Pharmaceutical Operator

CvilleBioHub; Charlottesville (VA); Sur place; USD 21 000 - 30 000; Plein temps

Résumé du poste

Afton is seeking personnel for sterile manufacturing, packaging, and related lab services. The role involves operating production equipment, following batch records, and maintaining documentation in a controlled environment.

The ideal candidate has manufacturing experience, familiarity with clean rooms, and the ability to write and review SOPs and batch records in a regulated setting.

Qualifications

• Minimum of high school diploma or GED; Associates or Bachelor’s degree desirable.
• One year of manufacturing experience required; three years preferred.
• Clean room experience preferred.

Responsabilités

• Perform manufacturing processes and operate production equipment, including washers, autoclave, dry heat oven, heat sealers, vial washer, ultrasonic cleaner.
• Perform production operations according to Batch Records and SOPs.
• Write and review master documents such as SOPs and batch records.
• 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.

Connaissances

Manufacturing experience

Clean room experience

SOP familiarity

Formation

High school diploma or GED

Associates or Bachelor's degree desirable

Outils

Autoclave

Washer

Dry heat oven

Description du poste

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.

Key Responsibilities

• 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
• 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

Experience and Qualifications

• 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.
• Clean room experience preferred.