Quality Assurance / Quality Control /Audits

Lcda. Maribelle Toledo Alemán, MBA

**** ** ***** *** *******, Fl 33025

Cellular: 787-***-****

E-mail: **********@*****.***

Objective:

Regulatory Affairs / Quality Systems / Quality Assurance / Quality Control position with Compliance responsibility at a Pharmaceutical, Medical or Consumer Products Corporation.

Summary:

Over 25 years of experience on Health Care Industry, focused on serving as a subcontractor to Pharmaceuticals providing consulting support on Regulatory Compliance, Quality Systems (APQR, CAPA, Stability Investigations, Internal inspection audits, Change Control, Regulatory Filings, gap analysis against Corporate Directives / Policies, among others), Quality Assurance (PAI, Computer System Validation CSV audits, SQM investigations, SOP training, and Corporate GMP Work Plan), Plan Support (Packaging Inspection, MBR review, BOM review, Incoming Inspections, Internal Manufacturing audits inspections, and SMED) and Quality Controls (Analytical laboratories, Stability, Validation, In Process, Raw Materials, Finished Product, Complaint, Method Transfers, Instrumentation, Chemical Plant, Technical Services, DEA, Microbiology Inspections). Flexible in responding to constantly changing organizational and market demands.

Experience:

Posada Data Systems, LLC Gurabo P.R (2006 to Present)

Vice President / Business Developer

In charge of all Posada Data Systems, LLC permission acquisition to operate in Puerto Rico. Responsible for the management of business products development for Posada Data Systems. Managed growth of company’s customer base by assisting in the implementation of strategies to facilitate long term relationships with new and existing clients. Impacted the profitability of the company and new business development results by ensuring appropriately focused strategic management decisions. Provided services as a subcontractor to major pharmaceutical companies. Other activities included improvements to ensure quality of services. Worked as Customer Service Representative (CSR) and Office System Administrator. Assisted the President as required.

Provided external consulting (Quality Assurance) service to Bristol-Myers Squibb Corporation, Humacao, P.R acting as:

Compliance Specialist – Stability / Quality Assurance-Plant Support (2013 to 2014)

In charge of all the BMS Stability activities as Quality Assurance contact between Lancaster (new testing facility), Corporate Headquarters – North America Stability (NAS) and Humacao operations. Activities included were Stability investigations, regulatory actions, Field Alerts, Stability APQR, evaluation and approval of annual stability sample commitments, approval of Stability data within AS400 system and Stability Protocol review. Also in charge of Marketed Stability sample tracking based on Annual Requirements, Stability meetings and assessment of Change Controls. Responsible of General Plant walkthrough audits. Managed different Quality programs such as APQR Report of various products, SOP’s evaluation, Specifications, Registrations, Internal Audits, and CAPA. Provide assistance in managing all aspects of regulatory filings intended for Government regulatory agencies such as CMC regulatory submissions, foreign countries registrations, certificates, etc and corporate inspections. Participated actively during inspections and audits including performing readiness exercises (before and during Inspection/Audits). In charge of Quality Systems, gap analysis against corporate Directives and Policies as well as handling of GMP regulatory observations, Facilities and Equipment, Materials, Production, Packaging/Labeling, and Laboratory Control Systems. Reported to Associate Directors of Regulatory/Compliance and Quality Assurance-Product Release.

Provided external consulting (Quality Systems) service to Bristol-Myers Squibb Corporation, Humacao, and P.R acting as:

Senior Quality Assurance Auditor and Compliance Specialist (2011 to 2012)

Responsible for the local procedure gap analysis against corporate Directives and Policies as well as handling of GMP regulatory observations. Performed impact assessment to applicable new, revised or draft Corporate Directives and Policies to ensure that Bristol-Myers Squibb (BMS)-Humacao is in compliance with corporate requirements and current regulatory trends. In charge of (Plant-wide and Quality Assurance) SOP’s improvement, changes, reviews, and the training process at the BMS site. Generated (or reviewed) Annual Product Quality Review (APQR) reports as requested. Reported to the Quality Assurance Regulatory Compliance Associate Director.

Provided external consulting (Quality Assurance) service to Mc Neil Healthcare, LLC Las Piedras, and P.R acting as:

Senior Quality Assurance Specialist (2011)

In charge of ensuring that Quality Systems were in accordance with GMP’s as per the Code of Federal Regulations and company procedures. Fulfilled Remediation actions in a timely manner during Consent Decree activities. Responsible for Master Data gathering to update SAP version from R3 to R6. Supported internal audits at Mc Neil Healthcare, LLC (Las Piedras site). Promoted to a QA Supervisor position. Represented the QA Manager in meetings and Projects.

