ROY W FOSTER

CAREER SUMMARY

●** years of experience in Quality Control Management for food /beverage, pharmaceutical, manufacturing, packaging and distribution facilities

●10 years of experience ensuring GCP and GVP guidelines are met in Clinical, R&D and pharma environment

●5 years of experience as Quality Assurance Manager

●Validation of Systems, Vessels, processes, CSV, API Application Program Interface

●8 years leading and responding to Facility Audits. ( ISO, AIB, FDA, FSMA and SQF)

●Developed/ maintained GMP, SOP and HACCP, recall and mock recall, allergen, and food security programs.

●Performed Food Safety and GMP and Quality systems Audits of Suppliers and company processing plants.

●Managed Quality department of up to 27 direct employees.

EDUCATION

Grambling State University, Grambling, Louisiana

BS, Biology May 2003

CERTIFICATIONS

ASQ, FSMA, Six Sigma Green belt, OSHA certified, FDA, SQF (Safe Quality Foods Practitioner Level 2 and 3), TQM, HACCP certified

Work History

Bristol Meyers Squibb, Artech

QA Deviation Reviewer (Contractor) Oct 2021 - Present

●Providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility

●Ensuring accurate and timely maintenance and review of procedures and methods

●Providing compliance oversight for Manufacturing Operations and QC laboratories

●Ensure accurate and timely review of manufacturing and laboratory investigations

AstraZeneca

Quality Engineer (Contractor) Feb 2021- July 2021

●RCA’s and Review and approval of Lab investigations

●Complaint management

●Documents review and approval

Ecolab Sept 2020- Feb 2021

Quality Systems Manager (Contractor)

●Prepared plant for SQF certification

●Ensured GVP guidelines were met for pharma products

●Managed and created SOP’s to align with applicable SQF code

●Coached and trained personnel to comply with new policies and procedures

●Collaborated with Area managers to complete transition Food Safety compliance

Watts Water July 2019 – April 2020

Quality Engineer

●Implemented RCCA methodologies at the management level

●Prepared Quality Organization for site relocation

●Handled OOS product and incoming parts from suppliers

Johnson and Johnson Feb 2018 - May 2018

QA Manager, CAPA Specialist (Contractor)

●Remediation of Non-conformances, CAPA’s,

●Ensure GMP, GCP,and GVP, were met for facility

●Audit Findings and change controls

●Ensured medical devices and pharmaceutical products were stored and shipped per CFR 21

●Created and reported metrics to senior management for multi-site performance vs standard

Aloe Vera of America July 2017 -Jan 2018

QA Manager, Validation Specialist (Contractor)

● Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

●Analyzes the results of IQ, OQ, and PQ testing and determines the acceptability of results against predetermined criteria.

●Ensure GMP, GCP,and GVP, were met for facility

●Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

●Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

Impact Fulfillment Services Dec 2015 – 2017

Site Quality Manager

●Manage the site Quality Assurance department, consisting of 25+ employees, including 4 QA Supervisors and two levels of Associates.

●Ensure the IFS SOPs are up to date / being followed.

●Ensure Major process and equipment validation by overseeing IQ, OQ, and PQ testing Results.

●Lead the site’s SIP program and process improvement efforts.

●Ensure GMP, GCP,and GVP, were met for facility

●Manage the corrective action process to ensure that non-conformances are resolved with appropriate and effective actions taken.

AB Mauri North America (Baking Ingredients) Feb 2014 – Dec 2015

Quality Control Manager

●Regulatory Compliance/Quality Assurance - Meet or exceed all applicable government and company food safety standards. Achieved SQF audit score of 98%.

●Plan and execute plant-wide quality engagement activities to promote quality agenda.

●Ensure GMP, GCP,and GVP, were met for facility for product research

●Design, implement, maintain and oversee quality management systems that ensure all products meet or exceed company quality specifications; ensure that all exceptions to product quality standards are promptly and thoroughly investigated, and root causes are identified and corrected; ensure all customer qualification requirements are met or exceeded; and ensure full compliance with SQF 2000 level 2 quality standards.

●Perform duties of the SQF Practitioner. Fully and promptly investigate customer complaints, prepare timely written responses in accordance with Corporate QA Policy, and develop and implement effective measures to prevent recurrence.

●Meet or exceed all customer and third party requirements for food safety standards, administer and ensure execution of HACCP programs and prerequisite programs, and ensure food safety and security.

●Monitor and report on required customer qualifications, assist with environmental and regulatory compliance, and communicate potential recall/withdrawal situations to Corporate QA.

●Coordinate New product launches and reformulations by completing validation processes.

Novartis Alcon Labs Corporate June 2013 – Dec 2013

Global Quality Management Systems (contractor)

●Corporate standard and process implementation verification for 48 sites worldwide

●Provide support for creation, implementation and maintenance of global SOPs related to quality systems, in alignment with the corporate standards.

Miller Coors 2004-2012

Quality Control Supervisor / Product lab chemist Fort Worth, TX

●Manage, examine and initiate actions against consumer complaints, gap analysis, and process improvement plans.

●Provide quality support to 9 Team Leaders and 90 Line Operators by facilitating annual quality certifications, job training, crisis management, disposition of held product, and process improvement.

●Direct personnel actions including, spearheading the transition of employees from Quality Control activities to Quality Assurance systems

●Conduct internal audits according to HACCP and SQF standards

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