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The Clean Room Inspector/Packaging Operator, performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, and labeling. Responsibility includes inspection, cutting, packaging machine setup, entering production activities in Oracle MRP system and cleaning of clean room manufacturing equipment. All processing operations are performed in ISO Class 7 areas and require proper Clean Room gowning. All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations), Standard Operating Procedures (SOP’s) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughout.
This role is for first shift (7:00 a.m. - 3:30 p.m.)
SUPERVISION RECEIVED: Under the direct supervision of the Production Manager

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• High School diploma or equivalent.
• 0-2 years working in Medical Device or Pharmaceutical manufacturing industry. Production experience is highly desirable.
• Basic computer skills for email and data entry.
• Must work and collaborate as part of a team.
• Ability to operate, maintain and process equipment, and make adjustments as needed.
• Must read, write, and speak in English, and communicate clearly and concisely.
• Able to work independently with minimal supervision.
• Ability to gown to ISO Class 7 Clean Room standards.
• Able to participate in a team-oriented environment, willingness to assist and train others.
• Able to work independently with minimal supervision.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Responsible for accurately maintaining accurate records, required logs and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
• Performs and supports daily manufacturing operations inclusive of Cutting, Product Inspections, Packaging of product and cleaning of manufacturing equipment.
• Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
• Able to work independently with minimal supervision.
• Supports equipment evaluations and validation activities associated with the developed manufacturing processes
• Communicate with team members and support teams to ensure continuous production of the correct product at high quality levels with minimal wasted time and materials
• Responsible for performing precise measurements and using measurement equipment to accurately inspect product.
• Support department and plant Safety goals by continuously demonstrating safe behavior.
• Able to participate in a team-oriented environment, willingness to assist and train others.
• Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
• Maintain a clean and orderly work area.

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

• Daily interaction with hazardous materials used in a controlled environment