Quality Assurance Specialist (Night Shift)

Alcami Corporation; Morrisville (AL); On-site; USD 65,000 - 90,000; Full time

Job summary

Alcami Corporation in Alabama seeks a Quality Specialist to provide site quality support and ensure regulatory compliance. You will review documents, support audits, and develop SOPs across lab and manufacturing areas.

The role requires GMP experience and strong documentation skills. This is an on-site night-shift position with responsibilities spanning quality reviews, training, and process improvements.

Qualifications

• GMP experience required.
• Environmental monitoring and critical utilities experience preferred for sterile operations.
• Strong knowledge of regulations and SOPs in area of responsibility.

Responsibilities

• Support manufacturing processes on the floor.
• Perform quality review and approval of complex documents and data.
• Support quality floor audits and inspections.
• Assist with client and regulatory agency audits and inspections.
• Provide quality evaluation and release of materials, products, equipment and facilities.
• Maintain quality databases and perform trend analysis.

Skills

Quality Assurance

Regulatory Knowledge

Documentation Review

Communication

Independent Work

Interpersonal Skills

Education

Bachelor's degree in Chemistry, Biology, or relevant field

Master's degree in relevant field

Tools

Microsoft Office

Job description

Alcami Corporation in Alabama seeks a Quality Specialist to provide site quality support and ensure regulatory compliance. You will review documents, support audits, and develop SOPs across lab and manufacturing areas.

The role requires GMP experience and strong documentation skills. This is an on-site night-shift position with responsibilities spanning quality reviews, training, and process improvements.