Pharmaceutical Operator II Job Charlottesville area,Virginia USA,Manufacturing / Production

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

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

Perform production operations according to Batch Records and Standard Operating Procedures (SOPs)

Write and review master documents as applicable: SOPs and batch records

Write Operation Deviation Reports

Supervise contract production employees as applicable

Maintain inventory of control warehouse space

Perform production and maintenance activities in the Aseptic Processing Area (APA)

Write and edit documents including: procedures, deviations, master batch records, protocols and reports as necessary

Perform initial assembly and review of completed production records for completeness

Maintain order and cleanliness in production area

Knowledge, Skills & Abilities

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

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.

Must be capable of working in close proximity to other employees, regardless of gender, in the confined environment of the production facility.

Must be capable of working in the clean room for uninterrupted extended periods

Ability to maintain neat and accurate records required

Must be able to work with minimal supervision.

Requirements for

Education and Experience

Minimum of high school diploma or GED;
Associates or Bachelor’s degree desirable

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

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