Shumega hayes

984-***-****

ad06i0@r.postjobfree.com ·

A dynamic and result oriented business professional who undertakes complex assignments, meets tight deadlines, and delivers superior performance. Skilled production technician with 15 plus years of direct experience maintaining a sanitary environment and following FDA, CFR 21 regulations DEA guidelines. Responsible for producing products such as MMR, Varicella and Zostavax while ensuring good quality of outgoing products. Cleanroom setting while having adherence to a wide variety of SOP’s and HMI’s. Demonstrates great leadership skills and reliability amongst my peers.

Experience

2021-2023

Production Tech, Meters Biopharma

● Hands-on set-up (assembly/disassembly), operation, repair, adjustment, and cleaning of production equipment including but not limited to: bead coating machines, compactors, granulators, blenders, tablet presses, printers, and material movement equipment

●Followed Master Batch Records for the manufacture of controlled, oral solid dose

●Efficiently, effectively, and safely clean, set-up, and operated machinery in the manufacturing area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines

●Prepare, verify, and load raw materials, blends, and ensure bulk product accountability throughout manufacturing processes

●Operated various computer-controlled process support/process equipment (i.e. washer, autoclave, vial filler, lyophilizer, capping/inspect machines

●Clean and sanitize manufacturing and packaging rooms including walls, floors, and ceilings per SOPs

●Trained new associates on responsible processes

● Made adjustments as necessary to manual and automated filling equipment and machines using controls on an electrical control panel (HMI) (EBR) (DeltaV)(SAP)

●Performed scheduled quality checks, disposition product, identify any deviations that may occur

2012 – 2021

Production Technician, Merck & Co inc

●Serve as Subject Matter Expert for processing Lancer Washers, Stopper Vessels, Stabilizer, Autoclaves, Tanks, CIP/SIP and Component Preparation while managing multiple SAP storage bins

● Followed standard operating procedure for production

● Performed various housekeeping duties

● Conducted inventory control of all raw material

●Trained on 1600 stockroom and stockroom systems

● Daily tasks included shipping, packing, receiving, pulling orders, and use of SAP system

●Assisted in training new employees, and configuring computers to customer specifications

● Clean, prepare and sterilize production equipment using automated and or manual systems. Oversee activities to ensure proper maintenance, safety and cleanliness standards are followed when training new employees

●Effectively multitask while operating multiple systems such as Manufacturing Electronic Systems, Particulate Monitoring System, and handle Environmental Mentoring System.

● Properly perform operations review of processing documentation to ensure that errors were identified and corrected prior to final quality review.

2008-2010

Machine Operator/ Process TECHNICIAN, Genicom INC

●Operated various equipment

●Controlled contaminants in a clean room environment

●Followed standard operating procedure for production

●Performed various housekeeping duties

●Conducted inventory control of all raw material

●Verified materials

●Trained on 1600 stockroom and stockroom systems

●Daily tasks included shipping, packing, receiving,

●pulling orders, and use of POS system

●Performed cycle count and entered information into

●computer database

●Weighed and counted items for distribution within plan

●to ensure company standards

2004-2008

Supervisor/ Manager, In Style Urban Wear

●

●Overseer of daily operations which included employee supervision

●Ensured proper handling of product, shipping, and receiving

●Conducted inventory control of all materials

●Performed customer services functions with internal and external clients, which

●included communication to resolve issues, problems, and documentation

●Verified all request sheets on postal orders and

●supporting documentation

●Housekeeping duties

●Interviewed and trained employees

●Maintaining data and record keeping

●Ensured proper handling of product for shipping and receiving

1999 – 2004

Warehouse associate, SANMINA sci

●Performed auditing of areas for any missed counts, ordered and verified parts

●Assisted with training of new employees, and configuring computers to customer specifications

●Communicated order processing with foreign accounts in Mexico, Guatemala, and Canada

●Responsible for distributing work to the operators on the manufacturing lines

●Responsible for making sure all operators have daily tools and supplies

●Responsible for maintaining a clean and safe work environment

●Assisted with meeting daily production target

Skills

●ISO 9000/9001

●Calibration of various equipment

●Controlling contaminants

●Manufacturing safety (PPE)

●Shipping & Receiving

●Upstream and downstream processing

●Formulation

●OSHA Compliance

●Growing Cells

●Calibration Equipment

●Leadership

●Lab/ Cleanroom

●SAP

●Maximo

●Delta V

●eLIMS

Education

JAN 2012

Biotechnology, Vance Granville

June 2011

Cosmetology INSTRUCTOR, BEAUTY Academy

May 2010

Biowork CERTIFICATE, Durham Technical Community College

AUg 2004

Master Cutter, Dudley University

June 1998

COsmetology, Vance Granville Community

Certification

●Career Readiness Cert (CRC) Silver

●Yellow Belt Certification

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