Operator 1, Packaging Operations

Katalyst CRO; San Diego (CA); On-site; USD 42,000 - 64,000; Full time

Job summary

Katalyst CRO seeks a Packaging Technician to support manufacturing of liquid antibodies in a laboratory setting in San Diego. You will operate pipettes, peristaltic pumps, and analytical balances, fill vials, bag and label products, and ensure compliance with EH&S policies.

You should have a science/manufacturing background, be detail oriented, and follow instructions. Daily tasks include packaging supplies management, SAP data entry, shift start-up briefings, and producing printed literature as

Qualifications

• High school diploma or GED required.
• At least 6 months of industry experience preferred.
• Must be detail oriented and able to work in a team environment.

Responsibilities

• Fill and package liquids into vials using lab instruments (pipettes, balances).
• Follow packaging processes including labeling and bagging.
• Meet daily/shift production objectives with high quality.
• Input packaging data into SAP and maintain accurate records.
• Assist with inventory management and daily documentation.

Skills

Attention to detail

Organizational skills

Safety awareness

Documentation

Education

High school diploma/GED

Tools

Pipettes

Peristaltic pumps

Analytical balances

SAP

Job description

• 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.
• A science and/or manufacturing background is required.
• 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.
• Takes responsibility for safety in immediate work area.
• Participates in EH&S programs.
• Notifies 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.

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.
• A science and/or manufacturing background is required.
• 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.
• Takes responsibility for safety in immediate work area.
• Participates in EH&S programs.
• Notifies 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.

Requirements

• 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 eaches to 1000-2000 each build sizes.
• Orders over 500 eaches are assigned 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 labcoat 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 demand.
• 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.

Qualifications

• 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 practices.
• 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.