Job Description: The Production Operator reports to the Production Supervisor and will be responsible for compounding liquid and solid materials by weighing, blending mixing and filtering of chemicals by following standard operating procedures. Production Operators will also be responsible for training in filling and packaging operations.
The duties of the Production Operators include, but not are limited to:
Packaging: Read and understand standard operating procedures (SOP’s) and current good manufacturing practices (cGMP’s). Package products according to SOP’s and specifications. Verify batch record documentation. Print, Label and stamp products according to specifications. Reconcile labeling and/or packaging when batch is completed. Maintain lot segregation. Utilize AX software to transfer finished product to distribution. Report quality issues to supervisor.
Filling: Read and understand SOP’s and current cGMP’s. Fills product according to SOP’s and specifications. Maintain lot segregation for batches. Use of measuring equipment (i.e. scale, etc.) during processing. Use filling equipment and cleaning instruments. Reconcile batch, labeling and documentation for filling operations. Ensure product quality meets desired specifications. Report quality issues to supervisor.
Compounding: Read and understand SOP’s and current cGMP’s. Use compounding equipment and measuring devices during processing. Ability to work with liquids, chemicals, compounds, etc. to manufacture healthcare products. Ability to read, understand SDS’s, chemical labels and hazard warnings. Reconcile batch, labeling and documentation for compounding operations. Maintain lot segregation for batches. Report quality issues to supervisor.
- Must be able to stand up to 8-hours per shift and lift up to 30 pounds occasionally.
- Must be comfortable working in a fast paced environment
- Must be able to wear all required protective equipment (hair net, safety glasses, lab coat and shoe covers)
- Must be comfortable in a clean room environment (no makeup or jewelry allowed)
- Must have attention to detail and quality of work.
- Proficiency in English language: Must read and write English. Be able to demonstrate fluent English comprehension.
- High School Diploma or at least one-year equivalent experience.
- Relevant experience within manufacturing environments for: assembly, compounding, filling, packaging, cGMP’s, FDA regulation (CFR’s) preferred.
- Create, run, and post completed jobs in the computer system.
- Assure a quality output that consistently meets specifications and passes quality control inspection.
- Assist in monthly cycle count and records production counts in an accurate and timely manner.
- Ability to demonstrate technical ability with measuring devices (I.e. scales, calculator, etc.).
- Documents direct labor hours daily in an accurate and timely manner.
- Assure quality output that consistently meets specifications and passes quality control inspection.
- Record production counts in an accurate and timely manner.
- Analytical skills in math and chemistry.
- Team player
- Problem solver, revise procedures, process improvements and other departmental duties as required.