On-Site Batch Records & Compliance Specialist

Alcami-5; Morrisville (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Alcami is seeking an Associate Manufacturing Specialist to drive results in a fast-paced, cGMP-compliant environment, manufacturing products according to protocol and ensuring documentation accuracy. You will handle formulation and aseptic filling batch records, uphold GDP practices, and support timely product release while collaborating with cross-functional teams.

On-site 1st shift with standard hours. The role emphasizes attention to detail, communication, and continuous improvement in a

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field; equivalent experience considered.
• 1–3+ years in GDP environment; pharmaceutical, biotech, or aseptic manufacturing operations work experience preferred.

Responsibilities

• Review and ensure accuracy of formulation and aseptic filling batch records.
• Identify discrepancies and ensure on-time batch release.
• Provide training to manufacturing technicians on documentation practices.
• Support internal and external audit readiness.
• Collaborate with Manufacturing, Quality Assurance, and Supply Chain to align on documentation needs.

Skills

GDP experience

Batch record handling

Attention to detail

Verbal & written communication

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related field

Tools

Microsoft Office

Job description

Alcami is seeking an Associate Manufacturing Specialist to drive results in a fast-paced, cGMP-compliant environment, manufacturing products according to protocol and ensuring documentation accuracy. You will handle formulation and aseptic filling batch records, uphold GDP practices, and support timely product release while collaborating with cross-functional teams.

On-site 1st shift with standard hours. The role emphasizes attention to detail, communication, and continuous improvement in a