Calibration, Validation & Research, Inc. (2007)

RA/QA Manager

Develop and implement the necessary Quality and Regulatory Systems for CVR Operations. Management of the Quality Systems start-Up, including improvements of procedures to ensure that Quality Standards were met during service delivery. Promote and facilitate compliance with ReComS Quality. Coordinate inspections of the organization and contract facilities. Work in coordination with the Operations Director to plan future activities and projects. Provided feedback to laboratory field technical personnel. In charge of keeping an adequate level of compliance. Ensured that all investigations were completed, and documented with scientific judgment. Interacted with clients, regulatory and health authorities throughout the development of services including support for any regulatory agencies (OCHA, EPA, and EHS). Activities included other related responsibilities as required according to the Operations Director and Business needs (Pest Control Program Management, Maintenance Facility Program Implementation, Administrative Assistance, and Customer Services Representative). Represented the company during regulatory inspections. Supported the implementation of ISO/IEC 17025:2005(E), 9001:2000 Standards Compliance within CVR operations. Reported to the Vice President of Operations.

Provided external consulting (Compliance) services to Janssen Ortho LLC (Gurabo, P.R) acting as:

Senior Validation and Compliance Specialist (2006 to 2007)

Conducted audits of Packaging Lines in order to identify areas of opportunities and to make improvements. Nine Packaging Lines were audited. Activities included but were not limited to compliance with internal procedures and GMP observations. Responsible for the Partial Packaging Master Batch Record (MBR) review that included shipper labels, inner labels, product inserts, Bill of Material (BOM), packaging carton and blisters. Improvements activities included SOP revisions, creation of new SOP’s with special working instructions check list for MBR review purpose.

Provided external consulting (GMP) services to Amgen (Juncos, P.R) acting as:

GMP Consultant (2006 to 2007)

Conducted audits on inconclusive supplier investigations. SQM (Supplier Quality Management) activities included but were not limited to verification of compliance with internal and external procedures, making GMP observations and direct contact with Medical Device and Packaging supplier.

Provided external consulting (Quality Assurance) services to McNeil Healthcare, LLC (Las Piedras, P.R) acting as:

Quality Assurance Specialist (2006 to 2007)

Conducted retroactive audits of inconclusive laboratory investigations. Activities included but were not limited to verification of compliance with internal and external procedures, making GxP observations and approvals.

Provided external consulting (Quality Assurance) services to Bristol Myers Squibb (Humacao, P.R) acting as:

Quality Assurance Representative (2004 to 2006)

Responsible for the approval of product report investigations, stability (A.P.R) revision, changes to manufacturing process methodology, execution of internal follow-up audits and pre-approval inspections (PAI) at a bulk manufacturing facility. Also responsible for the evaluation / acceptance of validation documentation (VMP, URS, FRS, IQ, OQ, PQ, Traceability Matrix) as issued by external contractors to ensure compliance with 21 CFR Part 11 ERS (Electronic Records / Electronic Signature) regulations. Approved validation protocols, reports and NC investigations. Scope of validation activities included computerized systems, hardware and software associated to laboratory equipment (chromatographic and non-chromatographic) for chemical analysis, microbiological and manufacturing applications. Example applications are Empower and NuGenesis. Assessed and followed up on the execution of a GMP Work Plan in response to Corporate Level Audit observations. Follow-up activities were handled using a TrackWise implementation of a (C.A.P.A) system.

Ceph, International Corporation, Carolina P.R. (2002 To 2004)

Stability / Validation / Instrumentation Supervisor

Management of the Stability, Validation and Instrumentation program (supervising 25 professional employees) with direct accountability on recruitment activities and personnel training program. Conducted internal audits of Stability System processes and implemented new methods of operation to increase efficiency. Created internal procedures to improve controls over Stability Laboratory documentation. Implemented improvement plan to evaluate data trends using statistical methodology that included comparative studies and historical data analysis. Certified and approved Stability protocols, schedules and analytical data on Stability System application to be compiled in reports (A.P.R.) for FDA submission. Recognized by management for quickly bringing Stability to a highly organized operation, keeping compliance with Federal Regulations and fast customer response. Successfully brought the Stability Laboratory from 90% to 5% backlog in one year with minimal resources. Responsible for the development of Validation and Instrumentation protocols and SOP’s. Provided recommendations to update analytical test methods. Conducted investigations of out-of-specification data and deviations with corrective/preventative actions (C.A.P.A) system where needed. Generated field alerts as well as deviation reports and warned management about regulatory issues. Supervised equipment maintenance activities such as qualification and calibration of HPLC and Dissolution systems, balances, timers and the environmental chambers including audits to supplier calibration documentation. Maintained direct communication with Corporate Regulatory Affairs, clients, visits and outside contractors. Became involved in regulatory agencies (FDA) inspections. Managed human resources issues that included absenteeism, quality situations, interpersonal conflicts, safety and employee evaluations. In charge of internal laboratory audit program, identifying non-compliance of systems, processes and practices, measured by number of observations. Achieved around a 30% improvement in GMP and GLP compliance as measured from subsequent laboratory audits. Supported financial functions by keeping detailed accounting of laboratory man-hours usage. Applied specific motivational techniques such as equal opportunities and employee vs. business needs negotiation to achieve total teamwork commitment toward laboratory goals. Participated in organizational meetings. Assisted the manager in special assignments.

