Night-Shift MQA Specialist - Aseptic GMP Quality

Indivior; Raleigh (NC); On-site; USD 65,000 - 82,000; Full time

Benefits offered by this job

401(k) matching

Health, Dental, Vision coverage

Tuition reimbursement

Employee stock purchase plan

Job summary

Indivior is seeking a Manufacturing Quality Assurance (MQA) Specialist – 3rd Shift to provide quality oversight across manufacturing areas and ensure SOP/GMP compliance. You will perform in-process batch review, address issues, and support environmental monitoring in classified rooms.

The role requires a science/engineering degree, 1 year pharma/cGMP experience, and ability to obtain gown certification within 30 days. Competitive benefits and salary are provided.

Qualifications

• Bachelor’s degree in science, engineering, or equivalent experience.
• Minimum 1 year experience in the pharmaceutical industry (cGMP environment) and aseptic technique.
• Ability to obtain gown certification within 30 days.

Responsibilities

• Provide on-the-floor quality oversight for all critical manufacturing processes.
• Address daily quality concerns and questions related to operating and environmental issues.
• Communicate complex issues to Management clearly.
• Complete in-process batch record review and final batch record approvals to meet release scheduling.
• Perform aseptic gown training and certification sampling.
• Identify deviations and ensure proper initiation by responsible personnel.

Skills

Aseptic technique

cGMP experience

Gown certification

Documentation & batch records

Education

Bachelor’s degree in science/engineering

Job description

Indivior is seeking a Manufacturing Quality Assurance (MQA) Specialist – 3rd Shift to provide quality oversight across manufacturing areas and ensure SOP/GMP compliance. You will perform in-process batch review, address issues, and support environmental monitoring in classified rooms.

The role requires a science/engineering degree, 1 year pharma/cGMP experience, and ability to obtain gown certification within 30 days. Competitive benefits and salary are provided.