Packaging Operator

Job Title: Material Handler (Packaging Operations) FLSA Classification: FullTime NonExempt/Hourly Professional

Work Location: Fall RiverMA

Work Hours: First Shift: 8:00 AM 5:00 PM (may vary based on business needs)

Purpose: The purpose of this role is to serve as a Packaging Operator/Material Handler in the packaging operations of InvaGen Pharmaceuticals Inc. at its 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 with respect to the department group and on an individual assigned basis to a sometimesspecific 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 to include 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 to established standards.

Essential Duties and Responsibilities:

Understanding basics of mechanical machinery and principles of control systems. Operating pharmaceutical packaging equipment with minimum rejection and maximum output maintaining quality standard 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 labelling 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 process.

Working individually and in collaboration with others as part of a team.

Executing procedures to complete tasks in a safe and efficient manner.

Completing documents on time ensuring accuracy and completeness.

Adhering to all cGMPs compliance/regulatory mandates and quality requirements.

Complying with company policies and procedures. InvaGen Pharmaceuticals Inc. a Cipla subsidiary550 South Research Place. Central Islip NY 11722Tel:Fax:Page 2 of 2

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 arises to the department head or reporting manager.

Performing daily maintenance on equipment and machinery.

Maintaining discipline in 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 trainings and retrainings 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 handling of machines.

Qualifications:

High school diploma or equivalent is required.

Advanced vocational training or education is preferred.

Minimum of one (1) year experience in packaging operations 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 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.

Ability to wear appropriate PPE is required.

Individual may be required to wear respiratory devices that include but are not limited to: Powered Air Purifying Respirators (PAPR) which include halfface and fullface negative pressure respirators hooded powered air purifying respirators or Supplied Air Respirators (SAR) which include hooded or full face supplied air respirators.