Data integrity Specialist

Short Job Description:

Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA principles and regulatory standards (21 CFR Part 11, Annex 11).

• Review audit trails, monitor user access, and perform periodic data reviews.
• Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation.
• Perform titration-based content uniformity tests as per SOPs and pharmacopeial guidelines (USP, IP, BP); calculate active ingredient content and assess batch uniformity.
• Ensure compliance with GLP, GMP, and good documentation practices; maintain validated systems with secure electronic records and audit trails.

Detailed Description:

Data Integrity Compliance:

· Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon, etc.).

· Ensure adherence to ALCOA principles and regulatory requirements (21 CFR Part 11, Annex 11).

· Review audit trails, monitor user access, and perform periodic data reviews.

· Maintain accurate documentation of chromatograms, integration parameters, and calculations.

OOS Investigation:

· Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II).

· Conduct root cause analysis, hypothesis testing, and propose CAPAs.

· Document investigation narratives and track CAPA effectiveness.

Testing & Analysis:

· Perform titration-based content uniformity tests per SOPs and pharmacopeial guidelines (USP, IP, BP).

· Calculate active ingredient content and assess batch uniformity.

Documentation & Compliance:

· Ensure compliance with GLP, GMP, and good documentation practices.

· Maintain validated systems with secure electronic records, audit trails, and backup protocols.

· Review and approve titration method logs, normality calculations, and endpoint determinations.

Job Types: Full-time, Contract

Pay: $40.00 - $45.00 per hour

Work Location: Hybrid remote in Edison, NJ

Salary : $40 - $45