Katalyst CRO · 6 hours ago
Operator 1, Packaging Operations
San Diego, CA
Contract
Onsite
New Grad, Entry Level
0+ years expKatalyst CRO is a company specializing in clinical research and development, and they are seeking an Operator 1 for their Packaging Operations. The role involves filling liquid antibodies into vials in a laboratory environment, managing inventory, and ensuring safety and quality standards are met during the packaging process.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
This position IS NOT related to shipping OR shipment packaging
This is a manufacturing type position and involves filling of liquid antibodies into small vials in a laboratory environment and using lab instruments such as pipettes, peristaltic pumps, and analytical balances
Learn and understand: Basic Packaging process flow, Basic Inventory and supplies management process flow, Basic bottling techniques for all single vial purified and conjugate materials, Basic packaging processes including bagging and labeling, Use of pipette, scale and other packaging equipment as required, Support label creation process by learning and operating all labeling equipment
Meet daily/weekly/monthly departmental production objectives efficiently and effectively with a high degree of quality
Must have ability to independently organize individual schedules to meet departmental goals
Ability to follow general instructions on routine tasks and detailed instructions on new tasks
Support departmental packaging supplies and material management function including storing, retrieving, and staging supplies/materials as required
Support technical manual and technical data sheet preparation and operate associated equipment to produce printed literature
Support daily shift start up meetings
Understand and input packaging data, as required, in the SAP system and/or other Production Planning/Manufacturing Resource database system(s)
Follow all department guidelines and procedures
Follow Client Biosciences Environmental, Health and Safety (EH&S) policies and procedures
Take responsibility for safety in immediate work area
Participates in EH&S programs
Notify supervisors of all observed hazardous conditions or unsafe work practices
May provide recommendations on maintaining the safety of the work environment
Other duties as assigned by Supervisor
Qualification
Required
Liquid Dispense/PKG Equipment Pipettes, peristaltic pumps, analytical balances, etc
Math Skills: Ability to calculate fill volume based on concentration (mg/ml); understanding of the metric system
The Packaging Department processes material in a laboratory environment/production area with lab bench work surfaces for filling/dispensing research reagents into customer facing vials using electronic and manual pipettors
The packaging technician gathers the materials required for their order: liquid bulk reagent (antibody or buffer), vials/bottles, caps, paperwork, labels and prepares and organizes the starting materials accurately and then presents the production order setup for line clearance
A trained associate (Line Clearance Technician) then verifies the accuracy of the materials and paperwork then signs off on the paperwork to allow the Packaging Technician to proceed with the completion of the order
Weekly schedules are provided to the Packaging Technicians, with daily priorities indicated. The priorities can change, and Packaging Coordinators will relay any change in assignment priority to the Packaging Technicians
Packaging Technicians receive approximately 4-7 assignments per 8-hour shift
The orders vary in quantity from 8 inches to 1000-2000 each build sizes
Orders over 500 inches are assigned to have more than one technician to allow completion in a timely manner and allow the technicians to rotate the tasks for ergonomic safety
The Packaging Technician is required to wear long pants or skirt that covers the leg entirely down to the ankle, no visible skin exposed
Closed-toe and closed-heel shoes that cover the entire foot are required and no visible ankle/leg skin is allowed
Attire is casual with no ripped or torn clothing and must be appropriate for the workplace
The laboratory area requires a lab coat to be worn and gloves and goggles are required when performing benchwork that poses a spill or splash risk: bottling/filling, capping, transferring, measuring, etc
Technicians may stand or sit at the bench to perform their assignments
Most associates choose to stand to perform the filing, capping, labeling, and packaging activities
Packaging Technicians often stand for large kit assembly events and at times manage items up to 20-30 pounds, requesting assistance when required for ergonomic safety
Responsible for the manual inspection, labeling, and packaging of clinical and commercial products
Perform finished product packaging as required to satisfy all customer, internal, clinical, and other demands
Ensure finished product is packaged in accordance with procedures and Quality specifications
Inspect in-process packaging, components to ensure consistent quality and remove defective products and packaging material
Maintain timely and accurate documentation of manufacturing activities related to product packaging, including but not limited to device history records and inventory counts
Perform simple mathematical calculations required to assist in completion of batch records
Assist with inventory counting activities as required
Participate in safety audits as required and actively engage in daily safety discussions/observations. Perform routine cleaning of packaging station and processing equipment
Abide by all personal protective equipment and product contamination control (i.e. gowning) requirements
Handle hazardous waste as appropriate
High school diploma/GED
A minimum of 6 months of industry work experience required
Strong attention to detail
Work well in a team environment
Good documentation practice
Must be willing and able to work a flexible work schedule including static or rotating shifts and overtime as required
Familiarity with computers and various software for general business functionality
Must be able to perform basic mathematical calculations
Prescreening attachment required
Interviews - in person
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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