Lead Packaging Operator-1st Shift

Cosette Pharmaceuticals Inc.•Lincolnton, NC

About The Position

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. Innovating every day.™ Basic Purpose: Provide technical and administrative support to Packaging personnel and Packaging Management.

Requirements

High School diploma or equivalent.
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.
Ability to wear steal toed shoes.

Nice To Haves

Previous pharmaceutical experience is preferred.
2+ years of experience preferred.
Must be self-motivated.
Ability to work with all levels of Operations and QA.
Ability to conduct training.
Knowledge of Oracle (inventory system)
Knowledge of Optel and Serialization equipment - preferred

Responsibilities

Promote positive work environment in Packaging Operations.
Effectively communicate with representatives from cross functional team (Technical Services, Quality Assurance, Operations, Warehouse) regarding routine activities in Packaging Operations.
Possess and maintain the Packaging Trainer designation year over year throughout the course of employment as a Packaging Line Leader.
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.
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.
Ensure 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.
Direct 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:
Ensure packaging training is completed in a timely matter.
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.
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.