Watson Laboratory Caribe, Inc., Humacao, P.R. (2001 to 2002)

Stability / Validation / Instrumentation Coordinator

Responsible of administering the entire Stability Schedule programs. Coordinated Stability and Validation Laboratory operations and training’s (total of 1 clerk, 3 chemists, and 3 technicians) with direct accountability of keeping compliance with Federal regulations and strict adherence to expected sample testing output. Reviewed and implemented improvement plan to evaluate data trends using statistical methodology that included comparative studies and historical data analysis. Certified and approved automated Stability Protocols, schedules and analytical data on Stability System application to be compiled in reports for FDA submission. Responsible for the development of the first new product Stability Protocol generated from P.R. to E.U. Created internal procedures to improve controls over Laboratory documentation. Supported investigations of out-of-specification data and deviations with corrective/preventive actions where needed. Generated field alerts as well as deviation reports and warned management about regulatory issues. Provided recommendations to update Sop’s and analytical test methods. Conducted internal audits of stability system processes and implemented new methods of operation to increase efficiency and ensure adequate control of data. Responsible for the coordination of equipment maintenance activities such as qualification and calibration of dissolution systems, balances, timers and the environmental chambers. Conducted supplier documentation audits. Keep direct communication with Corporate Regulatory Affairs and outside contractor’s services. Supported management during FDA inspections. Participated of recruitment activities. Supported financial functions by keeping detailed accounting of laboratory man-hours usage. Assist the supervisor in special assignments of administrative and managerial nature.

Schering Plough, Las Piedras, P.R. (1998 to 2000)

Scientist / Chemist QC/TS (Validation Laboratory /Technical Services Area)

As member of the GMP team, performed audits throughout the plant for the QA Lab., Microbiology Lab., Packaging Area and Incoming for GMP compliance. Performed audits, made recommendations, and in charge of updating the system for the administration of instrument calibration and qualification activities. Generated appropriate Y2K documentation for some instruments. Performed SOP’s update and created the GMP Training File for QC and QCIP areas. Worked with the CALMAN program, which manages equipment qualification, calibration and inventory records. Worked with JD Edwards’s program to generate and follow up purchases. Execution of Laboratory analysis (Validation Protocols, Method Transfers, Technical Services, Stability Program, In-process, Finished Products, Raw Materials, and QA) as per required precision and time management according to corresponding procedures, specifications and company standards. Performed work on instruments like Millennium 32, GC, FTIR, Ro-Tap, AA and Sonic Sifter.

Janssen Inc, Gurabo, P.R. (1996 to 1998)

Peer Reviewer Coordinator QA/QC/TS (Validation Area; 1997 to 1998)

Performed all the data verification and documentation ensuring compliance with SOP's, USP, PHEUR. Participated of manufacturing process optimizations at the analytical method validation level. Monitored validation activities for the evaluation of analytical method completeness, reproducibility and ruggedness. Provided analytical, statistical, and computerized support to Validation, Technical Services, QA, Chemical Lab and manufacturing operations. Coordinated analyst testing to ensure due date accomplishment. Provided constant support to the validation personnel. Responsible for new personnel training, management of the training file, corresponding documentation and assistance in cGMP’s areas. Performed audits to guarantee Stability Program proper sampling, updating of instrument calibration file to detect potential SOP deviations and to take proper corrective actions. Created new SOP for the management of analytical data.

Associate Scientist / Chemist QA/QC/TS (Chemical Plant, Validation Support; 1996 to 1997)

Provided support to the validation of new products, analytical method and product transfers. Carried out chemical analysis for validation processes, stability of drug substances, raw materials and production (API) at the chemical plant. Analytical equipment and techniques included Millennium HPLC, differential scanning calorimeter (DSC), TLC scanner and microscopy with video system.

Searle & Co, Caguas, P.R. (1985 to 1995)

Acting Chemist II QC (Automated Lab Cell; Finished Products 1994 to 1995)

Coordinated laboratory work and accountable for all laboratory test activities, data verification and product release authorization with the use of LIMS. Helped technicians on day to day activities and troubleshooting as group leader. Worked in a total quality team work oriented environment. Hands on experience with LIMS performing automated data acquisition, analysis, and sample database access. Performed training to the new personnel. Performed monthly reports and tabulated testing workload and its distribution by month for all the laboratories. Prepared statistical evaluation of data and cycle time tabulation.

