulatory experience in QC-Analytical, Microbiology and Quality Assurance.

Solid knowledge in implementing and managing Quality Systems: Training, Investigations and Root Cause Analysis, Complaints, Corrective and Preventive Actions (CAPA)/Effectiveness checks, Change Control, Annual Product Reviews, Stability Program, Batch Disposition, Supplier Qualification Program. Effectively supported and managed New Products Introductions by meeting on-time project deliverables.

Developed and implemented robust procedures to support Corporate Quality Policies.

Responsible for conducting and/or participating in regulatory Audits by FDA, MHRA, Turkish Authority, ANVISA, Corporate and customer cGMP Audits, as well as, PAI Regulatory Inspections.

Effective communicator and mentor. Customer and results oriented professional that works well under pressure and gains the support of others.

Quality representative in implementation of Lean Initiatives such as, clean desk policy, QC/QA 5S, Visual Board, SQDC boards, GEMBA program, Visual Batch Record, as well as, Kaizen events for manufacturing and engineering processes optimization. Participated as the Quality SME to support implementation of J.D. Edwards across multiple sites at a global CMO.

WORK HISTORY

Associate Director of Quality May 2016-Present

Virtus Pharmaceuticals, LLC. Tampa, Fl.

Responsible for supporting operations of drug products at contract manufacturing organizations (CMO) and contract laboratories organizations (CLO).

Responsible for all issues related to regulatory quality and compliance including setting-up and overseeing cGMP programs for manufacture and distribution of drug products, OTC, nutritional supplements.

Responsible for interacting with departments within the company and its CMOs & CLOs to critically evaluate quality systems to support continuous process improvements.

Responsible for supporting new product projects for successful and timely launches. Interact and coordinate with internal and external parties all quality related activities and obstacles resolution.

Responsible for internal and external regulatory compliance Audits in accordance with procedures.

Responsible for the operation and maintenance of Internal, CMO and CLO Audits, Audits schedule, writing and/or approving Audits reports.

Responsible for identifying, tracking, reviewing/approving CAPAs generated from the different QMS internally and externally.

Change Control management (documentation, equipment and process), Complaints, Investigations, Training, Annual Product Review (APR) program and review and approval of APRs, Process and Cleaning Validation protocols and reports.

Quality Agreements preparation, negotiation and approvals.

Oversight of CMO manufacturing including, but not limited to, executed Batch Record review and approval, assessment and approval of deviations, Change Controls, laboratory Investigations, and analytical data, among others. As well as, responsible for Lot Disposition activities based on regulatory requirements.

Support product recall activities.

Author, and/or review and implement SOPs, protocols, compliance documents, etc.

Responsible for preparation and presentation of company Quality site metrics in support of management review, as well as, working with counterparts to drive continuous improvement.

Support Regulatory authority (FDA, State of Florida) inspections, as needed.

Achievements: from the ground up, built the Quality Assurance Department by hiring qualified professionals, implementing Standard Operating Procedures and metrics to document and track all related activities for complaints, Change Control, Batch Record review, Lot Disposition, Quality Agreements, Investigations, Audits, annual product review, Stability, CAPAs, Validations, among others. Established individual’s goals with the objective of eliminating and/or preventing backlogs. Significantly improved relationships between the Quality Departments at CMOs and Virtus Pharmaceuticals.

Quality Assurance Director June 2015- February 2016

Florida Biologix, Gainesville, Fl.

Center of Excellence for Regenerative Health Biotechnology

University of Florida

Identified and implemented the development, maintenance and continuous improvement of cGMP quality/compliance systems and procedures. Provided Leadership and directed the department activities regarding quality systems, training, raw materials release, final batch release and disposition, non-conformances, deviations, Investigations, complaints, CAPA and effectiveness checks, regulatory compliance, Change Control, equipment and facilities Validation, assay qualifications, Stability program. Responsible for the Quality review/approval of technical documentation related to manufacturing records, specifications, Change Control, Validation protocols, QC methods, Stability, among others.

Responsible for preparation and presentation of company Quality site metrics in support of management review, as well as, working with counterparts to drive continuous improvement.

Provided leadership and support, as the site Quality Head, for all cGMP manufacturing and quality control activities. Responsible for daily support to manufacturing, warehouse, and supply chain operations, facility and equipment. Direct Quality support to external customers.

Provided quality guidance, decision-making and responsible for timelines in matters related to Quality in support of the projects.

Hosted client and regulatory agency Audits, as well as, managed the internal Audits program. Responsibilities included Audits preparation, Audits execution, post Audits reviews and assignment of Audits responses and tracking and closure of the corrective actions for compliance.

Achievements: Provided leadership within the QA Department and other departments by mentoring and assigning responsibility and accountability. Contributed in the implementation of a GMP culture at the site by working with other Directors, Upper Management, and individual contributors. Improved the following processes by eliminating redundancy and enforcing optimized SOPs: Change Control, Investigations and deviations, Root Cause Analysis, CAPA identification/implementation, Batch Record review, documentation practices, among others.

Quality Assurance Manager January 2008- May 2015

Catalent Pharma Solutions, Saint Petersburg, Fl.

Quality Assurance liaison for customer’s commercial line and designee in Projects to support R&D and New Product Introductions. Responsible to support all Manufacturing, QC/Microbiology Laboratories, R and D, Engineering, Validation, activities in support of assigned customers.

Provided leadership and managed the site Quality Systems: Change Control, training, complaints, Annual Product Reviews, planned and unplanned deviations, among others, in support of assigned customers and their products.

