Senior Quality Specialist: GMP Release & Compliance

Par Health, Inc.; Rochester (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Par Health, Inc. seeks a Senior Quality Specialist to review batch records and COAs, determine release readiness, and ensure timely quality holds when needed.

The role partners across departments to address errors, drives CAPA actions, and supports continuous improvement initiatives in a regulated manufacturing environment. Key responsibilities include on-the-floor MQAs, defect characterization, and collaboration with QA, manufacturing, and packaging teams.

Qualifications

• Bachelor's degree in a scientific, technical, engineering, quality, or related discipline.
• Minimum 7 years of experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Experience in Quality Assurance, Manufacturing QA, QC, inspection, or QA systems.
• Working knowledge of cGMP, GDP, FDA regulations and pharma quality systems.

Responsibilities

• Review batch records, production docs, and quality records for accuracy and compliance.
• Lead or participate in investigations, CAPAs, deviations, and change controls.
• Perform on-the-floor MQAs including line clearances, inspections, and material releases.
• Evaluate defects (visible particulates, cosmetic defects, closures) and classify as Critical/Major/Minor.
• Provide training and coaching on defect recognition and quality practices.

Skills

Quality Assurance

cGMP knowledge

Problem solving

Analytical thinking

Cross-functional collaboration

Technical writing

Training and coaching

Attention to detail

Decision making

Organizational skills

Education

Bachelor's degree in a scientific discipline

Tools

ERP systems

Microsoft Office

Quality management systems

Job description

Par Health, Inc. seeks a Senior Quality Specialist to review batch records and COAs, determine release readiness, and ensure timely quality holds when needed.

The role partners across departments to address errors, drives CAPA actions, and supports continuous improvement initiatives in a regulated manufacturing environment. Key responsibilities include on-the-floor MQAs, defect characterization, and collaboration with QA, manufacturing, and packaging teams.