QC Microbiology Data Reviewer and Writer

TSR Consulting; Indianapolis (IN); Sur place; USD 75 768 - 77 145; Temps partiel

Avantages offerts par ce poste

Medical insurance

401(k)

Referral bonuses

Résumé du poste

A leading staffing firm is seeking a QC Microbiology Data Reviewer and Writer for a contract role in Indianapolis, IN. The ideal candidate will have over 4 years of experience in GMP microbiology data review and strong knowledge of Bioburden, Endotoxin, and Sterility testing. Responsibilities include reviewing QC microbiology data, writing deviations and CAPAs, and supporting audits. This position offers a pay range of $55.00–$56.00 per hour and includes benefits such as medical insurance and a 401(k).

Qualifications

• Minimum 4 years’ experience in GMP microbiology laboratory data review.
• Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring.
• Preferred training in Quality systems, cGMP, and Data Integrity.

Responsabilités

• Perform independent review of QC microbiology data for compliance.
• Verify raw data and instrument outputs for assays.
• Identify discrepancies and work with analysts to resolve issues.

Connaissances

GMP microbiology data review

CAPA processes

Investigations

Data integrity

Good Manufacturing Practices (GMP)

Formation

Bachelor’s degree in microbiology, biology, or biotechnology

Outils

Sherpa or other LIMS

SAP

Description du poste

QC Microbiology Data Reviewer and Writer

Location: Indianapolis, IN.

Pay: $55.00–$56.00 per hour (W2).

Employment type: Contract (12+ months).

Seniority level: Associate.

Job function: Other. Industries: Pharmaceutical Manufacturing.

Base pay range: $55.00/hr – $56.00/hr.

(Please note local candidates only: Indianapolis IN ZIP 84025.)

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical company, is hiring for this role.

Responsibilities

• Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance.
• Verify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring.
• Confirm adherence to SOPs, test methods, and approved protocols.
• Ensure documentation meets ALCOA+ data integrity principles.
• Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right-first-time documentation.
• Review EM results and ensure proper escalation of out-of-trend or excursions findings.
• Write deviations, CAPAs and revise SOPs.
• Write monthly/quarterly reports for environmental monitoring.
• Support internal and external audits by providing clear, compliant documentation.

Qualifications

• Minimum 4 years’ experience in GMP microbiology laboratory data review.
• Experience with CAPA and deviations.
• Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring.
• Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
• Experience with Sherpa or other LIMS.
• SAP experience preferred.
• Bachelor’s degree in microbiology, biology or biotechnology or equivalent.
• Preferred training in Quality systems, cGMP, and Data Integrity.

Benefits (inferred)

Medical insurance.

401(k).

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