Pharmaceutical Operator II at Afton Scientific. LLC – Charlottesville, Virginia

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Essential Functions:

1. Perform manufacturing processes and operate production equipment, including, but not limited to: washers, autoclave, dry heat oven, heat sealers, vial washer, ultrasonic cleaner.

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 production area

Knowledge, Skills & Abilities

1. Ability to read and write English. Dress, speak and act in a professional manner

2. Physically able to stand for extended periods of time, mover 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 in close proximity 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; Associates or Bachelor’s degree desirable

2. One year of manufacturing experience required. Three years manufacturing experience or more strongly preferred.

3. Clean room experience preferred.