Quality Assurance Specialist I (2nd Shift, GMP)

Alcami Corporation; Charleston (SC); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

Alcami Corporation in South Carolina is seeking a Quality Specialist I to provide site quality support, performing document reviews, supporting audits and inspections, and helping develop quality SOPs. This role requires adherence to cGMP and regulatory requirements and offers on-site 2nd shift.

You will maintain quality databases, train staff, and collaborate with cross-functional teams to ensure quality and compliance across lab, manufacturing, and regulatory activities.

Qualifikationen

• B.S./B.A./M.S. in a related field with 0-2+ years relevant experience or equivalent.
• A.A.S. in a related field with 5+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Aufgaben

• Performs quality review of moderately complex documents, various types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Provides real-time, on-the-floor review of documentation.
• Supports client and regulatory agency audits and inspections, as needed.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Assists with the development or revisions to quality SOPs or other quality documents and/or reports as needed.
• Provides consultation on quality and compliance topics in areas of expertise.
• Provides training in quality and compliance topics in areas of expertise.
• Understands Quality Management Systems including Investigations, Corrective Actions, Change Control, etc.

Kenntnisse

SOP compliance

Regulatory concepts

Problem solving

Team collaboration

Attention to detail

Documentation

Ausbildung

B.S./B.A./M.S. in related field

A.A.S. in related field

Tools

ERP

EDMS

MS Word

PowerPoint

Excel

Jobbeschreibung

Alcami Corporation in South Carolina is seeking a Quality Specialist I to provide site quality support, performing document reviews, supporting audits and inspections, and helping develop quality SOPs. This role requires adherence to cGMP and regulatory requirements and offers on-site 2nd shift.

You will maintain quality databases, train staff, and collaborate with cross-functional teams to ensure quality and compliance across lab, manufacturing, and regulatory activities.