Philadelphia area Quality Manager experienced in supporting Cosmetics, Food, Beverages, Skin Care and Childrens Vitamins manufacturing. He has Bachelors in Chemistry and an MBA. He is versed in several industry software packages including LIMS. He is skilled at performing preventative and operational maintenance on lab instruments including recalibration, part repair\/replace, and chromatography troubleshooting. He is currently employed but they are closing his location. His education, skills, and experience make him a great candidate for you! He is single, renting, and willing to relocate.<\/p>\n\n\n\n
Successfully mitigated the transfer of Self-Care and Over-The-Counter SOPs and Specifications from Johnson and Johnson to Kenvue regulation, ensuring a seamless transition and compliance with regulatory requirements.
\u2022 Worked with over-the-counter drugs, skincare, and children\u2019s vitamins.
\u2022 Demonstrated commitment to quality and compliance by attending scheduled Good Manufacturing Practice (GMP) training, consistently following role-specific procedures, and upholding the highest level of integrity in all tasks performed.
\u2022 Managed R&D teams within stability and Quality Laboratories, as well as documentation specialists in NA, EMEA and
\u2022 LATAM regions.
\u2022 Performed a 90% reduction of over 1,000 unused and obsolete SOPs and Specifications in the Kenvues LIMS system ensuring proper up-to-date documentation.
\u2022 Contract lab operation that supports Food and Beverage clients.
\u2022 Converted and maintained an FDA-suitable Laboratory setting in compliance with 21 CFR as well as cGMP and cGLP guidelines.
\u2022 Supporting companies on production quality for new beverage companies like Swoon and Wake, and Poppi.
\u2022 Performed preventative and operational in-depth maintenance on all HPLC instruments including recalibration, part repair\/replacement, and chromatography troubleshooting saving the company from thousands of dollars\u2019 worth of manufacturer service fees.
\u2022 Can liners were not chemically compatible with formulas and I outsourced new liners that worked.
\u2022 Self-funded the creation and startup of the cosmetic brand ‘Simple Serum LLC’
\u2022 Used insight and experience from pharmaceuticals to properly and safely formulate from scratch emulsion-based serums that are safe, effective, and appealing to consumers.
\u2022 Deals directly with regulatory boards in order to ensure all guidelines are met for sale in each state which includes packaging information, ingredients, and advertisement.
\u2022 Remediate and revise SOPs using Change Controls
\u2022 Worked with Finished Products, Raw materials, and Stability samples.<\/p>\n\n\n\n
\u2022 Food Mfg. Operations – Agtech
\u2022 Cosmetics
\u2022 Pharmaceutical Mfg. Operations
\u2022 Skin Care
\u2022 Children\u2019s Vitamins
\u2022 ISO Standards
\u2022 API Standards
\u2022 ISO 9000, ISO9001
\u2022 ISO 22000 Food Safety Standard
\u2022 Regulatory Boards
\u2022 Hazard Analysis Critical Control Points (HACCP)
\u2022 QMS – Quality Management System
\u2022 21 CFR regulations
\u2022 U.S. Title 21 CFR Part 11 Regulation
\u2022 HPLC Instruments
\u2022 Gas Chromatography
\u2022 Hands-on Quality Lab Experience
\u2022 Working With Lean Teams
\u2022 Change Management
\u2022 Coordinating Lab Activities
\u2022 Calibrating Equipment
\u2022 Using CMM Equipment
\u2022 Portable CMM Machine
\u2022 Managing the Quality Lab
\u2022 Managing Quality Teams
\u2022 Using Quality Database Systems
\u2022 Vendor Offsite Supplier Quality
\u2022 Supplier Validation \/ Qualification
\u2022 Quality Training Experience
\u2022 Production Quality experience
\u2022 Directing Quality Techs
\u2022 Change Management
\u2022 Troubleshooting QC Lab Equipment
\u2022 Technical Writing
\u2022 ISO Auditing
\u2022 Troubleshooting Root Cause
\u2022 Implementing Corrective Actions
\u2022 Implementing Continuous Improvement
\u2022 Optimizing Manufacturing Processes – Agtech
\u2022 Environmental Chamber
\u2022 Tracking Concessions \/ Deviations
\u2022 New Production Line Startup
\u2022 Recommending Specification Revisions
\u2022 Creating SOP Training
\u2022 Process Control Quality Experience
