GMP Audit Lead & Compliance Specialist

Alcami Corporation; North Charleston (SC); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Alcami Corporation is seeking a Sr. Compliance Specialist - Audit, GMP to lead on-site client audits and coordinate cross-functional responses. The role covers conducting audits, supporting inspections, and mentoring junior staff within a GMP-compliant quality system.

Hybrid work with on-site client audits and occasional travel to other sites is required. The ideal candidate will have extensive GMP experience, strong regulatory knowledge, and client-facing skills, with responsibilities including

Qualifications

• Bachelors or Masters with GMP experience.
• 10+ years GMP experience with Bachelors or 5+ years with a Master.
• Client hosting experience preferred.
• Client-facing experience required.

Responsibilities

• Host client audits and coordinate with clients.
• Coordinate with internal team members to complete responses.
• Write and coordinate audit responses.
• Perform quality review and approval of documents, data, protocols, and/or reports.
• Assist with supplier quality audits and inspections.
• Maintain quality databases and support quality systems.
• Consult with clients on regulatory issues.

Skills

Auditing

Regulatory knowledge

Client-facing

Communication

Mentoring

Education

Bachelor's degree in Chemistry/Biology

Master's degree (related field)

Tools

Microsoft Office

Job description

Alcami Corporation is seeking a Sr. Compliance Specialist - Audit, GMP to lead on-site client audits and coordinate cross-functional responses. The role covers conducting audits, supporting inspections, and mentoring junior staff within a GMP-compliant quality system.

Hybrid work with on-site client audits and occasional travel to other sites is required. The ideal candidate will have extensive GMP experience, strong regulatory knowledge, and client-facing skills, with responsibilities including