SUMMARY:

• A Quality professional with over twenty years’ experience in Pharmaceutical and Biotechnology industries.
• Expertise in pharmaceutical, biological and vaccine manufacturing of parenteral drugs and solid dosage form products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance.
• Implemented continuous improvement initiatives, quality systems, aseptic techniques and method transfers.
• Generated and validated analytical methods and procedures. Conducted comprehensive evaluations and audits; performed gap analysis, batch record reviews, annual product review, deviation investigations and Corrective/Preventive Actions (CAPA) implementations.
• Familiarity with large scale manufacturing, current Good Manufacturing Practices and US / EU regulations: 21 CFR Part 11, Part 210, Part 211, Part 600, Part 601, Part 610 and ICH Q7A.
• Have participated in remediation of regulatory actions (warning letters and consent decrees) and acted as CAPA team member.
• Also, a Quality System Auditor with over two years in Medical Device and responsible for conducting GMP audits in support of Quality Systems Audit Program. These audits included, but are not limited, to investigating and reviewing compliance to 21 CFR Part 210, Part 211, Part 820, Part 801, Part 803, Part 806, ISO 13485, ISO 14971, ISO 19011 and all pertinent industries policies and procedures.
• The position directly responsible for ongoing maintenance and continuous improvement of this audit program.
• As QS Auditor assisted with inspection activities (preparation, conduct, and responses) for Quality System inspections required by the Quality Systems Audit Program, which included auditing manufacturing sites, distribution centers and supplier sites quality system functions encompassed at various different companies facilities.
• Have participated in audit inspections as Quality System Auditor in Medical Device companies in response to FDA 483s.
• Provided Quality Assurance Management in the remediation of regulatory actions (warning letters and consent decrees) and acted as CAPA team member.

SPECIALIZED:

• Leadership Effectiveness.
• Critical Problem Solving.
• Effective Communication.
• How to Manage Multiple Projects, Meet Deadlines & Achieve Objectives.
• Practical HPLC Troubleshooting.
• Negotiating Skills.
• 21 CFR Parts 11: Scope and Applications.
• Performance Management.
• Good Laboratory Practice.
• Current Good Manufacturing Practice.
• Fundamental and Advanced Dissolution Testing and Advanced HPLC Methods Development.
• Systems and Process Validation Fundamentals.

SKILL:

Regulatory complianceDeviation/Investigation/CAPA Reports

Process Analysis / Quality ControlAseptic Techniques/Clean Room

QC Line Operations Quality on the Floor

Product Release (batch records and lab reports)Biotech/Vaccine Processing

Lab/Clean Room Equipment MaintenanceFiling line Operations

Packaging/Labeling review Auditing / Inspecting

EXPERIENCE:

Confidential, ARDSLEY, NY

Sr.Quality Engineer

Responsibilities:

• Perform Manufacturing/Deviation/Non Conformance Investigations.
• Perform Complaint investigations and CAPA Deviations.
• 1nitiated CAPAs, assigned responsibilities, and follow - up for completion.
• Attend weekly meetings to assess status of the investigations and CAPA Review Boards.
• Communicate/Escalate to management of issues for immediate attention to revise and update SOPs to comply w/ cGMPs and other regulatory requirements.
• Participate in the review of documents for product release (commercial/clinical).
• Review regulatory documents to support commercial and clinical materials release (e.g. Batch records).
• Perform product and Annual Product Review.
• Perform change control and revise SOPs.
• Perform audits of Contract Manufacturing Organizations (CMO) including packaging sites for pharmaceutical products (oral dosage, liquid suspensions) and medical devices.
• Qualify and audit vendors and suppliers to ensure compliance with quality regulations, standards and metrics...
• Established Quality Assurance Agreements (QAA) with suppliers as needed.

