2nd-Shift QA Specialist: GMP & Aseptic Oversight

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

Benefits offered by this job

Competitive PTO

Job summary

Indivior is seeking a MQA Specialist - 2nd Shift to provide quality oversight across manufacturing areas, ensuring GMP compliance and proper documentation. The role collaborates with production, reviews batch records, and supports aseptic processing while maintaining environmental monitoring and regulatory adherence.

The position requires a science or engineering degree, cGMP experience, gowning certification within 30 days, and the ability to manage multiple tasks with strong communication

Qualifications

• Bachelor’s degree in science, engineering field, or equivalent experience.
• Minimum one year of pharmaceutical industry (cGMP) experience.
• Ability to obtain gown certification within 30 days.
• Physical requirements include standing/walking up to 8 hours and lifting up to 35 pounds.
• Strong communication (oral, written) and interpersonal skills.
• Acceptable visual acuity test required.

Responsibilities

• Provide quality oversight for all manufacturing processes.
• Review in-process batch records and resolve batch-related issues.
• Complete gown qualification and maintain entry status for aseptic areas.
• Perform aseptic gown training and certification sampling.
• Conduct environmental monitoring of viable and nonviable particulate levels.
• Ensure regulatory compliance with 21 CFR Parts 210/211, cGMP, FDA, OSHA.

Skills

Communication skills

Attention to detail

Team collaboration

Problem solving

Education

Bachelor’s degree in science, engineering field, or equivalent experience

Job description

Indivior is seeking a MQA Specialist - 2nd Shift to provide quality oversight across manufacturing areas, ensuring GMP compliance and proper documentation. The role collaborates with production, reviews batch records, and supports aseptic processing while maintaining environmental monitoring and regulatory adherence.

The position requires a science or engineering degree, cGMP experience, gowning certification within 30 days, and the ability to manage multiple tasks with strong communication