Quality Assurance Specialist I - 2nd Shift (On-Site)

Alcami-5; Charleston (SC); Vor Ort; USD 45.000 - 65.000; Vollzeit

Zusammenfassung

Alcami in Charleston, SC seeks a Quality Specialist I to support site quality activities in a fast-paced GMP environment. You will review documents, support audits, maintain quality databases, and assist in SOP development while ensuring regulatory compliance.

This role emphasizes reliability, right-first-time execution, and collaboration with cross-functional teams. On-site 2nd shift (Mon-Fri 2:30pm-11:30pm) with travel up to 5% as needed.

Qualifikationen

• Academic exposure to quality concepts with potential to develop.
• Able to comply with SOPs and regulatory requirements.
• Basic knowledge of quality and regulatory concepts.
• Strong attention to detail and problem-solving.

Aufgaben

• Performs quality review of moderately complex documents and data.
• Supports floor audits and inspections.
• Provides real-time on-the-floor review of documentation.
• Supports client and regulatory audits and inspections.
• Maintains quality databases and may perform analysis.
• Assists with quality SOP development and revisions.
• Provides training on quality topics.

Kenntnisse

SOP compliance

Quality concepts

Right First Time

Attention to detail

Team collaboration

Problem solving

Communication skills

Ausbildung

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

A.A.S. in related field (5+ yrs)

GMP experience (preferred)

Tools

ERP

EDMS

Microsoft Word

PowerPoint

Excel

Jobbeschreibung

Alcami in Charleston, SC seeks a Quality Specialist I to support site quality activities in a fast-paced GMP environment. You will review documents, support audits, maintain quality databases, and assist in SOP development while ensuring regulatory compliance.

This role emphasizes reliability, right-first-time execution, and collaboration with cross-functional teams. On-site 2nd shift (Mon-Fri 2:30pm-11:30pm) with travel up to 5% as needed.