Pharmaceutical Operator

Afton Scientific. LLC; Charlottesville (VA); On-site; USD 34,440 - 41,328; Full time

Job summary

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.

This non-exempt, on-site role offers $25–$30 per hour, depending on experience, and includes operating production equipment, writing and reviewing master documents, and maintaining clean and orderly production areas.

Qualifications

• Must read and write English.
• Able to stand for extended periods and lift up to 50 pounds.
• Capable of working with others in a production facility.
• Experience in a clean room environment preferred.
• Maintain neat and accurate records.
• Able to work with minimal supervision.

Responsibilities

• Operate production equipment (washers, autoclave, dry heat oven, heat sealers, vial washer, ultrasonic cleaner).
• Follow Batch Records and SOPs to perform manufacturing operations.
• Write/review master documents (SOPs, batch records).
• Write operation deviation reports.
• Supervise contract production employees as applicable.
• Maintain inventory in control warehouse space.

Skills

English literacy

Lifting 50 lb

Team collaboration

Clean room work

Record keeping

Self-motivated

Education

High school diploma or GED

Associate or Bachelor's desirable

Job description

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.

Pay Details

Non-exempt position, range of $25 - $30 per hour, depending on level of experience.

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. Write and review master documents as applicable: SOPs and batch records
4. Write Operation Deviation Reports
5. Supervise contract production employees as applicable
6. Maintain inventory of control warehouse space
7. Perform production and maintenance activities in the Aseptic Processing Area (APA)
8. Write and edit documents including: procedures, deviations, master batch records, protocols and reports as necessary
9. Perform initial assembly and review of completed production records for completeness
10. 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.