Senior QA Lead: GMP Compliance & Audits (Night Shift)

Alcami Corporation

Morrisville (NC)

On-site

USD 90,000 - 130,000

Full time

9 days ago

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Job summary

Alcami Corporation in Morrisville, NC is seeking a Sr. Quality Assurance Specialist for a 12-hour night shift to drive GMP-compliant quality activities. You will review documents, perform audits, and support regulatory inspections while mentoring Ops staff to uphold quality culture.

The role requires a strong background in GMP, cGMP compliance, and experience with SOP development and quality systems. This on-site position emphasizes collaboration across departments and timely quality

Qualifications

Bachelor's degree in Chemistry, Biology or related field with 5-7+ years of GMP experience.
Experience with QA documentation, audits, and regulatory inspections.
Strong knowledge of cGMP and Annex 1 requirements.

Responsibilities

Performs quality review and approval of documents, data, protocols, and/or reports.
Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).
Performs visual inspection of parenteral product (requires qualification).
Performs internal quality audits and/or inspections.
Supports client audits and inspections, and regulatory inspections.
Maintains quality databases.
Assists with implementation and supports quality systems and training.