Packaging Operator 2nd Shift

Department:

Packaging

Location:

110 Terry/100 Campus

Job Title:

Packaging Operator

FLSA Status:

Non-Exempt

1. Role Purpose:

The Packaging Operator performs packaging of pharmaceutical products according to all standard operating procedures (SOPs) and company policy and procedures, while also complying with cGMP, OSHA and DEA regulations and guidelines. This position works under the guidance of the Packaging Group Leader and reports directly to the Packaging Manager.

2. Key Duties & Responsibilities:

• Handle start up and shut down duties pertaining to the packaging equipment at the beginning and end of each shift.
• Operate packaging equipment in accordance with all company SOPs, including loading machines and tending machines during all phases of the packaging process.
• Ensure packing integrity by performing quality checks.
• Perform minor equipment adjustments to maintain product quality and maximum production.
• Read, review and maintain accurate batch record documentation.

Maintain a clean and orderly work area.

• Follow all safety procedures while operating equipment.
• Report any machine issues or malfunctions immediately to a mechanic or supervisor.
• Complete all line cleaning and end of day procedures as per GMP and company SOPs.
• Work cooperatively with others to meet daily production goals and quality standards.
• Maintain a positive attitude and works quickly to get things done.
• Follow all standard operating procedures (SOPs) accurately.
• Adhere to all cGMP, OSHA and EA regulations and guidelines.
• Work flexible work hours, based on business needs.
• Assist with the training of new employees.
• Other duties as required/assigned.
• Comply with FDA guidelines/Company Policies of Data Integrity

3. Education/Technical Competencies/ Certifications/ Licenses:

• Ability to read and comprehend documents such as batch records, operating instructions, SOPs and training materials.
• Proficient communication skills, both verbal and written.
• High School diploma or equivalent.

4. Physical Demand and Work Environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment

N/A