Participated and provided leadership, as the Quality subject matter expert, in Regulatory Inspections and Customer Audits for the products and customers assigned. Responsible to coordinate Audits responses and implement corrective actions.

Responsible for the Quality review/approval of technical documentation related to manufacturing records, specifications, QC testing methods, QC methods qualification/Validation, laboratory equipment qualifications, manufacturing equipment Validations, critical systems and facilities qualification/Validation, Change Control, Validation protocols, Stability studies, Investigations, CAPAs, complaints, among others.

Preparation of internal and external metrics for periodic Management and Business Reviews.

Authored and/or approved and maintained detailed Standard Operating Procedures (SOPs) defining the site Quality Systems as required by site initiatives, company policies, and corrective actions.

Subject matter expert in the TrackWise, Documentum, ComplianceWire software and other Quality driven software platforms, as well as, managed site Administrators.

Achievements: Mentored and developed IPQA floor personnel on Quality-based decision making to effectively and consistently support Manufacturing and other Departments. Improved SOPs by clearly assigning responsibilities and providing clear instructions. Cross-trained staff on different functions within the Quality Unit to effectively support business demands. Implemented effective CAPAs, across the organization, by conducting proper Root Cause Analysis in investigation. Coached and mentored staff by promoting their participation in process improvement activities, internal Audits, and managing products and customers. No project delays caused by the QA department.

Quality Control Manager-Support Team June 2007-December 2007

Catalent Pharma Solutions, Saint Petersburg, Fl.

Responsible for managing the Microbiology Lab, and the Analytical Team supporting testing and on-time release of all excipients, Gelatin and packaging components in support of manufacturing.

Responsible for the Quality Control testing of critical systems: city and softened water, USP Purified Water, Compressed gasses, Environmental Monitoring Program for the Facility.

Responsible for the on-time release of all materials, components.

Responsible for the writing and/or reviewing of all related Investigations for the Microbiology and QC Support Team.

Achievements: reduced back log for raw material testing by 60% in less than 4 months by cross Training analysts, improving procedures and methods, scheduling activities, assigning accountability, and developing staff in investigation writing, proper Root Cause Analysis and effective CAPAs.

Quality Control Manager-Microbiology May 2000-June 2007

R.P. Scherer/Cardinal Health, Saint Petersburg, Fl.

Worked closely with the lab Group Leader to ensure smooth operation of the lab on a daily basis, as well as, supporting the Team for proper conflict resolution and employee growth.

Subject matter expert for all Microbiology related issues and initiatives in support of site improvements and customer, corporate and regulatory Audits.

Worked closely with Management in implementation of lab improvement initiatives.

Achievements: effective implementation of work schedules, clear work instructions and SOPs, and cross Training of staff to empower employees to work independently on daily tasks. As well as, empowering the Group Leader to make certain level decisions.

Microbiology Supervisor January 1993-May 2000

R. P. Scherer, Saint Petersburg, Fl.

Supervised all daily activities in the Microbiology laboratory and prepare daily/weekly/monthly work schedules for the lab staff.

Served as the Microbiology SME during customer and regulatory Audits.

Responsible for responses and corrective actions pertaining the Laboratory.

Prepared monthly trends and reports for quarterly Management Reviews and presented information.

Achievements: introduction of a Product Matrix approach used in supporting qualification of Microbial Limit Testing, as well as, implementation of a qualified Environmental Monitoring Program. Implemented a rotational cross-Training approach aiming at all Microbiologist being 100 % trained in all Microbiological techniques and tests within a year of hiring.

Microbiology Director June 1991-January 1993

Veridien Corporation, Tampa, Fl.

Established the Microbiology Lab from scratch, order all equipment and wrote applicable Standard Operating Procedures and testing Methods.

Responsible for reviewing and interpreting testing guidelines and requirements set forth in the AOAC (Association of Analytical Chemist).

Supervised all activities and staff in the Microbiology lab on a daily basis and served as a liaison and subject matter expert.

Microbiologist January 1986-May 1991

R.P. Scherer, Saint Petersburg, Fl.

Responsible for testing and reporting results of the microbiological analysis of nutritional and Rx APIs, excipients, purified and soft water, finished product, environmental air and surfaces, among others.

Microbiology Lab Technologist April 1987-May 1995

Laboratory Corporation of America, Tampa, Fl.

Plating, reading and reporting of patient samples.

EDUCATION

Total Quality Management Certificate, University of South Florida, Tampa, Fl.

Bachelor of Science-Microbiology, University of South Florida, Tampa, Fl.

Bachelor of Arts-Education. Universidad Catolica Andres Bello, Caracas, Venezuela.

PROFESSIONAL MEMBERSHIPS, SEMINARS, SKILLS

Affiliations: American Society for Microbiology (ASM), American Society for Quality (ASQ).

Total Quality Management Certificate (University of South Florida).

Microbiological Monitoring and Control. Institute for International Research.

Design of a comprehensive Environmental Control Program. PDA Conference.

Implementing QA/QC in the food Microbiology Laboratory. ASM Convention.

Quality Auditing of a Microbiology Laboratory. ASM Convention.

Indoor Air Quality. ASM Convention.

Disinfectant Testing, Current topics in the evaluation of disinfectants and Antiseptics. ASM Convention.

Proficient in Computers and software applications: EXCEL, WORD, Power Point. Enterprise Systems: GLIMS (Laboratory Management Systems), JDE (JD Edwards), Trackwise, Documentum, Compliance Wire, among others.

Excellent written and verbal communication skills both in English and Spanish.

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