Lead Packaging Operator-1st Shift jobs in United States
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Cosette Pharmaceuticals, Inc. · 13 hours ago

Lead Packaging Operator-1st Shift

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. The Lead Packaging Operator provides technical and administrative support to Packaging personnel and Management, ensuring optimal operation of packaging lines and compliance with quality standards.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Must promote positive work environment in Packaging Operations
Must be able to effectively communicate with representatives from cross functional team (Technical Services, Quality Assurance, Operations, Warehouse) regarding routine activities in Packaging Operations
Must possess and maintain the Packaging Trainer designation year over year throughout the course of employment as a Packaging Line Leader
Must provide necessary training to all new hires and existing packaging operators on all tasks in Packaging Operations
Operate and assist in set up of the packaging equipment and accurately perform all quality checks and documentation per company SOP's, SOF's and cGMP's
Must be able to perform routine adjustments to the packaging equipment to ensure optimal operation of the packaging lines
Monitor and report daily shift output for the assigned packaging line
Responsible for ensuring that shift output targets for the assigned packaging line are met on daily basis to meet department goals. Required to report daily shift outputs to Management daily
Manage position assignment and rotation of operators on assigned packaging lines
Responsible for directing activities for other packaging operators on the assigned packaging line on daily basis
Assist Packaging Supervisor with the allocation and reallocation of Packaging Operators to different Packaging Lines during the shift
Assist Supervisor with coordination of weekly/monthly departmental SOP training:
To ensure packaging training is completed in a timely matter
Ability to demonstrate and train on departmental procedures
Perform required Oracle inventory transactions for record set-up of components; capable of reviewing transactions for accuracy and corrections if needed
Recognize and report any product quality-related deficiencies
Initiate Do Not Ship Authorizations, In-Process Test Procedure, defect assessment forms, Sampling Form, and Change Controls
Provide necessary guidance to packaging operators on assigned packaging line on execution of In-process Test Procedures, Sampling Inspections, and Repack/Re-work activities
Audit packaging lines for correct SOF revisions
Review completed pages of the Equipment / Packaging Line Logbooks, SOF’s for accuracy and completeness and make the necessary corrections if needed
Assist in the Packaging End of run record review and assist in the preparation of records for the packaging lines
Review all in-process and completed records for accuracy and completeness
Resolve packaging errors within a timely matter
Provide necessary guidance to other operators on assigned packaging line when correcting documentation errors
Demonstrate mastery of all equipment safety features including the ability to start and stop all filling and packaging equipment
Perform / Verify line clearance, bulk product, and literature to prevent product / literature mix-up
Must have completed Advanced Operator training for the Serialization system. Knowledge of Serialization and Optel equipment responding to faults
Make oneself readily available to answer Packaging questions and assist other Packaging Operators in the packaging process
Initiate maintenance work orders
Must always adhere to current gowning procedures when in designated GMP areas
Maintain overall cleanliness and organization of packaging areas
Other duties as assigned by management
Must be willing or have the capability for the use of tools, machinery, facility equipment (pallet jacks/electric pallet jacks), office computer/laptop and all the required operating systems needed to operate the Packaging Department
Must be willing to sit or stand for long periods of time with occasional bending or squatting. Employee must be able to perform the basic life operational functions such as climbing, balancing, stooping, kneeling, crouching, crawling, reaching, standing, walking, pushing, pulling, lifting, grasping, feeling, talking, hearing and repetitive motions

Qualification

CGMP knowledgeOracle knowledgeSerialization equipmentPharmaceutical experienceTraining abilityTroubleshooting skillsCommunication skillsTeamworkTime managementSelf-motivated

