QC Lab Technician - Data Integrity

Manpower; Rothschild (WI); On-site; USD 41,000 - 55,000; Full time

Job summary

Our client, a leading organization in the pharmaceutical and biotech industry, is seeking a QC Lab Technician - Data Integrity to join their team. This role focuses on ensuring data integrity through rigorous review of analytical data, notebooks, and electronic records, with emphasis on 21 CFR Part 11 compliance and continuous improvement.

The position involves leading root-cause investigations for data issues, maintaining calibration of precision equipment, and managing laboratory software

Qualifications

• 2 to 5 years of experience in a regulated cGMP lab (pharma/biotech/medical device).
• Strong knowledge of ALCOA+ principles and data lifecycles.
• Familiarity with electronic laboratory notebooks (ELN) and chromatography data systems (CDS).
• Experience with CSV and computer system validation.
• Ability to maintain data integrity and compliance.

Responsibilities

• Perform second-person peer review of analytical data, notebooks and electronic records for accuracy and completeness.
• Support electronic audit trails on standalone instruments and chromatography data systems to verify data integrity.
• Manage and support laboratory software systems in alignment with 21 CFR Part 11 regulations.
• Lead root-cause investigations for OOS results or data workflow failures and implement corrective actions.
• Maintain calibrations of precision equipment to ensure optimal performance and compliance.

Skills

ALCOA+

CSV

Data integrity

Root-cause analysis

Attention to detail

Tools

ELN

CDS

Job description

Our client, a leading organization in the pharmaceutical and biotech industry, is seeking a QC Lab Technician - Data Integrity to join their team. As a QC Lab Technician - Data Integrity, you will be part of the Quality Control Department supporting the Data Integrity team. The ideal candidate will demonstrate meticulous attention to detail, proactive problem-solving skills, and a commitment to maintaining high standards of compliance, which will align successfully in the organization.

Job Title:

QC Lab Technician - Data Integrity

Pay Range:

$30+/hr based on experience

Shift:

Evenings

What's the Job?

• Perform second-person peer review of analytical data, notebooks, and electronic records for accuracy and completeness.
• Seek involvement in continuous improvement activities and processes to support electronic audit trails on standalone instruments and chromatography data systems to verify data integrity.
• Manage and support laboratory software systems in alignment with 21 CFR Part 11 regulations.
• Lead root-cause investigations for out-of-specification (OOS) results or data workflow failures and implement corrective actions.
• Maintain calibrations of precision equipment to ensure optimal performance and compliance.

What's Needed?

• 2 to 5 years of experience working in a regulated cGMP laboratory (pharmaceutical, biotech, or medical device).
• Strong working knowledge of ALCOA+ principles, data lifecycles, and computer system validation (CSV).
• Familiarity with electronic laboratory notebooks (ELN), chromatography data systems (CDS), and root-cause analysis.
• Ability to operate all information technology related business systems, programs, and applications efficiently and accurately.
• Excellent attention to detail and organizational skills to support data integrity and compliance.

What's in it for me?

• Opportunity to work in a dynamic and compliant laboratory environment.
• Engagement in meaningful quality assurance activities supporting critical health and safety standards.
• Collaborative team environment fostering professional growth and development.
• Supportive management committed to your success and continuous improvement.
• Work schedule aligned with evening shifts, providing work-life balance.