Quality Assurance Control

SHAWN HAWKINS

Boston, MA ********@*****.*** www.linkedin.com/in/shawn-hawkins-650a0179/

SUMMARY

Knowledgeable and experienced Quality Assurance professional with a background in pharmaceutical/medical devices with proficiency in quality management systems, good manufacturing/documentation practices and industry standards.

CORE COMPETENCIES

•Quality Metrics Reporting

•Product Disposition

•Label and Packaging

•Batch Record Reviews

•Records Management

•Training

•Non-Conformance Program

•MS Office

•Customer Service

•LEAN Objectives

•SAP

•Shipping/Receiving/Inventory

•GMP/GDP

•ERP

•Quality COntrol

WORK EXPERIENCE

MassBiologics, Boston, MA

October 2022- Present

QC Analyst II

•Inspection, sampling, testing, labeling and release of raw materials and SU components for cGMP. manufacturing use.

•Review raw data and results from contract laboratories for raw materials testing.

•Troubleshooting of inspection and sampling atypical results and perform OOS investigations as required.

•GMP documentation; SOP's and material specifications generation, revision, and approval.

•Active member of cross-functional teams with Supply Chain, Quality Assurance, Manufacturing, Bioprocess, and external.

•Creating RM’s and Spec reports

•CMO/CTOs.

•Knowledgeable about material qualification and raw material risk assessment.

•Dealing with customer compliments

•Setup of computer hardware and infrustrature

•Placing orders and dealing with all types of vendors

Seres Therapeutics (contract) Cambridge, MA

Feb 2022-August 2022

QC Raw Materials Associate

•Inspection, sampling, testing, labeling and release of raw materials and SU components for cGMP. manufacturing use.

•Review raw data and results from contract laboratories for raw materials testing.

•Troubleshooting of inspection and sampling atypical results and perform OOS investigations as required.

•GMP documentation; SOP's and material specifications generation, revision, and approval.

•Active member of cross-functional teams with Supply Chain, Quality Assurance, Manufacturing, Bioprocess, and external.

•CMO/CTOs.

•Knowledgeable about material qualification and raw material risk assessment.

Sanofi Corporation (contract) Framingham, MA

May 2021- Feb2022

Manufacturing Associate II

•Practice and promote safe work habits while performing operations in Large Scale Cell Culture(manufacturing).

•Under general guidance and accordance with manufacturing instruction and following current GMPs.

•Maintain cleanliness and orderliness of manufacturing process areas.

•Ensures production materials which are required in the manufacturing suite are fully stocked.

•Performing batch records and SOP's reviews procedures.

•Interacting and supporting the following departments: Quality Assurance, Quality Control, Manufacturing, Engineering, MSAT, Validation, etc.

•Role of a lead trainer and SME on numerous operations.

•Ability to demonstrate troubleshooting basic mechanical operations.

•utilizing manufacturing Knowledge to improve process operations and positive changes.

•Following verbal and written procedures in operating production equipment and performing.

Seluxdx Diagnostics (contract), Boston, MA

June 2020 - April 2021

Warehouse Associate/Quality Control

•Pack and ship material corresponding to the proper shipping vendors including but not limited to: UPS, FedEx.

•Label and package material in accordance to quality inspection.

•Assist with customer service related to vendor management.

•Inventorying and transferring of materials.

•Organizing and setting meetings.

•Preparing materials for upcoming and outgoing shipments.

•Handle Hazmat Materials.

AD Biotech Solutions, Boston, MA MAY 2018 - SEPTEMBER 2019

Warehouse Associate

•Maintain inventory of warehouse components, chemicals and incoming raw materials.

•Receive, process and segregate hazmat materials.

•Label and package material in accordance to quality inspection.

•Train new employee with ERP database and warehouse receiving and allocating duties,

•Perform and assist with 5S projects as assigned by management.

•ERP database use for all inventorying and allocation processes.

•Hand scanners used in conjunction with ERP database for proper allocation, inventorying and transferring of materials.

•Pack and ship material corresponding to the proper shipping vendors including but not limited to: UPS, FedEx, DHL.

•Use powered and manual hand trucks for receiving and shipping.

•Assist with customer service related to vendor management.

Integra Lifesciences, Boston, MA SEP 2016 - MAY 2018

Quality Assurance Associate

•Tracked and maintained quality metrics to support quality management systems for continuous improvement and LEAN activities.

•Conducted monthly inspections to support facilities maintenance of all equipment and areas within clean rooms.

•Generated shipping certificates (i.e. partner, EDQM, and local site) for appropriate release of product.

•Reduced turnaround time for batch record and device history record (DHR) reviews for finished goods release.

•Accurately performed good hexagon expiry dates determinations and creation of bar codes for finished good lots.

•Reviewed and approved raw and intermediate material to support Manufacturing and Quality Control .

•Participated in quarantining non-conforming material to ensure proper segregation.

•Reviewed, archived, and maintained all site quality records in accordance with the retention policy.

Genzyme Corporation, Northborough, MA FEB 2006 - SEP 2016

Quality Control Analyst

•Quarantined and dispositioned incoming raw materials to ensure materials are compliant and meet MS specifications.

•Ensured equipment used for sampling and testing is compliant and usable as a Metrology Liaison.

•Trained, worked and transferred chemicals in ISO9001 cleanroom and conducted monthly. inspections to support facilities maintenance of all equipment and areas within clean rooms.

•Rejected and disposed expired and obsolete materials.

•Tracked and provided monthly report of inventoried materials stored in Quarantine, 2-8 C, -20 C, Rejected and QC hold areas.

•Proficient in use of Microsoft Office Suite, Live Link, Plateau, File Maker, MFG Pro, Starlims and Athena SAP.

•Operated Raymond industrial forklift truck model 750R45TT and Raymond RAS25 forklift.

•Complied with 21CFR federal regulations.

Genzyme Corporation, Allston, MA Oct 1999 - Feb 2006

Senior Manufacturing Technician, Fill/Finish and Packaging

•Capped and inspected lyophilized products in glass vials.

•Labeled and packed the finished goods.

•Trained new employees on all procedures and equipment used in the Fill/Finish Packaging Department.

•Conducted training presentation on the Sancoa Labeler and Technician Cartoner.

•Managed materials and supply inventory.

•Maintained eye wash stations to ensure operational and safety standards complied.

EDUCATION

HAZMAT GROUND SHIPPER NOTIFICATION BOSTON, MA

•Certified 07/11/2018

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