Highly motivated quality professional with experience in the Dietary Supplement/Sports Nutrition/Pharmaceutical and Consumer Goods industries. Excellent reputation for project management, resolving problems, improving workflow processes, and driving overall quality standards and improvements. Experience in policy development, SOP writing and staff management. GMP
Process and Procedure implementation
Supplier Qualification Manager, 04/2016 to 04/2019 International Vitamin Corporation – Freehold, NJ
Developed, implemented and managed the Supplier Qualification Department for the Company's five U.S. manufacturing facilities as well as contract manufacturers focusing audit and material documentation review.
Managed three direct reports.
Implemented and managed sustainability programs including on site evaluations, internal audits and customer surveys at all locations for Roundtable of Sustainable Palm Oil (RSPO), Marine Stewardship Council (MSC), and Non-GMO Project Verified (NGPV). Created and maintained a company wide informational data base on over 1900 raw materials and 600 supplier manufacturing sites.
Developed and maintained a data base for organic, kosher, halal and Non-GMO product certification requirements to provide support to all facilities. Participated in on-site 3rd part audits with Regulatory bodies and external customer. Met with suppliers to provide overview of supplier qualification process and/or new customer initiatives. Daily interaction with Global Sourcing and Procurement for supplier approval and PO risk release. Analyzed and complied data to complete various surveys. Liaison between QC and suppliers as needed for documentation issues. Communicated regularly with auditing firms and suppliers locally and internationally on issues and documentation requests, customer inquires/requests. P S
Worked directly with R&D and PD on new raw materials and suppliers ensuring the materials and facilities met with customer and company regulatory standards and requirements. Participated in NDA reviews with internal legal department pertaining to supplier provided confidential information.
Completed retailers questionnaires and provided regulatory statements as requested. Provided support to the technical group and call center for customer product inquiries and complaints. Regulatory Affairs Supervisor, 09/2010 to 04/2016
International Vitamin Corporation – Freehold, NJ
Oversaw the manual approval process of raw materials and factory approvals between involved departments.
Managed two direct reports.
Organized and updated supplier documentation to meet all current laws and regulations. Wrote and updated SOP's within the quality group.
Provided requested regulatory documentation internally as requested. Verified approved materials and manufacturers with Procurement and R&D as requested. Reviewed label masters for ingredients and allergen accuracy. Contributed to FDA, UL, USP third party audits as well as various other auditing firms. QC / QA Manager, 01/2009 to 01/2010
Jodhpuri, Inc – Parsippany, NJ
Oversaw the production of products in house as well as overseas and ensured they met all quality standards as well as all state regulations.
Work daily with our testing labs and suppliers and maintain all paperwork related to these areas such as testing reports, COC's, COA's and SDS sheets.
Inspect all incoming raw material and finished product and maintained records. Directed internal personal as well as overseas factory on product labeling, making sure we comply with FPLA standards and requirements.
Proofread all artwork.
Requested all factory audits and inspection.
Review final reports and provide recommendations.
Initiated, set-up and maintain our chemical response hotline. Handle all compliance related customer requirements. Respond to all consumer questions and complaints.
Compliance / QC Supervisor, 01/2003 to 01/2008
Alco Consumer Products Inc – Cranbury, NJ
Key player in forming a new Compliance Department, saving the company over $1 million in 2004 by creating SOP's and reducing customer chargebacks.
Directed a compliance committee to review customer compliance and routing guides. Created internal product testing protocols for 6 product categories. Researched State and Federal requirements pertaining to new product categories. Enforced Social Compliance procedures with overseas factories for such customers as Costco, CVS, Wal-Mart, Walgreens, Sears, QVC, Toys R Us / Babies R Us. Coordinate and track overseas audits, inspections and testing with third party inspectors. Implemented Corrective Action Plans for issues uncovered during factory audits and product testing. Updated and maintained 25+ customer routing and compliance guides, ensuring all customer specific requirements were communicated to multiple departments and followed. Reviewed product designs and samples to eliminate product safety issues prior to manufacture. Communicated and implemented necessary changes to conform to updates in customer and governmental product safety requirements.
Participated in customer meetings regarding compliance and quality issues. Directed internal departments as well as factories on customer retail labels, as well as all product instructions and safety warnings.
Coordinated product testing with domestic and international testing labs (CTL, BV, Intertek). Associate of Applied Business: General Management Focus, Expected in 01/2021 Eastern Gateway Community College
DS-21 CFR 111 Dietary Suppliment GMP Training
Vendor Qualification And Audit Training Course
Nafta Rules And Tariff Classification Training
Global Training Center
Certification: Economics And Business Law
Katherine Gibbs - New Jersey