GMP Quality Assurance Lead — On-Site, 3rd Shift

Alcami-5; North Charleston (SC); On-site; USD 85,000 - 115,000; Full time

Job summary

Alcami is seeking a Senior Quality Assurance Specialist to drive GMP compliance in a fast-paced biopharma setting. You will review documents, perform audits, host inspections, and maintain quality systems to support manufacturing from discovery to commercialization.

You will mentor Operations staff, collaborate across departments to develop SOPs, and ensure timely regulatory readiness while upholding the company’s commitment to quality and reliable medicines.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field with GMP experience.
• Master’s degree in a related field is preferred.
• 5+ years of GMP-related experience required or more.

Responsibilities

• Performs quality review and approval of documents, data, protocols, and reports.
• Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).
• Performs internal quality audits and inspections and supports regulatory inspections.
• Maintains quality databases and assists with quality systems improvements.
• Mentors Operations personnel to achieve GMP compliance and quality culture.
• Interacts with clients on production and documentation, and develops SOPs.

Skills

Aseptic parenteral manufacturing

GMP experience

Annex 1 experience

20/20 Vision for Visual Inspector

Grade C gowning

Education

Bachelor’s degree in Chemistry or Biology or related field

Master’s degree in related field

Job description

Alcami is seeking a Senior Quality Assurance Specialist to drive GMP compliance in a fast-paced biopharma setting. You will review documents, perform audits, host inspections, and maintain quality systems to support manufacturing from discovery to commercialization.

You will mentor Operations staff, collaborate across departments to develop SOPs, and ensure timely regulatory readiness while upholding the company’s commitment to quality and reliable medicines.