Quality control Specialist

Job Title: QC Microbiology Data Reviewer and Writer

Location: Indianapolis, IN (Onsite)

Schedule: Monday–Friday, Business Hours (Weekends/Holidays as needed)

Pay Rate: $55.95/hr

Job Description:

Seeking a QC Microbiology Data Reviewer and Writer to support onsite quality operations in Indianapolis, IN. This role is responsible for independent review of microbiology QC data, ensuring accuracy, completeness, and compliance with cGMP and data integrity standards.

Key Responsibilities:

• Perform independent review of QC microbiology data for completeness, accuracy, and cGMP compliance

• Verify raw data, calculations, instrument outputs, and electronic records for assays including bioburden, sterility, endotoxin, media qualification, and environmental monitoring

• Ensure adherence to SOPs, test methods, and approved protocols

• Apply ALCOA data integrity principles to all documentation

• Identify discrepancies or atypical results and collaborate with analysts to resolve issues

• Review environmental monitoring data and escalate out-of-trend or excursion findings

• Write and support deviations, investigations, CAPAs, and SOP revisions

• Prepare monthly and quarterly environmental monitoring reports

• Support internal and external audits with clear and compliant documentation

Required Qualifications:

• Minimum 4 years of experience reviewing GMP microbiology data

• Strong knowledge of bioburden, endotoxin, sterility, media qualification, and environmental monitoring

• Experience writing deviations, investigations, CAPAs, and SOPs

• Hands-on experience with LIMS (Sherpa preferred)

• Intermediate MS SharePoint skills

Preferred Qualifications:

• SAP experience

• Training in Quality Systems, cGMP, and Data Integrity

Education:

• Bachelor’s degree in Microbiology, Biology, Biotechnology, or equivalent.