Pharmaceutical Manufacturing Machine Operator

Pay Range: $18.00hr - $23.00hr

Job Overview:

The candidate will be responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies, Good Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's). The role initially involves responsibilities such as preparing and cleaning drums, wiping equipment, staging materials, and learning the department's processes. The successful candidate will operate dispensing equipment and maintain accurate documentation within batch records and inventory systems.

Responsibilities:

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions.
• Perform dispensing and weighing of raw materials according to batch records, dispensing orders, and approved procedures.
• Verify material identity, lot numbers, expiration dates, quantities, and status labels prior to use.
• Operate dispensing equipment, scales, barcode systems, material handling devices, and associated systems.
• Maintain accurate documentation within batch records, logbooks, inventory systems, and electronic records.
• Complete reconciliation of materials, labels, and documentation.
• Monitor inventory levels and communicate material shortages or discrepancies.
• Perform line clearance, area readiness, and room status checks.
• Maintain cleanliness of dispensing rooms, equipment, and work areas.
• Perform basic troubleshooting and report equipment or process issues.
• Support investigations, deviations, CAPAs, and continuous improvement initiatives.
• Adhere to cGMP, GDP, safety, environmental, and quality requirements.
• Ensure 100% completion of assigned training.
• Communicate effectively during shift handoffs and with cross-functional teams.
• Support production schedules through timely material availability.
• Perform related duties as assigned.
• 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.
• Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
• Monitors product quality.
• Conducts in-process testing.
• Checks and adjusts calculations.
• Checks and reviews labels and batch records for accuracy.
• Follows established department SOP's and batch record instructions.
• Complies with all company policies and procedures, including safety rules and regulations.

Requirements:

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

• High School Diploma or equivalent with a minimum of 0-1 year relevant progressive manufacturing experience, preferably in the pharmaceutical industry.
• The candidate should be engaged, motivated, dependable, and interested in building a career within the pharmaceutical industry.
• The candidate must be comfortable working in a fast-paced environment and retaining information.
• At least 1 year of tenure in the last two positions held.
• 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.
• Ability to work independently as well as in a team environment.
• Knowledge of SOP's, cGMP's, equipment and safety practices.
• Experience with record keeping skills.
• Ability to use material handling equipment.

Screenings:

• Basic Background Check.
• 11 Panel Drug Screen including Fentanyl.
• Medical Screenings including Vision Screen (Near, Far, Color, Depth and Peripheral).
• Vital Signs and Urine Dip Analysis.
• Whisper Test.
• Audiogram and Noise and Hearing Questionnaire.
• Spirometry and OSHA Respirator Questionnaire.
• Lifting Assessment.

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

• Ability to climb ladders up to 15ft.
• Ability to roll pallets up to 75 pounds using lifters.
• Ability to lift 30 lbs.