Quality Manager (241126) BSChem, MBA / Cosmetics, Pharma, Food, Beverages, SkinCare, Vitamins Mfg. / Will relo
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.
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.
• Worked with over-the-counter drugs, skincare, and children’s vitamins.
• 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.
• Managed R&D teams within stability and Quality Laboratories, as well as documentation specialists in NA, EMEA and
• LATAM regions.
• 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.
• Contract lab operation that supports Food and Beverage clients.
• Converted and maintained an FDA-suitable Laboratory setting in compliance with 21 CFR as well as cGMP and cGLP guidelines.
• Supporting companies on production quality for new beverage companies like Swoon and Wake, and Poppi.
• 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’ worth of manufacturer service fees.
• Can liners were not chemically compatible with formulas and I outsourced new liners that worked.
• Self-funded the creation and startup of the cosmetic brand ‘Simple Serum LLC’
• Used insight and experience from pharmaceuticals to properly and safely formulate from scratch emulsion-based serums that are safe, effective, and appealing to consumers.
• 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.
• Remediate and revise SOPs using Change Controls
• Worked with Finished Products, Raw materials, and Stability samples.
• Food Mfg. Operations – Agtech
• Cosmetics
• Pharmaceutical Mfg. Operations
• Skin Care
• Children’s Vitamins
• ISO Standards
• API Standards
• ISO 9000, ISO9001
• ISO 22000 Food Safety Standard
• Regulatory Boards
• Hazard Analysis Critical Control Points (HACCP)
• QMS – Quality Management System
• 21 CFR regulations
• U.S. Title 21 CFR Part 11 Regulation
• HPLC Instruments
• Gas Chromatography
• Hands-on Quality Lab Experience
• Working With Lean Teams
• Change Management
• Coordinating Lab Activities
• Calibrating Equipment
• Using CMM Equipment
• Portable CMM Machine
• Managing the Quality Lab
• Managing Quality Teams
• Using Quality Database Systems
• Vendor Offsite Supplier Quality
• Supplier Validation / Qualification
• Quality Training Experience
• Production Quality experience
• Directing Quality Techs
• Change Management
• Troubleshooting QC Lab Equipment
• Technical Writing
• ISO Auditing
• Troubleshooting Root Cause
• Implementing Corrective Actions
• Implementing Continuous Improvement
• Optimizing Manufacturing Processes – Agtech
• Environmental Chamber
• Tracking Concessions / Deviations
• New Production Line Startup
• Recommending Specification Revisions
• Creating SOP Training
• Process Control Quality Experience
• Total Quality Management (TQM)
• Setting Up Quality Systems from Scratch
• Performing External Quality System Audits
• FDA
• cGMP and cGLP Guidelines
• ISIR Submissions
• Investigating Customer Complaints
• Documenting Initial Submissions
• Using Control Plans
• Statistical Process Control (SPC)
• 5S / 6S
• Packaging Validation
• Process Analysis
• Generating Process Control Charts
• Process Testing / Validation
• Working with R&D
• Delivering Cost Reductions
• Managerial skills in a Laboratory setting (Quality Control + Microbiology)
• Extremely fluent with cGMP/cGLP practices and Compliance across the board
• Fluent in Six Sigma and ISO 9001 practices and standards
• Exceptional at writing/revising/implementing SOPs, Change Controls, and Methods
• Experience in authoring, revising, and submitting CAPAs.
• Experience with FDA and outside contract audits.
• Thrives with organization, learning, presentation, analysis, problem-solving, conflict resolution, and negotiations.
• Extensive Project Management experience from an overseer level to a management level.
• Excels at performing external and internal audits on CMC environments and documentation.
EDUCATION
• Masters of Business Administration (MBA) / Thomas Jefferson University Philadelphia, Pa August 2022 – May 2024
• Bachelor of Chemistry – Rutgers Chemistry Department Rutgers University New Brunswick, NJ September 2015 – May 2019
COMPUTER PROGRAM FLUENCY
• Empower- Used for processing and organizing runs from HPLC/GC methods.
• 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.
• Origin Pro- Fluent in using Origin Pro to analyze spectrochemical data, along with analyzing peak heights and areas under curves.
• LIMS- Used to enter and organize physical and analytical data prior to testing samples and drugs.
• Lab Solutions: Fluent in processing HPLC, GC and LC run through Lab solutions. Can troubleshoot and manage.
• CorelDraw – Adept at graphic design for logos, packaging, regulatory information and branding
• Fusion – LIMS technology used to track stability studies, stability chamber management, quality testing results, and product release.
• CEDMS – Tool used to route company explicit documents for signatures and verification.