GMP Documentation Lead: Batch Review & Compliance

August Bioservices, LLC; Nashville (TN); On-site; USD 60,000 - 90,000; Full time

Job summary

August Bioservices, LLC in Nashville, TN is seeking a Manufacturing Documentation Specialist to ensure accuracy, integrity and compliance of batch records used for disposition and release. The role collaborates with Manufacturing, Quality, and other teams in a fast-paced GMP environment.

The position emphasizes detailed review of documentation, data integrity and readiness for inspection, aligned with August Bioservices’ commitment to regulatory excellence and high-quality biologics development.

Qualifications

• GMP/CGMP knowledge and experience preferred.
• Detail-oriented with strong data integrity focus.
• Experience reviewing batch production records or manufacturing documentation a plus.

Responsibilities

• Supports GMP manufacturing by performing detailed review of batch production records and driving corrections.
• Collaborates with Manufacturing, Quality, and cross-functional teams to ensure documentation accuracy and regulatory compliance.
• Supports record release, continuous improvement and inspection readiness activities in a fast-paced, regulated manufacturing environment.

Job description

August Bioservices, LLC in Nashville, TN is seeking a Manufacturing Documentation Specialist to ensure accuracy, integrity and compliance of batch records used for disposition and release. The role collaborates with Manufacturing, Quality, and other teams in a fast-paced GMP environment.

The position emphasizes detailed review of documentation, data integrity and readiness for inspection, aligned with August Bioservices’ commitment to regulatory excellence and high-quality biologics development.