On‑Site Plant QA Specialist — GMP Quality on the Floor

Alcami-5; Michigan; On-site; USD 65,000 - 85,000; Full time

Job summary

Alcami is seeking a Plant QA Specialist to serve as the primary quality representative on the production floor, ensuring packaging operations comply with GMP, SOPs, and quality standards. Responsibilities include on‑floor inspections, batch record review, material release support, and contributing to investigations and CAPAs.

This 100% on‑site role requires collaboration with production teams, strong documentation skills, and a background in a pharmaceutical or regulated manufacturing

Qualifications

• Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or a related scientific discipline preferred.

Responsibilities

• Shop Floor Quality & Production Support: Perform daily quality inspections during packaging operations to ensure compliance with SOPs and quality standards.
• Documentation, Batch Records & Material Control: Review batch records and production documentation for accuracy and compliance.
• Deviations, Investigations & Compliance: Review and approve minor deviations and support major deviation investigations.

Skills

Batch records review

GMP knowledge

Documentation skills

Problem solving

Communication

Education

Bachelor's degree in Life Sciences or related

Tools

Microsoft Office

Document management systems

Job description

Alcami is seeking a Plant QA Specialist to serve as the primary quality representative on the production floor, ensuring packaging operations comply with GMP, SOPs, and quality standards. Responsibilities include on‑floor inspections, batch record review, material release support, and contributing to investigations and CAPAs.

This 100% on‑site role requires collaboration with production teams, strong documentation skills, and a background in a pharmaceutical or regulated manufacturing