Batch Documentation Specialist - cGMP & GDP

Alcami Corporation; Morrisville (NC); On-site; USD 52,000 - 74,000; Full time

Job summary

Alcami is seeking an Associate Manufacturing Specialist to drive documentation integrity on the manufacturing floor in Morrisville, NC. You will handle formulation and aseptic filling batch records, ensuring accuracy, GDP compliance, and timely batch releases.

This on-site 1st shift role requires attention to detail, strong written and verbal communication, and the ability to train technicians and support audits.

Qualifications

• Bachelor’s degree required or equivalent experience.
• 1–3+ years in GDP environment.
• Pharmaceutical, biotech, or aseptic manufacturing experience preferred.

Responsibilities

• Batch records handling and review for formulation and aseptic filling.
• Review for accuracy, completeness, and GDP/cGMP compliance.
• Provide feedback and coaching to operators on documentation.
• Support audits with documentation records and metrics.
• Collaborate with Manufacturing, QA and Supply Chain on timelines.

Skills

Attention to detail

Verbal communication

Written communication

Microsoft Office

Education

Bachelor’s degree in Life Sciences or related

Tools

Microsoft Office

Job description

Alcami is seeking an Associate Manufacturing Specialist to drive documentation integrity on the manufacturing floor in Morrisville, NC. You will handle formulation and aseptic filling batch records, ensuring accuracy, GDP compliance, and timely batch releases.

This on-site 1st shift role requires attention to detail, strong written and verbal communication, and the ability to train technicians and support audits.