Confidential, ST LOUIS, MO

QA Investigator

Responsibilities:

• Performed Manufacturing/Deviation/Non Conformance Investigations.
• Performed Complaint investigations and CAPA Deviations.
• Identified trends, root causes and wrote investigation action plan as applicable.
• Reviewed and verified supporting documents and data for accuracy and completeness.
• Wrote summary investigation reports with root causes as applicable.
• Worked with cross functional areas to determine the root cause/s and corrective and preventive actions.
• Reviewed investigation reports for accuracy and completeness.
• 1nsured that investigations were completed in a timely manner as required per site SOPs.
• 1nitiated CAPAs, assigned responsibilities, and follow-up for completion.
• Attended weekly meetings to assess status of the investigations and CAPA Review Boards.
• Communicated/Escalated to management of issues for immediate attention to revise and update SOPs to comply w/ cGMPs and other regulatory requirements.
• Participated in the review of documents for product release (commercial/clinical).
• Reviewed Production Batch Records/Laboratory Batch Records for product release.
• Performed Annual Product Review.
• Participated in remediation activities of CAPAs in response to FDA 483s.

Confidential, WALTHAM, MA

Quality System Auditor

Responsibilities:

• Responsible for conducting GMP audits in support of the Corporate Quality System Audit Program.
• Scheduled, planned, conducted, and led audits in accordance with Corporate QS Audit Program.
• Ensured audit activities were in compliance with company procedures and regulatory requirements.
• Disseminated audit findings to senior management as required by Corporate QS Audit Program.
• Provided extensive regulatory expertise as needed to support QS improvement initiatives.
• Developed and created audit reports, coordinated action plans and follow up with auditee to assure prompt and adequate completion of agreed upon actions.
• Established and conducted sectional readiness for FMC RTG sites and QS functions.
• Served as GMP subject matter (SME) for regulatory Inspections, investigations and CAPAs as needed.
• Created, revised, developed and reviewed standard operating procedures used for GMP auditing.
• Performed any other tasks as requested by Management to support quality oversight activities.
• Helped development and reporting of any quality and compliance metrics related to audit activities.
• Led contracted 3rd party audit activities used for supporting the Corporate QS Audit Program.
• Coached/mentored staff as a means to ensure performance and .
• Established/maintained the effective cross-functional team communications to advance FMC quality activities.
• Coordinated completion of quality questionnaires with suppliers.
• Evaluated suppliers' responses against FMC Quality Systems and provided recommendations for material approval.
• Completed material approval documentation and updated FMC Approved Material list as needed.
• Performed Quality Risk Assessments as needed.
• Established Quality Assurance Agreements (QAA) with suppliers as needed.
• Performed medical device remediation and new product development projects.
• Reviewed and analyzed on market product complaint data and identify risk controls.
• Have good knowledge in design and manufacturing process.

Confidential, DAYTON, NJ

QA Investigator

Responsibilities:

• Performed Manufacturing/Deviation/Non Conformance/ Complaint Investigations.
• Led, facilitated, and conducted deviations, nonconformance investigations.
• Identified trends and root causes.
• Identified and wrote investigation action plan as applicable.
• Assisted Subject Matter Experts in writing and conducting investigations.
• Reviewed and verified supporting documents and data for accuracy and completeness.
• Wrote summary investigation reports with root causes as applicable.
• Worked with cross functional areas to determine the root cause/s and corrective and preventive actions.
• Trained personnel as required on conducting investigations and root cause analyses and SOPs.
• Reviewed investigation reports for accuracy and completeness.
• Maintained investigation database and submit monthly reports.
• 1nsured that investigations were completed in a timely manner as required per site SOPs.
• 1nitiated CAPAs, assigned responsibilities, and follow-up for completion.
• Scheduled weekly meetings to assess status of the investigations.
• Communicated/Escalated to management of issues for immediate attention Revise and update SOPs to comply w/ cGMPs and other regulatory requirements.
• Reviewed and approved SOPs, protocols/reports, change controls and investigations.
• Performed Annual Product Review.

