Stage 4 Solutions
QC Microbiologist – Pharma (Onsite – Indianapolis, IN)
Stage 4 Solutions, Indianapolis, Indiana, us, 46262
QC Microbiologist – Pharma (Onsite – Indianapolis, IN)
1 week ago Be among the first 25 applicants
This range is provided by Stage 4 Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $52.00/yr - $55.94/yr
We are seeking a QC Microbiologist for a global pharmaceutical client. Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance.
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role at the client’s office in Indianapolis, IN.
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
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 SOP’s, 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 the first-time documentation
Review EM results and ensure proper escalation of out of trend or excursions findings
Write deviations, CAPAs and revise SOP’s
Write monthly / quarterly reports for environmental monitoring
Support internal and external audits by providing clear, complaint documentation
Requirements
Minimum 4 years’ experience in GMP microbiology laboratory data review
Knowledge of Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
Experience with Sherpa or other LIMS
Intermediate level MS SharePoint experienceSAP experience preferred
Preferred training in Quality systems, cGMP, and Data Integrity
Bachelor’s degree in microbiology, Biology or Biotechnology or equivalent.
Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the QC Microbiologist – Pharma (Onsite – Indianapolis, IN) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal‑opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $52/hr. - $55.94/hr.
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Analyst, and Information Technology
Industries
Business Consulting and Services
#J-18808-Ljbffr
This range is provided by Stage 4 Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $52.00/yr - $55.94/yr
We are seeking a QC Microbiologist for a global pharmaceutical client. Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance.
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role at the client’s office in Indianapolis, IN.
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
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 SOP’s, 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 the first-time documentation
Review EM results and ensure proper escalation of out of trend or excursions findings
Write deviations, CAPAs and revise SOP’s
Write monthly / quarterly reports for environmental monitoring
Support internal and external audits by providing clear, complaint documentation
Requirements
Minimum 4 years’ experience in GMP microbiology laboratory data review
Knowledge of Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
Experience with Sherpa or other LIMS
Intermediate level MS SharePoint experienceSAP experience preferred
Preferred training in Quality systems, cGMP, and Data Integrity
Bachelor’s degree in microbiology, Biology or Biotechnology or equivalent.
Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the QC Microbiologist – Pharma (Onsite – Indianapolis, IN) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal‑opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $52/hr. - $55.94/hr.
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Analyst, and Information Technology
Industries
Business Consulting and Services
#J-18808-Ljbffr