GMP Floor QA Specialist - Packaging & Compliance

Alcami Corporation; Michigan; On-site; USD 70,000 - 95,000; Full time

Job summary

Alcami Corporation is seeking a Plant QA Specialist to serve as the primary quality representative on the production floor, ensuring packaging operations meet SOPs, GMP requirements, and quality standards. The role conducts inspections, reviews batch records, supports material release and deviation management, and assists with CAPAs, investigations, and change controls.

The on-site, 4th shift (Friday–Sunday, 5:00am–5:30pm) provides real-time quality guidance and collaboration with production

Qualifications

• Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or related field.
• 2–3 years in QA, QC, or quality-focused support within pharmaceutical or regulated manufacturing.
• Experience performing shop-floor inspections and supporting production teams.
• Experience in a Pharmaceutical cGMP Environment is required for consideration.

Responsibilities

• Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards.
• Serve as the first point of contact for production teams on quality-related questions and issues.
• Provide real-time guidance and coaching to operators on GMP requirements and proper documentation practices.
• Conduct finished product checks and monitor production activities to ensure products meet release requirements.
• Review batch records and production documentation for accuracy, completeness, and compliance.
• Support inspection, approval, and release of packaging materials and bulk products.
• Maintain retain sample programs and support Right First Time (RFT) performance reporting.
• Create, review, and update SOPs, work instructions, forms, and training documentation.
• Review and approve minor deviations while ensuring timely and accurate documentation.
• Support investigations of major deviations through data gathering and root cause analysis.
• Assist with CAPAs, risk assessments, change controls, and other quality system activities.
• Guide production staff on deviation reporting processes and compliance expectations.
• Assist in developing and delivering GMP and quality-related training programs.
• Support implementation of process improvements to enhance quality, compliance, and efficiency.
• Participate in quality projects and help execute operational changes on the production floor.
• Collaborate with cross-functional teams to identify opportunities for improving procedures and reducing errors.

Skills

Quality Assurance

Quality Control

GMP Compliance

Documentation

Education

Bachelor's degree in Life Sciences

Tools

Document Management Systems

MS Office

Job description

Alcami Corporation is seeking a Plant QA Specialist to serve as the primary quality representative on the production floor, ensuring packaging operations meet SOPs, GMP requirements, and quality standards. The role conducts inspections, reviews batch records, supports material release and deviation management, and assists with CAPAs, investigations, and change controls.

The on-site, 4th shift (Friday–Sunday, 5:00am–5:30pm) provides real-time quality guidance and collaboration with production