Aseptic Manufacturing Documentation Specialist

Alcami-5; Morrisville (NC); On-site; USD 30,000 - 47,000; Full time

Job summary

Alcami in Morrisville, NC is seeking an Associate Manufacturing Specialist to drive manufacturing documentation and batch record review in a fast-paced, cGMP environment. This on-site, first-shift role focuses on formulation and aseptic filling documentation to ensure on-time product release.

The position requires a Life Sciences degree and 1–3+ years in GDP environments; strong attention to detail, communication skills, and proficiency with Microsoft Office are essential.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 1–3+ years in a GDP environment; pharmaceutical or biotech experience preferred.

Responsibilities

• Receive, organize, and manage all formulation and aseptic filling batch records and associated documentation.
• Perform detailed review of batch records for accuracy, completeness, and compliance with cGMP and GDP.
• Identify, document, and facilitate resolution of discrepancies, errors, and missing information.
• Ensure timely completion of record review to meet batch release timelines.
• Provide feedback and training to manufacturing technicians to support right-first-time manufacturing.
• Perform logbook reviews and support corrective actions as necessary.

Skills

Batch record review

GDP knowledge

Attention to detail

Documentation skills

Communication skills

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Office

Job description

Alcami in Morrisville, NC is seeking an Associate Manufacturing Specialist to drive manufacturing documentation and batch record review in a fast-paced, cGMP environment. This on-site, first-shift role focuses on formulation and aseptic filling documentation to ensure on-time product release.

The position requires a Life Sciences degree and 1–3+ years in GDP environments; strong attention to detail, communication skills, and proficiency with Microsoft Office are essential.