Special Projects: Re-engineering

SMED (Single Minute Exchange of Dies)

Redesigned / modified production machines to dramatically reduce part exchange time from 70 minutes to 5 minutes which led to very significant machine downtime reductions and safety improvements.

Shipping area

Reduce to zero error the shipping product area with the implementation of recommendations originated from teamwork activities with the employees themselves. Total control of drug products handling was attained.

Chemist I (Special Projects re-engineering; 1993 to 1994)

Responsible for the conversion from old lab execution to the new cell-oriented organization. Managed all activities which included data collection, headcount projections, lab cell assignment, instrument relocation, new instrument acquisitions, lab cell organization by products, personnel preparation with training and meetings that facilitated the new work philosophy activities. Some results obtained included: accelerated handling of sample testing, physical space problem solutions identified at plant level and a faster response to the production area.

Chemist I (In-Process Laboratory; 1992 to 1993)

In order to be effective for processing and manufacturing operations, kept priorities on track of schedule. Received sample of in process, activated testing and coordinated laboratory analysis. Managed investigation of unusual analytical results as per company SOP’s. Effectively administered document system at the laboratory area by ensuring timely update of chemical test methods and SOP’s with occasional issuance of document change requests.

Chemist I (Stability Laboratory; 1987 to 1992)

Received marketed and accelerated protocol samples, prepared sampling schedule plan, coordinated laboratory work test results verification, and tabulated data for the NDA’s final report to establish the expiration date of the product. Periodically updated the Stability Control File based on information from the Manufacturing Batch Records. Accountable for all lab activities, audits the QC laboratory including handling of controlled substance products, for DEA inspection. Responsible for the analysis of the finished goods as scheduled by marketed and accelerated studies using a wide variety of instrumentation such as GC, IR and KF. Performed instrumentation troubleshooting operation, calibrations and preventive maintenance of equipment.

Special Projects

New work philosophy: Manufacturing Excellence across plant

Created our own work philosophy based on our work place needs, conducted presentations and training throughout the plant and worked hard in the implementation of the new philosophy.

Analyst (Validation Laboratory; 1985 To 1987)

Performed chemical analysis of samples for the certification of new raw material vendors, complaint evaluation and method transfers. Analytical equipment and techniques included UV/VIS, HPLC and Dissolution Apparatus.

Skills:

Knowledge of Statistical Process Control (SPC) concepts, cGMP, GLP’s and other regulations.

Bilingual: English / Spanish, Results oriented with careful attention to details.

Team player, strategic thinker, capable of growth and increasing responsibilities.

Self-starter, hard worker, well organized, with excellent problem solving, communication and documentation skills.

Strong people skills, solid leadership capabilities, able to handle multiple priorities and projects. Flexibility to cope with changes and able to work with limited supervision.

Knowledge of computerized systems, e-mail (cc: mail, Lotus Notes), Stability System application, LIMS, COSMOS and DCA system.

Other Courses, Seminars and knowledge:

Basic Supervisory Course (UPR Campus). Managerial experience / leading teams.

21 CFR 210, 211, 11, 820.

(CQE) Engineering Quality Certification, Quality Advisors and Team Leaders.

cGMP- Laboratory Controls for Drugs, Health and Safety in operations involving hazardous waste.

Word Perfect, Lotus 1.2.3., Window XP, Window 2010, MS Word, MS Excel, MS Power Point, Ubuntu 14.04 LTS

Just In Time & Total Quality, ISO 9000, ISO 9001:2000, ISO/IEC 17025:2005(E), ISO 13485:2003.

GC, HPLC and SMED seminars

Lean Manufacturing, Six Sigma, Root Cause Analysis and FMEA.

Professional Designation:

Puerto Rico license # 2999

Board Of Examiners Of Chemists

Education:

BS, Bachelor of Science, University of P.R. (Humacao Campus) Major: Industrial Chemistry.

MBA, Master of Business Administration, University of P.R. (Turabo Campus); Major: Management.

DBA, Doctoral of Business Administration, University of P.R. (Turabo Campus); Major: Management (18 approved credits).

Hobbies:

Lectures of motivation and life style philosophies.

Awards:

1992; "Administración de Control de la Calidad y Herramientas Estadísticas para el Mejoramiento de la Calidad”, Searle & Co.

Acknowledgments:

1997; “Promoting Team Work and Document Assistance”, Janssen, Inc.

2000; “Updated the Manual Instrument File, Calibration and Qualification of the Instrumentation Area”, Schering Plough.

2005; ”Recognized by management for quickly bringing Stability to a highly organized operation”, (Good Performance), Ceph.

References:

Professional references available upon request.

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