Night Shift QA Specialist - GMP Packaging

Alcami Corporation; Michigan; On-site; USD 65,000 - 90,000; 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 and GMP standards. The role includes reviewing batch records, supporting material release, and guiding deviation investigations on the 3rd shift.

Ideal candidates hold a Life Sciences degree with 2–3 years in QA/QC in regulated manufacturing, strong documentation skills, and familiarity with cGMP processes.

Qualifications

• Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or a related scientific discipline preferred.
• 2-3 years of experience in a Quality Assurance, Quality Control, or quality-focused support role within pharmaceutical, healthcare, or other regulated manufacturing environments.
• Experience performing shop-floor quality inspections and supporting production teams in a fast-paced manufacturing setting.
• At least three years of experience working within a Pharmaceutical cGMP Environment is required for consideration.

Responsibilities

• Shop Floor Quality & Production Support: Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards.
• Documentation, Batch Records & Material Control: Review batch records and production documentation for accuracy, completeness, and compliance.
• Deviations, Investigations & Compliance: Review and approve minor deviations while ensuring timely and accurate documentation.
• Training & Continuous Improvement: Assist in developing and delivering GMP and quality-related training programs.

Skills

Shop-floor inspections

Real-time quality guidance

Documentation & records

Quality system knowledge

Cross-functional communication

Education

Bachelor's degree in Life Sciences/related field

Tools

Microsoft Office

Document management systems

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 and GMP standards. The role includes reviewing batch records, supporting material release, and guiding deviation investigations on the 3rd shift.

Ideal candidates hold a Life Sciences degree with 2–3 years in QA/QC in regulated manufacturing, strong documentation skills, and familiarity with cGMP processes.