Job Description

JOB TITLE: Material Handler (Packaging Operations) FLSA
CLASSIFICATION: Full-Time, Non-Exempt / Hourly Professional 
WORK LOCATION: Fall River, MA, and Central Islip, NY
WORK HOURS: FIRST SHIFT: 8:00 AM – 5:00 PM (May vary based on business needs)
REPORTS TO: Facilities Operations Manager 

PURPOSE: The purpose of this role is to serve as a Packaging Operator / Material Handler in the packaging operations at the Fall River, MA project site.

SCOPE: The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role,
responsibilities, and expectations of the person assigned to perform the job. 
This job description is not designed to provide an exact or exhaustive list of all job duties, tasks,
skills, and qualifications. The intent is to give a general scope of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified concerning the department, group, and on an individual assigned basis to a sometimes-specific testing group. 
Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role. 

MULTIFUNCTIONAL ROLE: This job is a multifunctional role. The primary nature of this job is to serve as a Material Handler. As a secondary requirement, this position will be expected to provide support to other operational functions including but not limited to Warehouse Operations, Manufacturing Operations, and Facilities Operations.

JOB DESCRIPTION: The Material Handler performs all functions relating to the packaging of MDI products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements, and in conjunction with all Standard Operating Procedures (SOP). Incumbents in this position are responsible for the safe and efficient execution of their job duties while ensuring product compliance with established standards. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Understanding the basics of mechanical machinery and principles of control systems.
Operating pharmaceutical packaging equipment with minimum rejection and maximum output maintaining quality standards within standard norms.
Cleaning machines and area as per batch-to-batch and product-to-product change over
Performing operations and preventative maintenance of machines.
Identifying and assisting in the corrective actions of packaging-related issues.
Correcting status labeling at all stages of packing line with signature.
Ensuring that appropriate equipment calibrations are performed, and records are maintained.
Ensuring line clearance before initiating packaging activities in each area.
Wearing appropriate PPE as stated in the SOP before initiating the process.
Working individually and in collaboration with others as part of a team.
Executing procedures to complete tasks safely and efficiently.
Completing documents on time, ensuring accuracy and completeness.
Adhering to all cGMPs, compliance/regulatory mandates, and quality requirements.
Complying with company policies and procedures. 
Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
Performing other related duties as assigned.

OTHER RESPONSIBILITIES:
Maintaining 100% cGMP & Compliance during complete operation hours.
Must follow the Departmental SOPs.
Reporting all issues that arise to the department head or reporting manager.
Performing daily maintenance on equipment and machinery.
Maintaining discipline in the department.
May be required to assist in the training of other employees in the department.
Flexible to work extended hours, to achieve manufacturing schedule when needed. 

TRAINING AND SAFETY: 
All employees must undergo various training activities at the start of their employment. 
New training and re-trainings will occur periodically. 
Employees must strictly adhere to all safety, health, and environmental guidelines at all times and ensure that all safety precautions are being taken during the handling of machines. 

QUALIFICATIONS: 
High School Diploma or Equivalent is required.
Advanced Vocational Training or Education is preferred.
A minimum of one (1) year of experience in packaging operations is preferred.
Proficient in the English language (Speaking / Reading / Writing) to understand work instructions and document results.
Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment is highly preferred.
Basic understanding of mechanical machinery and the operating principles of control systems.
Ability to follow both verbal and written instructions.
Demonstrated ability to work in both independent and team environments.
Good knowledge of Health & Safety procedures, including, OSHA.
Strong mathematical and organizational skills. 

PHYSICAL REQUIREMENTS:
This position requires the ability to do heavy lifting/bending frequently.
Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull, or otherwise move objects.
The ability to wear appropriate PPE is required.
An individual may be required to wear respiratory devices that include but are not limited to Powered Air Purifying Respirators (PAPR) which include half-face and full-face negative pressure respirators, hooded powered air-purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Skills Required