Senior QC Data Integrity & Compliance Specialist

Germer International - Pharmaceutical Recruiting

Allentown (Lehigh County)

On-site

USD 60,000 - 90,000

Full time

5 days ago
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Job summary

Germer International - Pharmaceutical Recruiting is seeking a QC Lab Data Integrity & Compliance professional to monitor compliance with electronic systems and perform analytical testing of in-process materials, API, and finished drug products. You will support audit readiness, investigations, and CAPA activities in a regulated environment.

The role requires strong data integrity, cGMP knowledge, and experience with computerized laboratory systems.

Qualifications

  • Bachelor's or Associate degree in science.
  • 3+ years of experience in a QC laboratory environment.
  • Knowledge of cGMP, quality and safety norms.
  • Experience with data integrity, electronic compliance, or computerized lab systems.
  • Familiarity with audits/inspections by internal, customer, or regulatory bodies.

Responsibilities

  • Monitor and support QC compliance with electronic systems and laboratory applications.
  • Support audits/inspections and responses to observations.
  • Maintain data integrity and complete quality metrics.
  • Perform analytical testing of in-process materials, APIs, and finished products.
  • Calibrate and troubleshoot laboratory instruments and document results.

Skills

Critical Thinking
Auditing & Compliance
Data Integrity Champion
Analytical communication
Collaboration

Education

Bachelor's degree in science
Associate's degree in science

Tools

SAP
MS Office
Ensur
Openlab
LabX
TrackWise
CaliberLIMS

Job description

Germer International - Pharmaceutical Recruiting is seeking a QC Lab Data Integrity & Compliance professional to monitor compliance with electronic systems and perform analytical testing of in-process materials, API, and finished drug products. You will support audit readiness, investigations, and CAPA activities in a regulated environment.

The role requires strong data integrity, cGMP knowledge, and experience with computerized laboratory systems.

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