KEITH A. FORSEY

*** ********** *****: Phoenixville, PA 19460: 267-***-****: advc8a@r.postjobfree.com

Expert laboratory and manufacturing operations technician experienced in aseptic and clean room techniques in a Good Manufacturing Practice (GMP) facility, filtration devices, reactors, centrifuges, washers, autoclaves, vessels, dryers, agitators, and farm tanks eager to contribute management and operational expertise towards driving results and increased productivity with a reputable healthcare company.

SPO Operator – Merck & Co., Inc – West Point, PA 2/16 – Present

Department Shop Steward leading communication channels between union leadership, union members, and company representatives regarding new developments and issues within the collective bargaining unit.

Independently interact with departmental computer interfaces, SAP transactions, and troubleshoots machinery and equipment.

Run equipment for various size containers, stoppers, caps, and other packaging components.

Perform set-up, troubleshooting, and minor repairs of various equipment as necessary to complete operations.

Set up and operates steam and dry sterilizer equipment and thaw baths.

Prepare and operate lyophilization cabinets and perform loading and unloading.

Inspect and label handling tools and equipment associated with packaging.

Manage inventory of supplies, components, and equipment to meet production schedules and ensures material are optimally prepared for production operations.

Complete all required log sheets, batch records, training rosters, and other documentation with adherence to Right First Time (RFT) accountability.

Perform daily GEMBA on shop floor to ensure GMP.

Senior Laboratory Technician – WuXi App Tec – Philadelphia, PA 8/15 to 2/16

Performed the manufacturing process for Cell & Gene Therapy products, Master and Working Cell Banks and final product fills.

Demonstrated sound scientific and technical knowledge of manufacturing processes, contributed to the overall operations of the lab, and investigated deviation sources.

Mentored and provided operational guidance to junior manufacturing personnel to ensure compliance with standard operating procedures (SOP’s) and accuracy of batch records.

Mastered the regulatory compliance requirements for the production of biologics used in clinical studies and adhered to Good Manufacturing Practices and standard operating procedures.

Authored and evaluated batch production records, standard operating procedures, product specification sheets, adverse event reports, validation reports, master production records, and solution preparation records to ensure accurate and efficient manufacturing processes.

Participated in technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures.

Worked on routine and complex manufacturing assignments where independent action and a high degree of initiative were required in resolving problems and making recommendations.

Worked with senior manufacturing personnel to improve and optimize manufacturing methods.

Reviewed BMR’s with new associates during training and BPR’s.

Support Associate – Merck & Co., Inc – West Point, PA 8/12 to 7/15

Performed all tasks required to ensure a supply of sterile and/or cleaned equipment, which included CIP of equipment using manual and automated equipment washers and wash systems; Steam sterilization activities using autoclaves and Distributive Control Systems; and Depyrogenation activities using Dry Heat Ovens.

Supported management and technical personnel with start-up activities including the validation of manufacturing facility, qualification lots, and scale-up.

KEITH A. FORSEY

Prepared and sterilized growth media buffers and other solutions used in production process in compliance with manufacturing requirements and regulatory guidelines.

Managed operations and ensured inventory of all necessary production and support supplies through appropriate data management systems.

Observed and recorded production and test data for gauges, dials, and product characteristics, and managed controls to maintain appropriate temperature, pressure, and flow of ingredients.

Collected and examined product samples during production to test for quality, color, content, consistency, viscosity, acidity, or specific gravity.

Set up and operate production equipment such as agitators, reactors, centrifuges, vessels, and farm tanks.

Inside Pharmaceutical Sales – TelerX Corp./Merck & Co. - Horsham, PA 2/11 to 8/12

Conducted external customer interactions using multi-channel technology, supporting a customer centric business model to provide information about strategic campaigns, samples, and account services via telephone, email, live chat, social media or other method of communication.to support customer strategy.

Developed and maintained customer relationship and business opportunities with healthcare providers by giving prompt and accurate support, providing access to needed office resources, and demonstrating customer value.

Demonstrated strong ability to analyze relevant information to assess customer needs based on the practice structure and key influencers and make information available to relevant stakeholders.

Clinical Technician Contractor – Thomas Medical Group - Malvern, PA 6/10 – 12/10

Manufactured homeostatic introducers and vascular access for use in the medical device industry by following established protocols and SOP’s. Operated semi-automated and automated basic lab equipment. Regularly evaluated non-routine test results and either fail the product or allow it to continue through the production cycle.

Retail Business Development Sales Manager – Clear Wireless Internet - King of Prussia, PA 6/09 – 6/10

Achieved sales objectives, market share and productivity objectives, and managed expense and promotional resources.

Managed and coached a staff of retail sales representatives in a fast paced retail environment by focusing on morale, sales and growth goals, and meeting the customers' needs.

Analyzed and evaluated the continually changing and complex IT market in order that sound initiatives and objectives were established and led outbound sales efforts including store marketing activities and other special promotions to generate new sales.

Commercial Account Executive - Comcast Cable Communications, Inc. - New Castle, DE 11/01 to 6/09

Significant contributions led to the prestigious honor of being named Commercial Account Executive of the month for 8 consecutive rating cycles.

Established new customers through prospecting and implementing planned sales and growth strategies and tactics.

Demonstrated high initiative by proposing and coordinating special projects in and outside of assigned territory for commercial cable and high speed internet services.

Bachelor of Science - Business Administration, May 1992 - Temple University, Philadelphia, PA

Area of Concentration: Computer Information/ Business Administration

Merck Safety Committee

Merck Civil and Human Rights Committee

Sergeant, United States Marine Corp Reserve

Co-Founder, Project We Care – Youth Mentoring Program

Football Commissioner and Head Coach, MOT Youth Football Association

OBJECTIVE

PROFESSIONAL WORK EXPERIENCE

EDUCATION

AFFILIATIONS

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