Data-Integrity QC Lab Technician (Evening Shift)

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. 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