Quality Assurance Specialist I - GMP & Audits

Alcami Corporation; North Charleston (SC); In loco; USD 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Alcami Corporation is seeking a Quality Specialist I to provide site quality support across lab, manufacturing, and regulatory teams. You will review documents, support audits and inspections, maintain quality databases, and contribute to SOP development in a GMP environment.

The role emphasizes adherence to regulatory standards and effective on-site collaboration. The position is on-site with 2nd shift hours (2:30pm–11:30pm).

Competenze

• Requires a related degree (B.S./B.A./M.S. or A.A.S. with experience)
• GMP/regulatory knowledge preferred
• Strong documentation review and SOP development abilities
• Proficient with MS Office and data review
• Ability to work on-site and support audits/inspections

Mansioni

• Perform quality review of moderately complex documents and data
• Support floor audits and inspections
• Provide real-time on-the-floor document review
• Assist with client and regulatory agency audits/inspections
• Maintain quality databases and perform basic analysis/trending
• Assist with development or revision of SOPs and quality documents
• Provide training on quality and compliance topics
• Understand Quality Management Systems (Investigations, CAPA, Change Control)
• Maintain accurate files and ensure training requirements are met
• Travel up to 5% as needed
• Other duties as assigned

Conoscenze

Attention to detail

Problem solving

Team player

Communication skills

Regulatory compliance

Formazione

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

A.A.S. in a related field

Strumenti

ERP

EDMS

Microsoft Office (Word/Excel/PowerPoint)

Descrizione del lavoro

Alcami Corporation is seeking a Quality Specialist I to provide site quality support across lab, manufacturing, and regulatory teams. You will review documents, support audits and inspections, maintain quality databases, and contribute to SOP development in a GMP environment.

The role emphasizes adherence to regulatory standards and effective on-site collaboration. The position is on-site with 2nd shift hours (2:30pm–11:30pm).