Pharmaceutical Production Operator II

1. Perform manufacturing processes and operate production equipment, including, but not limited to, washers, autoclaves, dry heat ovens, heat sealers, vial washers, and ultrasonic cleaners.
2. Perform production operations according to Batch Records and Standard Operating Procedures (SOPs)
3. Maintain proper documentation (batch records, production logs, etc.)
4. Write and review master documents as applicable: SOPs and batch records
5. Write Operation Deviation Reports
6. Supervise contract production employees as applicable
7. Maintain inventory of control warehouse space
8. Perform production and maintenance activities in the Aseptic Processing Area (APA)
9. Write and edit documents, including procedures, deviations, master batch records, protocols, and reports, as necessary.
10. Perform initial assembly and review of completed production records for completeness.
11. Maintain order and cleanliness in the production area

Knowledge, Skills & Abilities

1. Ability to read and write English. Dress, speak, and act professionally.
2. Physically able to stand for extended periods, move objects up to 50 pounds, bend and reach to access equipment, have near vision correctable to 20/20, and be able to wear corrective eyewear to achieve this, if necessary.
3. Must be capable of working close to other employees, regardless of gender, in the confined environment of the production facility.
4. Must be capable of working in the clean room for uninterrupted extended periods
5. Ability to maintain neat and accurate records required
6. Must be able to work with minimal supervision.

Requirements for Education and Experience

1. Minimum of high school diploma or GED; Associate or Bachelor’s degree desirable
2. One year of manufacturing experience is required. Three years of manufacturing experience is more strongly preferred.
3. Clean room experience preferred.