Senior Aseptic Production Operator | GMP Expert

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

Benefits offered by this job

Bonus program

401(k) and Profit-Sharing Plan

Employee Stock Purchase Plan - 15% DIS

Comprehensive Medical, Dental, Vision,

Life and Disability coverage

Tuition reimbursement

Wellness programs

Job summary

Indivior PLC is seeking an Aseptic Production Operator I in Raleigh, NC. The role entails operating aseptic processing and test equipment, maintaining sanitation and data records, and ensuring compliance with cGMP and SOPs.

The candidate should have at least five years in a regulated environment and gowning in classified areas. The position emphasizes meticulous data review, strong communication with cross-functional teams, and safe operation of production lines to deliver parenteral products.

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 ability to use a computer.
• Read, understand, interpret, and apply technical writing and instruction.
• Strong verbal and written communication skills.
• Attention to detail.
• Experience with batch records handling and pharmaceutical production.

Responsibilities

• Complies with cGMP, SOPs, and MBIs to produce parenteral products.
• Ensure training remains compliant before performing production activities.
• Maintain clean and sanitized work areas and equipment.
• Review raw cycle data to verify process standards.
• Communicate with Production, QA, QC, Maintenance and Engineering staff regarding status and issues.
• Monitor manufacturing cycles and document activities in batch records and logbooks.

Skills

Aseptic techniques

cGMP knowledge

Attention to detail

Strong communication

Mechanical aptitude

Reading technical writing

Analytical reasoning

Batch records handling

Data entry/computer use

Education

High School Diploma

Job description

Indivior PLC is seeking an Aseptic Production Operator I in Raleigh, NC. The role entails operating aseptic processing and test equipment, maintaining sanitation and data records, and ensuring compliance with cGMP and SOPs.

The candidate should have at least five years in a regulated environment and gowning in classified areas. The position emphasizes meticulous data review, strong communication with cross-functional teams, and safe operation of production lines to deliver parenteral products.