Description

As a QC Microbiology Data Reviewer and Writer, you will be responsible for ensuring the integrity and compliance of quality control microbiology data. Your role involves performing thorough reviews of data related to bioburden, sterility, endotoxin, media qualification, and environmental monitoring. This position requires a meticulous approach to verify raw data and documentation, ensuring adherence to industry standards and company’s SOPs.

Company Culture and Environment

The role emphasizes quality, compliance, and teamwork. Working closely with analysts and supporting internal and external audits, you will contribute to a culture of accountability and precision where quality is the priority.

Career Growth and Development Opportunities

This position offers exposure to quality systems and compliance processes, providing a solid foundation for career advancement within the microbiology or quality assurance sectors. You will also gain experience in audit support and data integrity practices.

Detailed Benefits and Perks

While specific perks are not detailed, the position’s emphasis on thorough training and compliance suggests a supportive work environment conducive to professional development.

Compensation and Benefits

• Pay Rate: $55.95/hr (W2)
• Onsite position at Indianapolis, IN
• Monday - Friday, Business Hours (Weekends and Holidays as needed)

Why you should apply for this position today

This role offers a unique opportunity to ensure compliance and quality in a critical field. If you are passionate about microbiology and quality control, this is your chance to make a significant impact in a reputable organization.

Skills

• Strong knowledge of GMP microbiology laboratory data review
• Familiarity with Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring
• Experience in writing and supporting investigations, deviations, or CAPA processes
• Proficiency with Sherpa or other LIMS
• Intermediate level MS SharePoint experience
• SAP experience preferred

Responsibilities

• Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance
• Verify raw data, calculations, instrument outputs, and electronic records for various assays
• Ensure adherence to SOPs, test methods, and approved protocols
• Confirm compliance with ALCOA+ data integrity principles
• Identify discrepancies and collaborate with analysts to resolve issues
• Review EM results and escalate out of trend findings
• Write deviations, CAPAs, and revise SOPs
• Prepare monthly/quarterly reports for environmental monitoring
• Support internal and external audits with clear documentation

Qualifications

• Minimum 4 years experience in GMP microbiology laboratory data review
• Proven track record in microbiology compliance and data integrity
• Strong written communication skills for writing reports and SOPs

Education Requirements

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

Education Requirements Credential Category

• Relevant degree in microbiological sciences or related fields

Experience Requirements

• Minimum of 4 years of relevant experience in a GMP-controlled environment
• Experience in microbiology laboratory settings and data review processes

Why work in New Augusta, IN

New Augusta, IN, offers a blend of suburban tranquility with convenient access to urban amenities. Its welcoming community, local parks, and recreational opportunities make it an ideal place for professionals seeking a balanced lifestyle. With a focus on innovation and quality, New Augusta presents a supportive environment for career growth.