Linda Y. Smith

203-***-****

adw8tj@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Bilingual, English and Spanish fluent proficiency in both.

Frequent interaction and communication with clients

Consistently able to use independent judgment and manage confidential information

Strategic-relationship/partnership-building skills; listen attentively, solve problems creatively, use tact and diplomacy to find common ground and achieve desired end goals

Strong ability to gather data, compile information and prepare various reports

Unwavering commitment to customer service, with the ability to build productive relationships, resolve complex issues and win customer loyalty

Exceptional ability to prioritize work to meet goals and objectives within specific time frames PROFESSIONAL EXPERIENCE

Regulatory and Quality Assurance Specialist-CellMark Ingredients., Naugatuck, CT (2018-2022)

• Ensure compliance with FDA Food Safety Modernization Act (FSMA) regulations: 21 CFR PART 117

(Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls for Human Food)

• 21 CFR PART 1 Subpart L

(Foreign Supplier Qualification Program)

• 21 CFR PART 121

(Mitigation Strategies to Protect Food Against Intentional Adulteration)

• Oversee and maintain the Food Safety, Foreign Supplier Qualification, Food Defense plans and Environmental Monitoring program.

QUALITY RESPONSIBILITIES

• Direct standard operating procedures for all stages in manufacturing

• Initiate, write, approve, and implement procedures and revisions

• Establish/ review and approve master manufacturing records and revisions Documentation

• Assure that current versions are employed

• Take corrective actions when necessary

• Supervise record retention

• Establish change control procedures

• Oversee pest control, temperature/humidity, and microbial water testing records

• Supplier qualification: Direct new manufacturer and new product qualification reviews

• Compose new manufacturer notification letters to be forwarded to customers

• Maintain new manufacturer documentation

• Complaints & Returns Handling

• Investigate complaints and prepare comprehensive responses

• Initiate and forward to customer, Return Authorization

• Upon receipt of returned product coordinate with Quality Control, receipt of materials and testing

• Document results and disposition of returned product

• Correspond with customers regarding quality issues with raw materials and finished goods

• Track and document quality complaints

• Approve and implement Corrective and Preventative Actions (CAPA)

• Issue and oversee product recalls

• Raw material quality complaints

• Correspond with manufacturers regarding issues with raw materials

• Track and document quality issues

• Point of contact for FDA, State of Connecticut, KOSHER, and customer audits.

• Prepare official responses to customer audits and 3rd party audits

• Maintain Non-Disclosure Agreements

• Perform Internal audits to assess compliance to FSMA regulations

• Assure best practices are being implemented and followed for FSSC 22000 recertification

• Manufacturing Batch Records

• Manage and direct product releases

• After production is completed, review batch record for proper documentation

• Compose Certificate of analysis upon receipt of test results

• Review lab reports, initial/ date/ attach to batch record

• Outside laboratories communication: Obtain information from labs regarding test methods, costs, and status of reports

• Investigate out of specification results for manufactured products

• General understanding of GHS compliance; SDS for raw materials and CellMark manufactured products. Sales Support/Coordinator CellMark, Inc., Norwalk, CT (2012-2018)

• Manage a high-volume workload within a deadline-driven environment for one of the world’s foremost providers of supply chain services to the pulp and paper industry – generating over $3.0 billion in annual sales

• Participate in weekly sales calls for existing clients and quarterly group meetings

• Provide various client service functions for a large client base, using various client-specific interfaces

• Monitor customer credit standing and supplier payments and process and approve supplier invoices

• Provide on-going support to sales force with new business ventures and cost/sales analysis

• Knowledge of relevant commodities, prices, customers, suppliers and competitors

• Collect, enter, organize and track data inputs

• Participate in weekly production meetings with department and senior management

• Handle quality claims for customers and address them with the Flambeau River Papers United States Army Reserve Fort Leonard Wood, MO & Fort Jackson, SC October 1995 - 2002

• Served five years active duty and two years inactive duty

• Reported to the 439th Quarter Master- Petroleum Unit

• Heavy Weight Construction Equipment Mechanic servicing scrapers, dozers, hummers and 5-ton utility trucks and changed tracks on Boxer Tracked Armored Vehicles.

• Honorably discharged in 2002

Education

Housatonic Community College – Bridgeport, CT 2001 Associates Degree – Business

SKILLS

Proficient in Spanish Language, Microsoft Office, Crystal Reports, Citrix IFS systems, Go-To Meeting

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