KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Reagent Fill Technician IV
Summary: Responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities. Participates in the filling, aliquoting, and packaging of bulk material into the final product.
Primary Responsibilities:
-Handling and traying of temperature-sensitive (semi-)finished goods for use in blood screening kits ·
-Perform inprocess visual inspection of temperature-sensitive (semi-)finished goods for use in blood screening kits as they come off the fill line before placement in trays.
-Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood screening kits for QC and Bio-burden.
-Receives and verifies the accuracy of materials transferred from the warehouse.
-Assists with material handling, folding product boxes/trays and staging of materials for process orders
-Understands and executes written procedures in accordance with cGMP.
-Performs labor transactions in the Enterprise Resource Planning (ERP) System.
-Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review.
-General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash.
-Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
-Maintains accurate and complete training records.
-Maintains and archives Manufacturing log sheet records. ·
-Demonstrate processes during audits, including ISO, FDA and internal audits.
-Follows all safety rules.
-Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines.
-Independently perform and lead the set-up and operation of reagent filling equipment of at least 90% of automated fill machines.
-Primary contact for material transfer delegation
-Implement new areas or ideas for 5S
-Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation
-Act as mentor and train Reagent Fill Technician I, Reagent Fill Technician II and Reagent Fill Technician III
-Lead equipment troubleshooting during the set-up, change over and operation to ensure completion within the scheduled time frame.
-Performs device history record review release and collaborates with Quality Assuance on any outstanding issues
-Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP) ·
-Work in cross-functional teams to lead process improvement projects within the filling department.
-Responsible for printing and distributing the cycle count forms, gathering and reviewing the completed forms, and investigating discrepancies Additional Responsibilities: -Cross-functional communication participation.
-Assists packaging crew as needed.
-Responsible for flushing water ports and eyewash stations.
-Adhere to target manufacturing timelines.
-Punctuality and attendance are required.
-Attentiveness and openness to learn new processes.
-Performs refrigerator/freezer maintenance.
-May cross-train in other areas of manufacturing and operations based on business needs.
-May mentor and help train Reagent Fill Technicians I, II and III.
-Assist with Device History Record (DHR) review.
-May be responsible for demonstrating manufacturing processes during a customer or regulatory audit.
-Initiate Quality Notifications (QN).
-Act as rework coordinator.
-Initiate lab walkthrough for audit preparation.
Education: Requires Associates Degree in Biology, Mechanics, Engineering or related field. Experience: 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment. 7 years minimum experience in a lab setting is highly preferred.
ABOUT KORE1
Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.
Kore1 provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kore1 complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Kore1 expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Kore1's employees to perform their job duties may result in discipline up to and including discharge.
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