Pharmaceutical Operator

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

Job summary

Afton Scientific, LLC is seeking a non-exempt Manufacturing Associate to perform fill/pack operations at our Virginia facility. You will operate production equipment, follow Batch Records and SOPs, and help maintain accurate production documentation.

Ideal candidates have a high school diploma or GED, at least 1 year manufacturing experience, and the ability to lift up to 50 pounds and work in a clean room. This role emphasizes adherence to quality and safety in a collaborative team setting.

Qualifications

• Reads and writes English for documentation and SOPs.
• Able to stand for long periods and lift up to 50 lb.
• Capable of working in a clean room and closely with others.

Responsibilities

• Perform manufacturing processes and operate production equipment per Batch Records and SOPs.
• Write and review master documents, deviations, and batch records.
• Supervise contract production employees as applicable.
• Maintain inventory in storage areas and ensure clean, organized production space.
• Complete production records and ensure accuracy and completeness.

Skills

English literacy

Physical stamina

Record keeping

Clean room work

Team collaboration

Education

High school diploma or GED

Associate or Bachelor 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.