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Formulation Operator III

Company: Micro Typing Systems, Inc.
Location: Pompano Beach
Posted on: June 9, 2021

Job Description:

The Career PotentialOrtho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.The OpportunityAs we continue to grow, we are seeking a Formulation Operator III who will have responsibility for the formulation of Gel Bottle Product intermediates used in the production of Gel Cards manufactured by Ortho Clinical Diagnostics at the Pompano Beach, Florida Facility. This involves solution and buffer formulations, antibody dilutions and gel bottle formulations. This position also provides support to the manufacturing department in the preparation, processing, and issue of Gel Filling components for use in Gel Card production. This position is located in Pompano Beach, Florida.The ResponsibilitiesPerform weighing of chemicals for use in the compounding of various buffers, solutions and dyes. Perform pre filtration of buffers. Perform various Monoclonal Antibody dilutions. Formulate prototype blend dilutions and final dilutions of Polyclonal Antibodies. Perform chemistry testing of solutions/buffers, diluted Polyclonal and Monoclonal Antibodies and finished gel bottle products. Perform day of use testing and calibration of chemistry testing equipment and testing of all solutions/buffers, diluted antibodies and finished gel bottle products.Perform antibody addition to gel, gel bottle rolling and sampling to create various types of Monoclonal, Polyclonal and other gel bottle products in a Microbiologically Controlled Filling Room under CGMP guidelines. Perform Sodium Azide treatment of incoming gel including addition, removal, labeling and gel bottle rolling. Perform filter integrity testing of intermediates.Perform automated and manual cleaning processes for formulation equipment used by the Gel Card Manufacturing Department. Prepare, inspect and issue production kit components including Gel Filling Lines and Piston and Housings, and assemble new gel filling lines used in the production of gel card products. Responsible for all documentation associated with this process.Review formulation documents to ensure quality and completion. Ensure formulation department calibrations and maintenance of equipment are performed and completed in a timely manner. May be responsible for CAPA and Non-Conformances in Trackwise as needed. May initiate, write and revise procedures and specifications as needed and follow through with Change Control and implementation procedures. May be responsible for training designated personnel in departmental procedures, reviews documentation of training for completeness and content and promote cGMPs and proper safety and environmental practices.Perform sample evaluation of new Gel lots. Perform unpacking and incoming inspection of approved gel lots.Perform cleaning and environmental monitoring of Microbiologically Controlled Filling Area.Perform incoming inspection of Chemicals. Perform daily, weekly, monthly maintenance and testing activities associated with the Deionized Water System including quarterly sanitization the Water System.May lead projects and teams to address area efficiency, production and equipment improvements. May require creation and approval of protocols and plans. Documents and reviews test results according to approved procedures and specifications. Performs and reviews all support functions to ensure compliance with Department, Company and Government procedures/regulations.Clean and assemble manufacturing components using automated washer.The IndividualAssociates Degree in Science with minimum of 3 years experience in a regulated production environment with a minimum of 2 years in compounding and formulations, or a Bachelors Degree in Science with a minimum of 1 year of experience in a regulated production environment with experience in compounding and formulations.Must possess a thorough understanding of formulation processes in a highly regulated environment.Ability to perform cleaning and assembly activities of manufacturing componentsMust possess a thorough knowledge of Good Manufacturing PracticesStrong written and verbal communication skillsAbility to work independently on complex issues.Strong attention to detail, and accurate documentationStrong organizational skills.Strong interpersonal skills with ability to work in a team environmentThorough understanding of environmental and safety regulations surrounding chemicals and formulations.EOE/AA Disability/Veteran#LI-KS1

Keywords: Micro Typing Systems, Inc., Pompano Beach , Formulation Operator III, Other , Pompano Beach, Florida

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