Senior Manufacturing & Compliance Specialist

Katreen Asaad

E-mail:***********@*****.***

Cell: 508-***-****

HIGHLIGHTS AND QUALIFICATIONS

Qualified in Medical Device cGMP Packaging & Labeling Operations

Experience with SAP (Athena) Transactions and system management

Proficient in Veeva system (QMS) for document control and management

Experience with the Arpeges system (Statistical software) and retention codes

Knowledge in Continuous Improvement Methodologies (GPS3, 6 Sigma, LEAN)

Knowledge in Deviation, CAPA, and Effectiveness Check processes

Assisted with internal/external audit activities, including document review, data verification, and compliance checks.

Author, Create, Edit, Obsolete SOPs, Product and Raw Material Specifications

PROFESSIONAL EXPERIENCE

Manufacturing Associate

Sanofi, Framingham, MA 04/2023 – Present

Train personnel and perform diverse manufacturing tasks in labeling and packaging production areas

Managed raw material procurement lifecycle by initiating material requests, coordinating with supply chain, and receiving/verifying incoming materials to ensure uninterrupted production flow and inventory accuracy

Collaborate with supporting groups to ensure adequate inventory of printed and non-printed packaging materials

Execute work order entries and resolve material issues utilizing SAP systems

Participate in investigations and author/update technical documentation

Administer process activities, ensuring technical readiness, documentation accuracy, and adherence to cGMP and corporate governance

Review and approve documents in the Veeva system to ensure regulatory compliance.

Update and extend BOMs and recipes in the SAP system

Ensure staff maintains appropriate knowledge of department processes and procedures

Accountable for manufacturing project completions and achievement of compliance goals

Collaborate with maintenance team using EAM system to prioritize and resolve equipment issues efficiently

Senior Manufacturing Technician

Sanofi, Framingham, MA 03/2022 – 04/2023

Performed SAP (ATHENA) transfer orders and process order cockpit operations(ZP61N)

Created Transfer Orders and received Stock Transfer Orders from the Sanofi Northborough facility

Managed batch record requests and reviewed batch records for Seprafilm, HA-CMC, and logbooks

Coordinated label shop orders and raw material requests

Manufacturing Technician

Sanofi, Framingham, MA 07/2020 – 03/2022

Executed labeling and packaging processes for Seprafilm products

Performed equipment setup and reconciliation according to SOPs

Collaborated with associates and technicians to complete daily manufacturing responsibilities

Maintained compliance with cGMP standards and quality requirements

Calculate, record/enter critical cGMP data in product batch records, logbooks, and documentation.

Operations Manager

DWS INC-01/2017-09/23

Reduced operating budget by $45,000 annually by developing a new inventory management process

Planned daily operational strategies, including delivery routing, team workflows, and promotional initiatives

Managed full-cycle accounts payable processes, including invoice verification, payment processing, and vendor reconciliation to ensure accurate and timely financial transactions

Administered employee payroll operations utilizing Paychex Flex system, including employee enrollment, role assignments, and payroll processing to ensure accurate and compliant compensation

Collaborated with staff to maximize customer satisfaction, streamline procedures, and improve profitability

Reviewed daily financial reports and reconciled accounts to maintain current and accurate information

Organized budget documentation and tracked expenses to maintain business control

Accounting Assistant

Sheraton Hotel &Conference Center - Framingham, MA 09/2014 – 03/2020

Reconciled company accounts, including credit cards, employee expenses, and commissions

Investigated daily variances in expenses and purchase reports, correcting errors to resolve discrepancies

Input financial data and produced reports using the M3 system

Communicated with suppliers to reconcile invoice payments

Investigated and resolved discrepancies in monthly bank account reconciliations

Coordinated timely payments from vendors, clients, and account holders

Resolved vendor and employee inquiries about invoices and purchases through detailed research

Managed daily bookkeeping functions, including accounts receivable, accounts payable, banking reconciliation, and disbursements

Front Desk Receptionist

Sheraton Hotel &Conference Center - Framingham, MA 09/2014 – 03/2020

Welcomed guests and confirmed reservations and identification

Answered multi-line phone system and greeted callers professionally

Used the Light Speed system to process reservations, check-ins, and check-outs

Performed basic bookkeeping activities and implemented updates to accounting system

Calculated billings and posted charges to room accounts, reviewing charges with guests at checkout

EDUCATION

Bachelor of Computer Science

Computer Teacher Education Egypt University 2011

Professional Development

Framingham State University

TECHNICAL SKILLS

Systems & Software:

SAP (Athena), Veeva, Arpeges, Microsoft Office Suite

M3 Financial System, Light Speed

Enterprise Asset Management (EAM) System - Work Order Management

Industry Knowledge:

cGMP, CAPA, Effectiveness check

Visual Inspection

Deviation Management & Effectiveness Checks

Document Control & Regulatory Compliance

Process Improvement:

Continuous Improvement Methodologies (GPS3)

Inventory Management & Cost Reduction

Cross-functional Team Collaboration

Toastmaster Member (May 2026 – Present) - Developing communication and leadership skills

PROFESSIONAL TRAINING

University of California, Irvine – Online Coursework

Initiating & Planning Projects Managing Project Risks

Budgeting & Scheduling Projects Project Management

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