Operator I

Job Title

Job Overview:

Requirement/Must Have:

• High school diploma or GED certificate.
• Longevity in prior roles. Pharmaceutical and manufacturing experience is a plus.
• Strong verbal and written communication skills.
• Overtime will be required and can change week to week.

Responsibilities:

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Reports process or equipment problems to supervisor; performs minor or basic troubleshooting.
• Ensures batch records, equipment log books, and other relevant records are current.
• Performs batch record reconciliation.
• Maintains records of manufacturing process by recording data on batch record.
• Sets-up and operates equipment for processing operations.
• Communicates effectively with previous and incoming shift operator and related personnel.
• Cleans and maintains processing rooms and equipment.
• Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
• Monitors product quality.
• Performs reconciliations.
• Conducts in-process testing.
• Checks and adjusts calculations.
• Checks/reviews labels and batch records for accuracy.
• Suggests improvements in methodology or process.
• Understands concept of delivery/on-time production.
• Follows established department SOP’s and batch record instructions.
• Complies with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.

Skills:

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Effective oral and written communication skills.
• Basic math skills.
• Complying with all Company safety rules and regulations.

Qualification And Education:

• Prefer 0-1 year of work experience in a Manufacturing environment.
• Physical requirements include regular periods of sitting, standing, walking, stooping, reaching, and climbing, visual acuity to monitor and/or read, communicating orally with management, peers and co-workers, and occasional periods of moving and lifting a minimum of 35 pounds.
• Work is performed in a manufacturing environment with noise levels varying from moderate to loud depending upon machinery usage.
• Work performed may require the use of a respirator and incumbents may be subject to a Pulmonary Function Test (PFT) to determine eligibility for fit-testing.