Confidential, BOWIE, MD

Quality Consultant

Responsibilities:

• Performed audits of Contract Manufacturing Organizations (CMO) including packaging sites for pharmaceutical products (oral dosage, liquid suspensions) and medical devices.
• Performed gap analysis and remediation in medical device manufacturing and distribution sites in response to FDA 483s and recalls to ensure compliance to 21 CFR Part 210, Part 211, Part 820, Part 801, Part 803, Part 806, ISO 13485, ISO 14971, ISO 19011 and other regulations (European Directives).
• Provided oversight in production of solid dosage and liquid products.
• Revised or assisted with the implementation of SOPs to address process need(s).
• Generated reports to fully address deviations/deficiencies that impact compliant operations.
• Wrote deviations, CAPAs, and OOS reports and led investigations.
• Participated in the review of documents for product release (commercial and clinical).
• Authors and revises Standard Operating Procedures (SOPs) and Quality System documentation.
• Reviewed regulatory documents to support commercial and clinical materials release (e.g. Batch records).
• Identify compliance risk to organization and develop realistic plans to mitigate risks.
• Demonstrated expertise in the principles, practices, methods and techniques of document and records management.
• Performed risk assessment of documents and records.
• Utilized computer and database applications used in records management programs.
• Demonstrated expertise in the use of current document management and storage technologies, including electronic document management system (EDMS).
• Performed Annual Product Review.

Confidential, Norcross, GA

Quality Consultant

Responsibilities:

• Performed audit of manufacturing site and QC laboratories.
• Provided quality support, process design, process improvement and oversight in the manufacturing of medical reagents and devices to meet customers supply demand.
• Shadowed technicians in Red Cell Process Laboratory on the floor to document gaps in Process, SOPs, Procedures, Forms and Attachments.
• Participated in Documentation Improvement Process, SOP Revision Process which included flow charts, visual aids (Pictures, Diagrams or Drawings) and Rewording of parts of SOPs/instructions to remove vague statements.
• Revised and changed the current SOPs procedure section into work instruction, section into Job and forms to capture steps into batch record.
• Served as a mentor and coach on the floor and brainstormed with technicians to improve the process and revise SOPs.
• Provided cGMP/cGLP SME to the process areas of the company that were in non compliance with adhering to ICH Q7A guidelines and 21 CFR 210/ 211/, 820/ part 11 CFR laws. In two months reviewed several SOP’s and shadowed the Red Blood Cell process to capture non conformities. Led non conformity projects/FDA observations/and quality audits.
• Directed team meetings on projects for CAPA / potential compliance issues with consultant teams to set up solid control to produce safe quality products. Reviewed completed batch records and authorized final signature on final batch records.
• Conducted remote QA/QC activities between multiple facilities of Red Blood Cell processes to implement action plans that adhere to Lean and Six Sigma. Monitored and investigated several labs testing techniques for integrity/accuracy.
• Performed Audits, Validation Protocols, FMEA-Root Cause, Document Change Control and GAP analysis.
• Revised / Edited Batch Records to reduce production errors.
• Reviewed Production Batch Records/Laboratory Batch Records/ APR/and DHR.
• Performed technical writing and gave presentations to senior management.
• Investigated customer complaints (VOC).
• Provided DMR/DHR for annual review/ traceability of accuracy.
• Edited SOP’s/Control Documents/Change Control.
• Review Quality Systems/files Medical Device 13485 (Non Sterile) Audits.
• Provided support to ensure the production maintained ISO environment 9000/13485 compliance.

Confidential, BVL BEDFORD, OH

Quality Consultant

Responsibilities:

• Provided full quality support to clients in the form of process design, process improvement, facility design, clean room improvement, batch record review, SOP revision, protocol review, and of technicians, pre-FDA inspection, and audited production areas.
• Performed Manufacturing/Deviation/Non Conformance/ Complaint Investigations and annual product review.
• Supported the ongoing plant readiness, audits and corrective actions.
• Served as a member of quality compliance team as a technical quality resource for the purpose of review of responses to audit findings and implementation of effective solutions.
• Partners with other key departments to review, write and contribute to the development and revision of SOPs, Protocols, Plans and other documents as necessary to address audit findings and 483 warning letters.
• Identified resolutions for sustainable and manageable processes for all phases of manufacturing.
• Generated reports to fully address deviations/deficiencies that impact compliant operations.
• Demonstrated expertise in risk mitigation when addressing Warning Letters, Consent Decrees (CD) and responses to Regulatory authorities.
• Provided Quality Assurance Management in the remediation of regulatory actions (warning letters and consent decrees).
• Provided oversight during the production of lyo and liquid samples, starting from formulation stage, sterile filling and capping of vials.
• Provided oversight in the qualification facilities, equipment and performance qualification of processes (media simulations for sterile products).
• Subject matter expert on resolution of laboratory investigations, manufacturing deviations, CAPAs, aseptic techniques, mentoring & coaching, GMP, cleaning verification method development and validation, equipment IQ/OQ/PQ.
• Performed Annual Product Review.

