Floor QA Specialist - Packaging & GMP Compliance

Alcami-5; Michigan; On-site; USD 65,000 - 90,000; 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 and SOPs. You will inspect, review batch records, and support material release, deviations, CAPAs, and change controls.

You will partner with production teams to provide real-time quality guidance, support continuous improvement, and uphold documentation standards in a fast-paced pharmaceutical environment on a 3rd shift.

Qualifications

• Bachelor's degree in Life Sciences or related field preferred.
• 2-3 years in QA, QC, or quality-focused support in regulated manufacturing environments.
• Experience performing shop-floor quality inspections in pharmaceutical manufacturing.
• At least three years of experience in a Pharmaceutical cGMP environment.

Responsibilities

• Perform daily quality inspections during packaging operations to ensure compliance with SOPs and GMP standards.
• Serve as the first point of contact for production teams on quality questions.
• Provide real-time GMP guidance and coaching on proper documentation practices.
• Review batch records and support material release activities.
• Support deviations, investigations, CAPAs, risk assessments, and change controls.
• Assist with training and continuous improvement initiatives on the production floor.

Skills

GMP knowledge

QA on the shop floor

Documentation

Problem-solving

Education

Bachelor's degree in Life Sciences

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 and SOPs. You will inspect, review batch records, and support material release, deviations, CAPAs, and change controls.

You will partner with production teams to provide real-time quality guidance, support continuous improvement, and uphold documentation standards in a fast-paced pharmaceutical environment on a 3rd shift.