Quality Control Data Review Specialist (2nd Shift)

Alcami-5; Morrisville (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Alcami is seeking a Quality Control Data Review Specialist to join the Laboratory Operations team. The role focuses on reviewing data and documents, conducting audits, and ensuring compliance with cGMP and regulatory requirements. The position may include training and mentoring others and supporting continuous improvement initiatives.

On-site, 2nd shift operates Wednesday to Saturday, 2:00pm – 12:30am. The ideal candidate has a chemistry or biology background with GMP experience and strong

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field with 2+ years GMP experience, or Master's with 1+ year related experience.
• Chromatography experience required.
• Method validation experience preferred.

Responsibilities

• Review and approval of data and documents (protocols, reports, test procedures).
• Maintain process KPIs and quality matrices as required.
• Support SOPs, work instructions, and other quality documents.

Skills

Chromatography

Independent work

Communication

Education

Bachelor's in Chemistry/Biology/related

Master's in related field

Tools

Microsoft Office

Job description

Alcami is seeking a Quality Control Data Review Specialist to join the Laboratory Operations team. The role focuses on reviewing data and documents, conducting audits, and ensuring compliance with cGMP and regulatory requirements. The position may include training and mentoring others and supporting continuous improvement initiatives.

On-site, 2nd shift operates Wednesday to Saturday, 2:00pm – 12:30am. The ideal candidate has a chemistry or biology background with GMP experience and strong