Senior Aseptic Production Operator

Indivior; Raleigh (NC); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

PTO + holidays

Bonus program

Med/Dental/Vision/Life/Disability

HSA options

Adoption assistance

Tuition reimbursement

Concierge services

Voluntary benefits

Wellness programs

Discounts

Job summary

Indivior is hiring an Operator III, Aseptic Production to operate and monitor aseptic processing and test equipment, ensuring strict cGMP compliance and meticulous documentation. The role includes cleaning, data review, and collaboration with QA, maintenance, and operations teams.

Starting hourly pay ranges from $30.00 to $40.00, with comprehensive benefits, training, and growth opportunities in a regulated pharmaceutical environment. On-site role based in Raleigh, NC.

Qualifications

• High School Diploma required.
• Minimum five (5) years’ experience in a regulated environment.
• Gowning experience in a classified area is required.
• Understanding of Aseptic techniques required.
• Knowledge of cGMPs.
• Basic math and science skills and the ability to use a computer.
• Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills: both verbal and written.
• Attention to detail.
• Experience with batch records handling, and a broad understanding of pharmaceutical production.
• Mechanical aptitude preferred.

Responsibilities

• Complies with cGMP through adherence to SOPs, Master Batch Record Instructions, and company policies to produce parenteral products.
• Ensure training maintains compliance with the job role before performing any activities in the production operation.
• Ensures that the equipment is cleaned and maintained properly, and the work areas are clean and maintained as required.
• Responsible for reviewing raw cycle data to ensure process standards are met.
• Exercises sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.
• Communicates with Production management, Quality Assurance, Quality Control, Maintenance and Engineering staff pertaining to status of manufacturing operations.
• Monitors manufacturing cycles. Verify and document production activities both manually and on computer systems, including batch records, logbooks, etc.
• Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions or safety incidents.

Skills

Aseptic techniques

cGMP

Communication skills

Attention to detail

Batch records handling

Mechanical aptitude

Reading comprehension

Computer literacy

Education

High School Diploma

Tools

Computer

Job description

Indivior is hiring an Operator III, Aseptic Production to operate and monitor aseptic processing and test equipment, ensuring strict cGMP compliance and meticulous documentation. The role includes cleaning, data review, and collaboration with QA, maintenance, and operations teams.

Starting hourly pay ranges from $30.00 to $40.00, with comprehensive benefits, training, and growth opportunities in a regulated pharmaceutical environment. On-site role based in Raleigh, NC.