QC Documentation & Data Integrity Lead

Nova Pneuma, Inc.; Fremont (CA); On-site; USD 145,000 - 177,000; Full time

Job summary

Nova Pneuma, Inc. seeks a qualified QC Documentation Compliance Lead to oversee all phases of data review, QC systems, and documentation management. The role requires directing data reviewers, ensuring data integrity, and maintaining inspection readiness across lab operations in a GMP environment.

Responsibilities include coordinating internal and external audits, managing compendial monitoring, and driving SOP updates while ensuring timely training and adherence to regulatory standards.

Qualifications

• BS degree in scientific field or equivalent.
• 5-7 years of data review experience.
• 8+ years of pharmaceutical experience.
• Knowledgeable in FDA Guidance, ICH Guidelines, and ISO certifications.
• QA experience reviewing documentation preferred.
• Advanced knowledge of GMPs, safety regulations and data integrity.

Responsibilities

• Manage the timely review of QC data processes to ensure data integrity and compliance with SOPs and specifications, audit data packages for scientific merit and GDP.
• Manage the data reviewers in QC Documentation Compliance group to ensure reviews are completed within timelines.
• Verify data transfer, calculations, and documented information such as instrument calibration, logbook entries, standards, controls.
• Compile and file QC data packages and reports in paper and electronic formats.
• Ensure monthly logbook audits are successfully conducted.
• Manage compliance activities related to internal and external audits.
• Conduct periodic informal laboratory audits to ensure inspection readiness.
• Address audit findings within defined timeframe.
• Oversee inspection readiness program with guidance from QC leadership.
• Verify analyses per test methods and compendial methods, compliant with GMP.
• Monitor compendial updates and propose actions.
• Ensure lab investigations are completed timely (root cause, deviations, NCRs).
• Generate or revise SOPs; track revisions to current, compliant procedures.
• Oversee QC document lifecycle management of SOPs, work instructions, test methods, specs.
• Complete training for QC systems SOPs timely.
• Oversee QC quality systems management (LIRs, deviations, CAPAs, etc.).
• Apply good documentation and good laboratory practices daily.
• Other duties as assigned.

Skills

Well-organized

Multi-tasking

Detail-oriented

Excellent communication

Independent worker

Follow detailed instructions

Collaborate in matrix environment

Time management

Education

BS degree in scientific field or equivalent

5-7 years of data review experience

8+ years of pharmaceutical experience

Knowledgeable in FDA Guidance, ICH Guidelines, and ISO certifications

QA experience reviewing documentation preferred

Advanced knowledge of GMPs, safety regulations and data integrity

Tools

MS Word

MS Excel

Job description

Nova Pneuma, Inc. seeks a qualified QC Documentation Compliance Lead to oversee all phases of data review, QC systems, and documentation management. The role requires directing data reviewers, ensuring data integrity, and maintaining inspection readiness across lab operations in a GMP environment.

Responsibilities include coordinating internal and external audits, managing compendial monitoring, and driving SOP updates while ensuring timely training and adherence to regulatory standards.