2nd Shift MQA Specialist - Aseptic Quality Leader

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

Benefits offered by this job

Comprehensive Medical, Dental, Vision

Tuition reimbursement

PTO with year-end company closure

Wellness programs and discounts

Job summary

Indivior is seeking a MQA Specialist on 2nd shift to provide quality oversight across manufacturing areas in a cGMP environment. The role focuses on in-process review, issue resolution, and final batch record approvals to meet release schedules.

You will perform routine environmental monitoring and gowning training, ensuring aseptic practices are followed and deviations are properly addressed. This role anchors patient safety and product quality in Raleigh, NC.

Qualifications

• Bachelor’s degree in science, engineering, or equivalent.
• Minimum 1 year in pharmaceutical (cGMP) environment with aseptic technique.
• Ability to get gown certified within 30 days.
• Physical requirements for standing, lifting, and movement as stated.
• Strong communication and teamwork abilities.

Responsibilities

• Provide quality oversight on all critical manufacturing processes on the floor.
• Review in-process batch records and resolve batch-related issues.
• Perform routine environmental monitoring for viable and nonviable particulates.
• Ensure compliance with cGMP, FDA, OSHA and other regulations.
• Coach aseptic technique and support risk mitigation in aseptic areas.

Skills

On-the-floor oversight

Independent decision making

Communication skills

Aseptic technique knowledge

Education

Bachelor’s degree in science or engineering

Job description

Indivior is seeking a MQA Specialist on 2nd shift to provide quality oversight across manufacturing areas in a cGMP environment. The role focuses on in-process review, issue resolution, and final batch record approvals to meet release schedules.

You will perform routine environmental monitoring and gowning training, ensuring aseptic practices are followed and deviations are properly addressed. This role anchors patient safety and product quality in Raleigh, NC.