\u2022 Total Quality Management (TQM)
\u2022 Setting Up Quality Systems from Scratch
\u2022 Performing External Quality System Audits
\u2022 FDA
\u2022 cGMP and cGLP Guidelines
\u2022 ISIR Submissions
\u2022 Investigating Customer Complaints
\u2022 Documenting Initial Submissions
\u2022 Using Control Plans
\u2022 Statistical Process Control (SPC)
\u2022 5S \/ 6S
\u2022 Packaging Validation
\u2022 Process Analysis
\u2022 Generating Process Control Charts
\u2022 Process Testing \/ Validation
\u2022 Working with R&D
\u2022 Delivering Cost Reductions<\/p>\n\n\n\n
\u2022 Managerial skills in a Laboratory setting (Quality Control + Microbiology)
\u2022 Extremely fluent with cGMP\/cGLP practices and Compliance across the board
\u2022 Fluent in Six Sigma and ISO 9001 practices and standards
\u2022 Exceptional at writing\/revising\/implementing SOPs, Change Controls, and Methods
\u2022 Experience in authoring, revising, and submitting CAPAs.
\u2022 Experience with FDA and outside contract audits.
\u2022 Thrives with organization, learning, presentation, analysis, problem-solving, conflict resolution, and negotiations.
\u2022 Extensive Project Management experience from an overseer level to a management level.
\u2022 Excels at performing external and internal audits on CMC environments and documentation.<\/p>\n\n\n\n
EDUCATION<\/strong> COMPUTER PROGRAM FLUENCY<\/strong> Philadelphia area Quality Manager experienced in supporting Cosmetics, Food, Beverages, Skin Care and Childrens Vitamins manufacturing. He has Bachelors in Chemistry and an MBA. He is versed in several industry software packages including LIMS. He is skilled at performing preventative and operational maintenance on lab instruments including recalibration, part repair\/replace, and chromatography troubleshooting. He is…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[311],"tags":[28,82,361,488,931,932,933,934,935,936,937],"class_list":["post-2681","post","type-post","status-publish","format-standard","hentry","category-production-operations-quality","tag-manufacturing","tag-mba","tag-quality-manager","tag-food","tag-bschem","tag-cosmetics","tag-beverages","tag-skincare","tag-childrens-vitamins","tag-lims","tag-pharmaceuticals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/posts\/2681","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/comments?post=2681"}],"version-history":[{"count":2,"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/posts\/2681\/revisions"}],"predecessor-version":[{"id":2683,"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/posts\/2681\/revisions\/2683"}],"wp:attachment":[{"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/media?parent=2681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/categories?post=2681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mriomega.com\/index.php\/wp-json\/wp\/v2\/tags?post=2681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\u2022 Masters of Business Administration (MBA) \/ Thomas Jefferson University Philadelphia, Pa August 2022 – May 2024
\u2022 Bachelor of Chemistry \u2013 Rutgers Chemistry Department Rutgers University New Brunswick, NJ September 2015 – May 2019<\/p>\n\n\n\n
\u2022 Empower- Used for processing and organizing runs from HPLC\/GC methods.
\u2022 Microsoft Excel- Adequate in organizing and understanding experimental data. Proficient at using excel to carry out difficult analytical equations that would otherwise take time to carry out by hand.
\u2022 Origin Pro- Fluent in using Origin Pro to analyze spectrochemical data, along with analyzing peak heights and areas under curves.
\u2022 LIMS- Used to enter and organize physical and analytical data prior to testing samples and drugs.
\u2022 Lab Solutions: Fluent in processing HPLC, GC and LC run through Lab solutions. Can troubleshoot and manage.
\u2022 CorelDraw – Adept at graphic design for logos, packaging, regulatory information and branding
\u2022 Fusion – LIMS technology used to track stability studies, stability chamber management, quality testing results, and product release.
\u2022 CEDMS – Tool used to route company explicit documents for signatures and verification.<\/p>\n","protected":false},"excerpt":{"rendered":"