Machine Operator

Job Overview:

Pay Range: $20.30hr - $25.30hr

Requirement/Must Have:

• High School Diploma or equivalent.
• Prefer 1 year of work experience in a Manufacturing environment.
• Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Strong verbal and written communication skills.
• Basic math skills.
• Manufacturing experience in a regulated environment, with pharmaceutical experience being a plus.
• Mechanical aptitude, including the ability to assemble, disassemble, clean, and operate manufacturing equipment.
• Ability to follow Standard Operating Procedures (SOPs) and work safely within FDA, DEA, OSHA, and other regulated manufacturing guidelines.
• Willingness to complete the required training and certification process before working independently.
• Strong attention to detail and the ability to adapt to different production activities, including equipment operation, cleaning, changeovers, and solution preparation.

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.
• Operate pharmaceutical manufacturing equipment used in tablet production.
• Assemble and disassemble manufacturing equipment.
• Perform equipment cleaning and changeovers between product batches.
• Prepare solutions and support manufacturing processes.
• Follow Standard Operating Procedures (SOPs) and GMP requirements.

Nice to Have:

• Pharmaceutical experience.

Skills:

• Current Good Manufacturing Practices (cGMP).
• FDA Regulations.
• Equipment Troubleshooting.
• Batch Record Reconciliation.
• Mechanical Aptitude.
• SOP Compliance.
• Basic Mathematics.

Qualification And Education:

• High School Diploma or GED certificate.

Physical Requirements(Due to nature of job, The candidate must have):

• Ability to climb ladders using a lift or a ladder up to 15 ft.
• Ability to sit for regular periods.
• Ability to stand for regular periods.
• Ability to walk for regular periods.
• Ability to stoop, reach, and climb.
• Ability to move and lift 35 pounds or more.
• Ability to use a respirator if required.