QC Microbiology Data Reviewer & GMP Documentation Specialist
SOKOL GxP Services, Indianapolis, Indiana, us, 46262
QC Microbiology Data Reviewer & GMP Documentation Specialist role supporting GMP microbiology operations through independent
review of microbiology data ,
documentation , and
electronic records
to ensure accuracy, completeness, and
ALCOA+ compliance . The role focuses on review of
EM ,
bioburden ,
sterility ,
endotoxin , and
media qualification
data , along with
writing deviations, CAPAs, SOPs , and routine
GMP reports . Ideal for an intermediate-level professional (4–7 years) with
strong LIMS/GMP experience , working knowledge of
SharePoint , and exposure to
SAP .
Key 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 Required Qualifications
Minimum 4 years’ experience in GMP microbiology laboratory data review;
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;
Intermediate level MS SharePoint experience;
Education
Bachelor’s degree in microbiology, Biology or Biotechnology or equivalent;
Preferred training in Quality systems, cGMP, and Data Integrity.
Skills
SAP: 0–2 years (exposure required);
LIMS & GMP laboratory data review: 3–5 years;
Microsoft SharePoint: 3–5 years;
Microbiology assays data review (Bioburden, Endotoxin, Sterility, EM, Media Qualification);
Deviation, CAPA, SOP, and investigation writing;
ALCOA+ data integrity compliance.
Benefits Competitive hourly rate:
$47 – $55.9/hr (W-2 only, no C2C) .
Working Hours: Monday - Friday, regular business hours.
12-month contract with possible extension.
Health Insurance, Holiday Pay, 401(k) Program, And Other Benefits Employee referral bonus program
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review of microbiology data ,
documentation , and
electronic records
to ensure accuracy, completeness, and
ALCOA+ compliance . The role focuses on review of
EM ,
bioburden ,
sterility ,
endotoxin , and
media qualification
data , along with
writing deviations, CAPAs, SOPs , and routine
GMP reports . Ideal for an intermediate-level professional (4–7 years) with
strong LIMS/GMP experience , working knowledge of
SharePoint , and exposure to
SAP .
Key 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 Required Qualifications
Minimum 4 years’ experience in GMP microbiology laboratory data review;
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;
Intermediate level MS SharePoint experience;
Education
Bachelor’s degree in microbiology, Biology or Biotechnology or equivalent;
Preferred training in Quality systems, cGMP, and Data Integrity.
Skills
SAP: 0–2 years (exposure required);
LIMS & GMP laboratory data review: 3–5 years;
Microsoft SharePoint: 3–5 years;
Microbiology assays data review (Bioburden, Endotoxin, Sterility, EM, Media Qualification);
Deviation, CAPA, SOP, and investigation writing;
ALCOA+ data integrity compliance.
Benefits Competitive hourly rate:
$47 – $55.9/hr (W-2 only, no C2C) .
Working Hours: Monday - Friday, regular business hours.
12-month contract with possible extension.
Health Insurance, Holiday Pay, 401(k) Program, And Other Benefits Employee referral bonus program
#J-18808-Ljbffr