Accomplished ** plus years of progressive experience and proven record of significant, successful contribution in quality control, project management, process improvement, business analysis/evaluation, New product-development life cycle methodologies, supplier management, and quality management processes. Strong command in HPLC operation and troubleshooting, method development and method validation. Ability to work in multinational matrix organization with cross-departmental goals. Highly experienced, goal oriented, team player, organized and result driven professional with diverse experiences in Quality Control.

Quality Assurance Management/SOP

Supplier Management

Continuous Improvement

Proficient in Computerized HPLC, UPLC

Proficient in computerized GC, UV-vis, IR, AA, TOC

Proficient in Wet Chemistry Testing

Proficient in various HPLC software programs such as Galaxie Vol. 1.7 Water Millenium, HP Chem Station, Varian Stars, Shimadzu

Auditing (Process/Product)

CAPA/OOS Investigations

Organizational Training

Organizational Change Management

ISO 9001-2000 Certification Management

FDA 111, 117, 210/211, 113/114

EU Regulations

Change Controls Cleaning Validations

Data Analysis/tracking/Trending

Project Management

Total Quality Management

Cross functional leadership

Strong Verbal/Written Communication

Process Implementation

Product Testing

Extremely Organized

Methodology Implementation

Risk Management

Staff Development

Strategy Development

Contract Pharmacal Corporation

Director, Quality Control March 2006- September 2022

Oversees overall operations and administration of Quality Control Laboratory

Ensures efficient operations of the Quality Control and Microbiological Laboratories

Involved in writing SOP and Test Methods

Provide technical expertise for laboratory investigation and reports in response to OOS, invalid assays, aberrant trends/results, and manufacturing investigation

Implement and maintain Quality and Compliance Systems for QC personnel in accordance with current cGMP and regulatory requirements.

Ensure daily tasks are planned for day and night shift are performed and reported efficiently and are within compliance

Responsible for all QC activities, focusing on areas related to batch review and product releasing to assure timely supply of product

Developed SOPs for quality testing of materials.

Developed a QA system for the company Trained & supervised laboratory personnel on lab procedures

Conducted Inventory of the lab supplies and managed orders. Developed inventory database for the company

Carryout Statistical analysis and interpretation of lab data

Qualified suppliers against 21 CFR 210/211 regulations.

Manage all related contracts on all QC equipment

Identified and assisted with implementation of cost savings opportunities for purchased of new laboratory equipment.

Assisted in the planning, design, procurement of new equipment or physical systems where required, from a validation or industry compliance perspective. (IQ, OQ and PQ)

Active team member on the Innovation/New product launch/Stage Gate organization, representing quality control on all aspects

Orchestrated activities between cross functional groups (Regulatory, Product Development, Analytical services, Commercial, Procurement, Labeling, QA) to ensure flawless execution of new product launches

Monitored, analyzed, and redesigned workflow, processes, and procedures to resolve budget expenditures using root cause analysis.

Served as main escort for FDA and 3rd party auditors

Provide FDA regulatory guidance to the VP, and peer executive leadership; Confer when necessary, with outside consultants. Explain new legislation and regulations to senior management and affected employees

Part of cross functional team in setting up a new lab for the company

Actively identified projects across all external operations to implement continuous improvement projects.

Coordinated continued compliance with FDA regulations. Ensured the company’s QA system was effective, efficient, and compliant to applicable FDA and other government regulations and customer requirements for contract manufacturing of finished products. Ensured compliance with national and international standards and regulations.

Managed timely resolution of customer issues and complaints to increase customer satisfaction by use of effective root-cause analysis to identify and eliminate the sources of customer dissatisfaction

Created and revised raw material and finished product testing specifications for global use in the QC laboratories

Coordinated third party testing requirements

Developed staff through feedback, coaching, counseling, and support

Actively involved in hiring new personnel for the laboratory

Altaire Pharmaceutical

Senior Chemist January 2001 – October 2006

Wrote protocols for cleaning validation, performed test of protocols and established parameters based on testing

Performed testing on validation and verification protocols utilizing HPLC, UPLC or ICP as stipulated in protocol

Performed testing on In-process blend, core, finished product and stability samples utilizing in-house and/or USP methods

Strictly adhered to all applicable safety and standards guidelines, such as SOP, cGMP and SDS

Assist in planning internal quality, customer, or regulatory audits.

Conducted Inventory of the lab supplies and managed orders. Developed inventory database for the company

Carry out internal calibration of laboratory equipment

Train newly employed personnel

Danisco Cultor, Hauppauge 11788

Analytical Chemist June 1990 – December 2000

Test raw materials, core and finished products utilizing In-house and/or USP methods

Perform testing on product utilizing High Performance Liquid Chromatography (HPLC)

Perform particle size analysis utilizing Sirocco Mastersizer 2000 optical unit and manual set of sieves

Perform and analyze TOC testing using GE Water and Process Technologies Analytical Instrument Sievers 900

Proficient in the use of various instruments which includes GLC, UV, IR and Wet Analysis using AOAC method on raw materials and Finished Flavors

Perform test on minerals using Inductively Coupled Plasma Optical Emission Spectrometer (ICP) Monitored, maintained, and reviewed data of humidity and temperature of loggers for all facilities

Responsible for data entry of New York formulars into company’s operating system when received from R&D.

Ensure timely completion of all customer complaints

Strictly follow all applicable safety and standards guidelines, such as SOP, cGMP, and SDS

Conducted Inventory of the lab supplies and managed orders. Developed inventory database for the company

Felton Worldwide, Brooklyn NY 11237

Analytical Chemist January 1987 – December 1986

Proficient in the use of various instruments which includes GLC, MS, HPLC, UV, IR, AA and Wet Analysis using AOAC method on raw materials, Flavors and Fragrance

Trained as Junior Organoleptic Evaluator

Responsible for training New Hires

Strictly follow all applicable safety and standards guidelines, such as SOP, cGMP, and SDS

Conducted Inventory of the lab supplies and managed orders. Developed inventory database for the company

Stony Brook University, Stony Brook, NY

Bachelor of Science in Chemistry 1985-1990

GPA 3.8

Furnish upon request

EXECUTIVE SUMMARY

CORE COMPETENCIES

PROFESSIONAL EXPERIENCE

EDUCATION

Reference

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