United Pharma Technologies Inc
We are seeking a detail‑oriented Microbiologist to support Quality Control Microbiology operations within a cGMP pharmaceutical manufacturing environment. This role is responsible for executing routine and non‑routine microbiological testing, environmental monitoring, and supporting investigations to ensure product quality and regulatory compliance.
Key Responsibilities
Perform routine microbiological testing including bioburden, endotoxin (LAL), sterility, and microbial identification
Execute Environmental Monitoring (EM) for classified manufacturing areas (cleanrooms, utilities, and personnel)
Trend and review microbiological and EM data in accordance with USP, EU GMP, and FDA requirements
Support deviations, OOS/OOT investigations, CAPAs, and root cause analysis
Prepare and review microbiology‑related documentation, test reports, SOPs, and protocols
Support media preparation, growth promotion testing, and media fills (aseptic simulations)
Participate in audits and inspections (FDA, internal, and client audits)
Ensure compliance with cGMP, data integrity, and safety standards
Required Qualifications
Bachelor’s degree in Microbiology, Biology, or related life sciences
2–5 years of experience in QC Microbiology within the pharmaceutical or biotech industry
Hands‑on experience with EM monitoring and microbial testing
Strong knowledge of cGMP, USP
,
,
,
,
, and Annex 1
Experience working in controlled/aseptic environments
Proficiency with documentation in GMP systems (paper‑based or electronic)
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Pharmaceutical Manufacturing
#J-18808-Ljbffr
Key Responsibilities
Perform routine microbiological testing including bioburden, endotoxin (LAL), sterility, and microbial identification
Execute Environmental Monitoring (EM) for classified manufacturing areas (cleanrooms, utilities, and personnel)
Trend and review microbiological and EM data in accordance with USP, EU GMP, and FDA requirements
Support deviations, OOS/OOT investigations, CAPAs, and root cause analysis
Prepare and review microbiology‑related documentation, test reports, SOPs, and protocols
Support media preparation, growth promotion testing, and media fills (aseptic simulations)
Participate in audits and inspections (FDA, internal, and client audits)
Ensure compliance with cGMP, data integrity, and safety standards
Required Qualifications
Bachelor’s degree in Microbiology, Biology, or related life sciences
2–5 years of experience in QC Microbiology within the pharmaceutical or biotech industry
Hands‑on experience with EM monitoring and microbial testing
Strong knowledge of cGMP, USP
,
,
,
,
, and Annex 1
Experience working in controlled/aseptic environments
Proficiency with documentation in GMP systems (paper‑based or electronic)
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Pharmaceutical Manufacturing
#J-18808-Ljbffr