Required

High School diploma or equivalent
Must promote positive work environment in Packaging Operations
Must be able to effectively communicate with representatives from cross functional team (Technical Services, Quality Assurance, Operations, Warehouse) regarding routine activities in Packaging Operations
Must possess and maintain the Packaging Trainer designation year over year throughout the course of employment as a Packaging Line Leader
Must provide necessary training to all new hires and existing packaging operators on all tasks in Packaging Operations
Operate and assist in set up of the packaging equipment and accurately perform all quality checks and documentation per company SOP's, SOF's and cGMP's
Must be able to perform routine adjustments to the packaging equipment to ensure optimal operation of the packaging lines
Monitor and report daily shift output for the assigned packaging line
Responsible for ensuring that shift output targets for the assigned packaging line are met on daily basis to meet department goals. Required to report daily shift outputs to Management daily
Manage position assignment and rotation of operators on assigned packaging lines
Responsible for directing activities for other packaging operators on the assigned packaging line on daily basis
Assist Packaging Supervisor with the allocation and reallocation of Packaging Operators to different Packaging Lines during the shift
Assist Supervisor with coordination of weekly/monthly departmental SOP training: To ensure packaging training is completed in a timely matter
Ability to demonstrate and train on departmental procedures
Perform required Oracle inventory transactions for record set-up of components; capable of reviewing transactions for accuracy and corrections if needed
Recognize and report any product quality-related deficiencies
Initiate Do Not Ship Authorizations, In-Process Test Procedure, defect assessment forms, Sampling Form, and Change Controls
Provide necessary guidance to packaging operators on assigned packaging line on execution of In-process Test Procedures, Sampling Inspections, and Repack/Re-work activities
Audit packaging lines for correct SOF revisions
Review completed pages of the Equipment / Packaging Line Logbooks, SOF's for accuracy and completeness and make the necessary corrections if needed
Assist in the Packaging End of run record review and assist in the preparation of records for the packaging lines
Review all in-process and completed records for accuracy and completeness
Resolve packaging errors within a timely matter
Provide necessary guidance to other operators on assigned packaging line when correcting documentation errors
Demonstrate mastery of all equipment safety features including the ability to start and stop all filling and packaging equipment
Perform / Verify line clearance, bulk product, and literature to prevent product / literature mix-up
Must have completed Advanced Operator training for the Serialization system. Knowledge of Serialization and Optel equipment responding to faults
Make oneself readily available to answer Packaging questions and assist other Packaging Operators in the packaging process
Initiate maintenance work orders
Must always adhere to current gowning procedures when in designated GMP areas
Maintain overall cleanliness and organization of packaging areas
Must be willing or have the capability for the use of tools, machinery, facility equipment (pallet jacks/electric pallet jacks), office computer/laptop and all the required operating systems needed to operate the Packaging Department
Must be willing to sit or stand for long periods of time with occasional bending or squatting. Employee must be able to perform the basic life operational functions such as climbing, balancing, stooping, kneeling, crouching, crawling, reaching, standing, walking, pushing, pulling, lifting, grasping, feeling, talking, hearing and repetitive motions
Must be self-motivated
Ability to work with all levels of Operations and QA
Ability to conduct training
Fundamental knowledge of cGMP's is required
Good math, communication (written and verbal), time management, and troubleshooting skills
Ability to work within a Team Environment
Maintain all manufacturing areas in a clean and sanitary condition and in compliance with GMP's
Be able to occasionally lift up to 50 lbs
Ability to wear steel toed shoes
Obey and enforce all facility safety policies
Obey and enforce all company rules and policies

Preferred

Previous pharmaceutical experience is preferred
2+ years of experience preferred
Knowledge of Oracle (inventory system)
Knowledge of Optel and Serialization equipment - preferred

Company

Cosette Pharmaceuticals, Inc.

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Cosette Pharmaceuticals, Inc.

H1B Sponsorship

Cosette Pharmaceuticals, Inc. 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 (1)
2024 (8)
2023 (4)
2022 (1)
2021 (6)
2020 (8)

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
Hamilton LaneHayfin Capital Management
2024-07-17Secondary Market
2024-07-17Debt Financing
2018-12-01Acquired

Leadership Team

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Apurva Saraf
President & CEO
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Richard S Casten
SVP and Chief Financial Officer
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Company data provided by crunchbase