GMP Data Integrity Specialist - Compliance & Traceability

Harba Solutions Inc.; St. Louis (MO); On-site; USD 60,000 - 80,000; Full time

Job summary

Harba Solutions Inc. is seeking a Data Integrity Specialist to ensure data accuracy and compliance in a fast-paced, regulated manufacturing environment in St. Louis, Missouri. The role encompasses reviewing documentation, supporting investigations, and collaborating with various teams to enhance quality systems.

The ideal candidate will hold a relevant degree and have experience in GMP environments, with strong attention to detail and excellent communication skills.

Qualifications

• Experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Working knowledge of GMP, GxP, and good documentation practices.
• Ability to identify documentation inconsistencies and compliance risks.

Responsibilities

• Review laboratory and manufacturing documentation for compliance.
• Support data integrity assessments and remediation activities.
• Investigate documentation discrepancies and data-related quality events.
• Assist with root cause investigations and corrective actions.
• Support audit readiness activities and participate in inspections.

Skills

Attention to detail

Verbal communication

Documentation practices

Investigation support

Education

Bachelor's degree in a scientific, engineering, quality, or related discipline

Tools

LIMS

QMS

EDMS

TrackWise

LabVantage

Job description

Harba Solutions Inc. is seeking a Data Integrity Specialist to ensure data accuracy and compliance in a fast-paced, regulated manufacturing environment in St. Louis, Missouri. The role encompasses reviewing documentation, supporting investigations, and collaborating with various teams to enhance quality systems.

The ideal candidate will hold a relevant degree and have experience in GMP environments, with strong attention to detail and excellent communication skills.