QA Specialist II (Nights 12 hour Rotating Shift)

About the Role

The Manufacturing Quality Assurance (MQA) Specialist supports the Manufacturing process and areas within a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists provide guidance to Manufacturing regarding process, safety, identity, strength, purity, and quality (SISPQ) of product, and risk management. They share responsibility for the inspection readiness of the site and work directly on the cleanroom floor with the Manufacturing team to offer real-time guidance and support. MQA Specialists collaborate on team initiatives and may coach or mentor to foster a GMP-compliant site.

Responsibilities

• Execute batch record review and approval
• Perform logbook review and approval
• Triage deviations and provide record guidance and generation
• Conduct routine facility walkthroughs
• Respond to facility issues compromising the clean environment
• Review and provide feedback on SOPs
• Reconcile bulk fill labels
• Respond to and acknowledge alarms
• Support external client review and resolution of comments

Requirements

MQA Specialist I

• High School diploma or equivalent; degree progression preferred
• 1–3 years of GMP, regulated industry, or laboratory experience
• Demonstrated ability to work in a team environment
• Understanding of the manufacturing process
• Ability to perform routine core MQA responsibilities
• Review written procedures for accuracy and provide feedback

MQA Specialist II

• Associate degree or Bachelor’s degree strongly preferred, or 4–6 years of relevant experience
• Demonstrated ability to work in a team environment with strong communication skills across all organizational levels
• Experience representing Quality in interdepartmental meetings
• Knowledge of technical documents
• Ability to become a qualified trainer
• Track and trend department metrics
• Review written procedures for accuracy and provide feedback