GMP Quality Specialist I — On-Site 2nd Shift

Alcami Corporation

South Carolina

On-site

USD 42,000 - 66,000

Full time

31 hours ago

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Job summary

Alcami is seeking a Quality Specialist I to provide site quality support in a fast-paced environment. You will review documents, support audits, maintain quality databases, and assist with SOP development while ensuring cGMP compliance.

The role emphasizes on-site collaboration with the Quality team and cross-functional partners. The position requires basic quality expertise, strong attention to detail, and effective communication to support continuous improvement and regulatory readiness across

Qualifications

Academic exposure to quality and regulatory concepts with potential for technical proficiency.
Able to comply with SOPs and regulatory compliance.
Good written and verbal communication skills.

Responsibilities

Performs quality review of moderately complex documents, data, protocols, and reports.
Supports quality floor audits and floor inspections.
Provides real-time on-the-floor review of documentation.
Supports client and regulatory audits and inspections as needed.
Maintains quality databases and may perform analysis and trending.
Assists with quality improvement initiatives as needed.
Assists with development or revisions to quality SOPs or reports.
Provides consultation on quality and compliance topics in areas of expertise.