Confidential, MORRIS PLAINS, NJ

Manufacturing Quality Supervisor

Responsibilities:

• Directed daily commercial manufacturing operations of active cellular immunotherapy drug products through cell processing, from blood drawn from patients suffering from prostate cancer. After completion of cell processing, the drug products were sent back to specific blood donors for infusion for treatment.
• Provided immediate supervision and assigned tasks to a unit or a group of employees to carry manufacturing operations in compliance to FDA, 21 CFR Part 11, Part 210, Part 211, ICH, cGXP, procedures and other regulations.
• Developed SOPs, test reports and out of tolerance notifications.
• Performed Manufacturing/Deviation/Non Conformance/ Complaint Investigations
• Conducted failure analysis, root cause determination and corrective determination.
• Directed or led investigations: deviations, out of tolerance conditions and unexpected results.
• Attended daily and weekly meetings of Deviations and CAPAs.
• Generated quality maintenance reports.
• Represented Facilities in cross -functional teams and projects.
• Performed quality and investigational reviews and audits of raw materials, finished products, packaging components and labeling.
• Ensured employees were compliant with cGMP, Gowning Techniques, Aseptic Techniques, Safety, OSHA, and SOP.
• Provided to operators on aseptic techniques, operator qualification and trainer qualification to perform their functions in sterile manufacturing operations in clean room.
• Selected, developed, and evaluated personnel to ensure functional objectives were met.
• Frequently interacted with direct reports, outside customers and functional peer groups at various management levels. Interaction required ability to gain the cooperation of others, conducting presentations of technical information concerning specific projects / schedules, etc.
• Supported qualification of aseptic processes (media simulation activities), reviewed aseptic media simulation records and generation of final summary reports.
• Performed and generated risk assessments to discuss the approach to aseptic processes related activities.
• Reviewed regulatory documents to support commercial and clinical materials release (e.g. Batch records).
• Participated in internal and FDA inspections of the sterile module environments (clean rooms).
• Participated in Batch Record (BR-45025) and SOP (SOP-10999) revision for Commercial Manufacturing of Provenge in response to FDA observations and commitment.
• Performed Annual Product Review.

Confidential, WEST POINT PA

Senior Manufacturing Supervisor

Responsibilities:

• Directed daily bulk vaccine /solid dosage manufacturing operations.
• Supervised employees engaged in solid dosage/ vaccine production in a clean, scientific work environment which included scheduling and allocating work based on production priorities, critical work checks and performance evaluations, continuous, providing technical guidance, and resolving any problems that arose.
• Ensured every employee met dress and safety codes, competent and qualified for the duties assigned and maintained lab/production areas and equipment at inspection ready status at all times.
• Provided to operators on aseptic techniques, operator qualification and trainer qualification to perform their functions in sterile manufacturing operations in clean room.
• Supervised and assigned tasks to a unit or a group of employees to carry manufacturing operations in compliance to FDA 21 CFR Part 11, Part 210, Part 211, Part 600, Part 601, Part 610, ICH, procedures and other regulations.
• Participated in internal and FDA inspections of the sterile module environments (clean rooms).
• Tracked projects, wrote reports, maintained records, updated SOPs, Process Specific Manuals, and Control Procedures, demonstrated knowledge of cGMP, and administered local agreements, company personnel policies, and OSHA and company safety procedures.
• Wrote deviations, CAPAs, led investigations and sat in departmental committee meetings.
• Performed monthly and yearly internal manufacturing audits for solid and liquid suspensions sites.
• Qualified and audited vendors and suppliers to ensure compliance with quality regulations, standards and metrics.
• Performed product review.

