Senior QC Data Integrity & Audit Readiness Specialist

Germer International; Bethlehem (Northampton County); On-site; USD 65,000 - 90,000; Full time

Job summary

Germer International is seeking a QC Data Integrity & Compliance Specialist to monitor electronic systems, support audits, and ensure cGMP/GDP documentation. You will perform analytical testing on in-process materials, raw materials, and finished products, while maintaining data integrity and preparing quality metrics.

The role emphasizes training, collaboration with auditors, and adherence to regulatory standards to support inspection readiness across QC activities.

Qualifications

• Bachelor's or Associate degree in science.
• 　
• 3+ years of QC lab experience.
• Knowledge of data integrity and electronic compliance.
• Experience with audits/inspections preferred.
• Familiarity with cGMP, quality and safety norms in regulated industry.
• Experience with SAP, LabX, TrackWise, CaliberLIMS preferred.

Responsibilities

• Monitor QC compliance with electronic systems and laboratory applications.
• Support audit readiness and review electronic records and audit trails.
• Assist in responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance Champion.
• Perform analytical testing of in-process materials, API, and finished products.
• Document work per cGMP and GDP.
• Maintain data integrity and regulatory compliance.
• Coordinate training and onboarding for new hires as required.

Skills

Data integrity

Audit readiness

Analytical testing

Laboratory systems

Regulatory compliance

Electronic records

Documentation

Communication

Training & coaching

Problem solving

Education

Bachelor's or Associate degree in science

Tools

SAP

MS Office

Ensur

Openlab

LabX

TrackWise

CaliberLIMS

Job description

Germer International is seeking a QC Data Integrity & Compliance Specialist to monitor electronic systems, support audits, and ensure cGMP/GDP documentation. You will perform analytical testing on in-process materials, raw materials, and finished products, while maintaining data integrity and preparing quality metrics.

The role emphasizes training, collaboration with auditors, and adherence to regulatory standards to support inspection readiness across QC activities.