On-Site GMP Manufacturing Documentation Specialist

Alcami Corporation; Morrisville (NC); On-site; USD 60,000 - 75,000; Full time

Job summary

Alcami Corporation is seeking an Associate Manufacturing Specialist to drive documentation quality in a fast-paced aseptic manufacturing environment. The role focuses on handling, reviewing, and ensuring accuracy of batch records per cGMP and GDP guidelines.

You will ensure timely record reviews, provide coaching to operators, and support cross‑functional teams to sustain compliant release timelines. This on-site, first-shift position offers growth in a regulated facilities setting.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; equivalent experience considered.
• 1–3+ years experience in GDP/cGMP manufacturing or aseptic operations preferred.

Responsibilities

• Receive, organize, and manage batch records and associated documentation.
• Perform detailed review of batch records for accuracy, completeness, and compliance.
• Identify, document, and resolve discrepancies and missing information.
• Ensure timely completion of record reviews to meet batch release timelines.
• Provide feedback and training to technicians to support right‑first‑time manufacturing.
• Support logbook reviews and corrective action as necessary.
• Maintain GDP requirements and revision control across documents.
• Assist in audits readiness and documentation metrics.
• Train personnel on proper documentation practices.
• Collaborate with Manufacturing, QA, and Supply Chain.

Skills

Batch records

GDP compliance

cGMP

Documentation

Training

Cross-functional collaboration

Education

Bachelor's degree

Tools

MS Office

Job description

Alcami Corporation is seeking an Associate Manufacturing Specialist to drive documentation quality in a fast-paced aseptic manufacturing environment. The role focuses on handling, reviewing, and ensuring accuracy of batch records per cGMP and GDP guidelines.

You will ensure timely record reviews, provide coaching to operators, and support cross‑functional teams to sustain compliant release timelines. This on-site, first-shift position offers growth in a regulated facilities setting.