Laboratory Quality Supervisor

Confidential

Responsibilities:

• Supported R&D (Research/Development) laboratories and Quality Unit groups to develop, optimize validation and verification procedures and ensure technology transfers from pilot plant research to commercial were executed in a timely manner.
• Participated in internal and FDA inspections of the laboratory.
• Supervised a group of analysts working in-process monitoring samples, manufactured isolated intermediates, active pharmaceutical ingredients, finished products and technical operations regulatory support projects.
• Wrote deviation, CAPA, and OOS reports and led investigations.
• Coordinated the evaluation, planning, implementation, qualification/validation of new instruments for QC laboratories, and ensured that validated/qualified/calibrated laboratory systems were maintained in a cGMP compliant state throughout their life cycle.
• Reviewed documentation supporting instrument qualification activities and product review.
• Planned and provided Analytical Chemistry support (i.e. method modification and validation, testing, protocol and report writing, and reviewed of regulatory documents) for intermediates and finished products.
• Designed and led formal validation/verification/qualification of analytical test methods starting from protocol generation stage through final reports.
• Supported vendor/supplier relations and negotiated pricing and agreement terms.

Sr. Quality Control Scientist

Confidential

Responsibilities:

• Worked closely with the Research/Development laboratories and Quality Unit groups to ensure that methods development/optimization, validation and verification, and ensuing technology transfer were executed in a timely manner.
• Validated chromatographic methods for assay of pharmaceutical components, drug product containers, and closures.
• Evaluated acquired new analytical technologies: laboratory instruments, computer hardware and department software.
• Calibrated and validated laboratory instruments.
• Supported and performed launching of new products (solid dosage and liquid suspensions).
• Coordinated and performed technical of analytical chemists on analytical instrument techniques such as HPLC, LC/MS, GC, GC/MS, spectroscopy, wet chemistry and physical testing.
• Performed and coordinated analytical method transfer, data review, creation and revision of SOPs as well as routine release, stability testing, and related reports.
• Performed analytical work in support of manufacturing equipment cleaning validation.
• Evaluated OOS investigations and ensured that appropriate corrective actions were followed as stipulated in the FDA and cGMP guidelines and company policy.
• Participated in internal and FDA laboratory inspections and performed product review.

Quality Control Chemist

Confidential

Responsibilities:

• Supported and perfumed analysis in process monitoring samples, manufactured isolated intermediates, finished products and Technical Operations regulatory projects.
• Performed sample preparation, assay and identification of raw materials, recipients, intermediates and finished products by UV-Vis, HPLC, LC/MS, TLC, GC, GC/MS, IR, Tachymetry and Karl Fischer Titrator.
• Participated in pharmaceutical in-process testing, blend homogeneity, dissolution, disintegration, content uniformity, and particle size and friability tests.
• Assisted in general maintenance and calibrated lab equipment.
• Monitored the cleanliness of production machinery and surrounding areas with GMP compliance.

Staff Chemist - Analytical Laboratory

Confidential

Responsibilities:

• Major Functions: Carried out stability programs and performed chemical analysis of drug formulations using both wet and instrumental techniques namely: HPLC, GC, UV, TLC, VK6010DIS, Titrator, Viscometer, KF, PH Meter, Dis.Tester, AA, and FT-IR.
• Tested pharmaceutical products, raw materials, active Pharmaceutical Ingredients and stability samples.
• Performed stability studies on drug products, modified and validated HPLC, LC/MS, GC, and GC/MS, spectroscopic and wet chemical methods in support of the developments of drug formulations.
• Performed qualitative, quantitative, and investigational chemical analyses of raw materials, different drug formulations, finished products, complaint samples, and packaging components.
• Carried out troubleshooting of routine testing methodologies and prepared technical transfer protocols and reports.
• Reviewed and verified analytical test results generated by other chemists. Calibrated laboratory equipment, performed and documented laboratory investigations.