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EMAIL AVAILABLEPHONE NUMBER AVAILABLESkilled and dedicated manufacturing assembly professional with over ten years of progressive work experience in the laboratory and pharmaceutical equipment supply/ manufacturing industry. WORK EXPERIENCESpectraForce Staffing Agency Raleigh, NC May 2024 to present CSL Seqirus Holly Springs, NCProduction Operator Complete all production tasks according to GMP, QMS and Environmental Health and Safety (EHS) requirements. Operation of aseptic filling equipment in a clean room environment by using aseptic processing techniques, gowning and the correct use of sterilized equipment. Completing batch process sheets accurately and in real time. Perform and document in-process quality checks and batch process calculations according to Standard Operating Procedure (SOP) requirements. Actively participate to improve departmental processes and procedures. Randstad Raleigh, NC October 2023 to October 2024 Biogen Research Triangle Park, NCManufacturing Associate II (Subject Matter Expert) - Cell Culture / Upstream Worked in Media Prep/Buffer Prep where I prepared vessels using DeltaV program to be transferred to tanks. Perform processing steps and manufacturing support activities in the Drug Substance facility at Biogen in Research Triangle Park (RTP). Perform critical upstream processing activities within Current Good Manufacturing Practice (cGMP) biosafety cabinets including:o Mammalian cell culture & harvest:Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L Performing thaws and splits utilizing Aseptic techniqueDispensing raw materials + batching of media & solutions Corning Life Sciences Durham, NCOperations Area Line Lead May 2022 to April 2023 Provide leadership by directing and supporting Manufacturing Associates in daily operations to ensure smooth product flow. Execute production orders successfully. Provides troubleshooting for basic equipment faults. Works with technicians and engineering on solving problems in areas. Lead machine training and complete training assessments for sign offs. Ensuring compliance with compliance with all policies, procedures, and ensuring resources are scheduled accordingly per the daily production plan.Cleanroom Associate I March 2020 to May 2022 Performs detailed assembly using numerous documented processes involving the use of chemicals, intricate parts, and application of surface treatment. Troubleshooting and monitoring output quality and quantity. Make adjustments where applicable; alleviating minor jams on production line and auxiliary equipment. Read and interpret basic product drawings for the assembly of product and kits. Performs routine monitoring and inspection activities per product specifications on products and finished lots. Completes production records. Packs product and performs final QA check to inspect final pack out. Tracks packed volumes and provide data to shift report. Manufacturing Associate I & II January 2014 to March 2020 Operating all equipment in my area in accordance with shift schedule. Making necessary machine adjustments. Perform daily housekeeping, waste removal, and end-of-lot line clearance duties. Record relevant data onto forms or via electronic data entry. Ensure accuracy and good documentation practices. Working with tools, cleaning equipment and chemicals following product. Assemble, package, label, palletize and stage product. Complete electronic inventory transactions.EDUCATIONNC State University Raleigh, NCBioWork Certificate ProgramCompleted 10/23Durham Technical Community College Durham, NCJanuary 2010 to May 2011 Technology of Electrical EngineeringGuilford Technical Community College Greensboro, NC August 2009 to December 2009 Technology of Electrical EngineeringNorth Carolina Agricultural and Technical State University Greensboro, NC August 1996 to December 1999 Computer Science CommunicationNorthern High School Durham, NCAugust 1992 to June 1996 High School DiplomaRELEVANT SKILLS:- Experience using LIMS, SAP, DeltaV, Sincaide- Experience completing SOPs and documenting work.- Advanced mechanical aptitude and knowledge of electrical/mechanical equipment- Excellent reasoning and mathematical skills- Ability to effectively communicate (written and verbal)- Understanding of manufacturing run cadence and order of shift activities- Knowledge of cGMP, safety and operational procedures- Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)- Demonstrated leadership and critical thinking skills |
