Senior Quality Assurance Specialist - Night Shift

Alcami Corporation

Morrisville (NC)

On-site

USD 85,000 - 120,000

Full time

3 days ago

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Job summary

Alcami Corporation is seeking a Quality Senior Specialist to provide site quality support in a fast-paced environment, ensuring GMP compliance and regulatory readiness. You will review complex documents, support audits and inspections, and develop SOPs and quality reports.

This on-site, night-shift role follows a 12-hour rotating schedule (7:00pm–7:00am). Travel up to 5% and close collaboration with QA, manufacturing, and regulatory teams are required to maintain Right-First-Time quality and

Qualifications

BS/BA/MS in a related field with 8-12+ years relevant experience or equivalent.
AS in a related field with 15+ years relevant experience or equivalent.
Relevant GMP experience preferred.

Responsibilities

Performs quality review of complex documents, all types of data, protocols, and/or reports.
Supports quality floor audits and/or floor inspections.
Supports client and regulatory agency audits and inspections, as needed.
Develops quality SOPs or other quality documents and/or reports as needed.
Provides consultation on complex quality and compliance topics in areas of expertise.
Develops and provides training in quality and compliance topics in areas of expertise.
Understands Quality Management Systems including Investigations, Corrective Actions, Change Control, etc.
Maintains accurate files and records.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.