GMP Batch Records Specialist

Piper Companies; North Carolina; Presencial; USD 41.000 - 62.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

Sick leave

401K

Descripción de la vacante

Piper Companies is seeking a detail-oriented QA Batch Record Reviewer in Durham, NC for an onsite, 6-month contract. The role focuses on GMP-compliant review of production records and close collaboration with manufacturing and quality leadership.

Responsibilities include documenting findings in electronic systems, supporting deviation management, and ensuring data integrity across manufacturing operations.

Formación

• Minimum of 1 year of batch record review experience within a regulated manufacturing environment; 3-5+ years preferred.
• Hands-on experience with Quality Management Systems (QMS) and electronic quality platforms; familiarity with multiple systems is highly desirable.
• Experience using ERP platforms such as SAP, Blue Mountain, or equivalent manufacturing and quality systems.
• Knowledge of GMP documentation practices, deviation management, exception tracking, and quality review processes.

Responsabilidades

• Perform detailed reviews of production batch records to ensure compliance with GMP requirements, internal procedures, and documentation standards.
• Partner with manufacturing personnel, supervisors, and quality leadership to investigate and resolve documentation discrepancies or record exceptions.
• Evaluate production records, supporting documentation, and associated quality events for completeness and accuracy prior to release activities.
• Utilize electronic quality and business systems to document reviews, track findings, and support workflow efficiency.
• Contribute to backlog reduction initiatives while maintaining a high level of accuracy and regulatory compliance across manufacturing operations.

Conocimientos

Batch record review

GMP compliance

QMS familiarity

Educación

Bachelor's degree preferred in life sciences

Herramientas

SAP

Blue Mountain

Descripción del empleo

Piper Companies is seeking a detail-oriented QA Batch Record Reviewer in Durham, NC for an onsite, 6-month contract. The role focuses on GMP-compliant review of production records and close collaboration with manufacturing and quality leadership.

Responsibilities include documenting findings in electronic systems, supporting deviation management, and ensuring data integrity across manufacturing operations.