QC Microbiology Analyst - Contract
Randstad Enterprise, Durham, North Carolina, United States, 27703
Location:
Research Triangle Park (RTP), NC Foundation:
A 4-year degree (B.S.) in Microbiology, Biology, or a related scientific field. Experience:
Minimum of
2 years
of hands-on experience in a GMP Microbiology laboratory. Mindset:
A collaborative spirit and "quality-first" mentality. You have a sharp eye for detail and the analytical skills to catch a discrepancy before it becomes a problem. Flexibility:
Availability to work the 4x10 Sunday–Wednesday schedule and a willingness to support the business with overtime when needed. The Opportunity
Join our QC Microbiology team at our state-of-the-art drug substance manufacturing facility. In this role, you won't just be "testing samples"—you will be a vital guardian of patient safety. You will ensure the integrity of our manufacturing environment and the quality of the life-changing products we produce. We are looking for a detail-oriented scientist who thrives in a collaborative, fast-paced GMP environment and is eager to take ownership of critical buffer hold studies and environmental monitoring. Core Responsibilities
Microbiological Analysis:
Perform bioburden and endotoxin testing on in-process samples and environmental/utility monitoring (EM) samples. Data Integrity:
Accurately record all testing and plate results in
LIMS , ensuring strict adherence to SOPs, cGMPs, and safety guidelines. Buffer Hold Studies:
Lead the execution of ongoing buffer hold studies, serving as a key point of contact for Manufacturing Sciences. Cross-Functional Coordination:
Collaborate with the Microbiology Lead on scheduling and partner with Manufacturing to report results or excursions. Compliance & Investigation:
Monitor results against LIMS and SOP specifications; identify and initiate investigations for Out of Specification (OOS) or Out of Limit (OOL) results. Lab Stewardship:
Maintain a high-functioning lab environment by managing inventory levels and ordering supplies proactively. Technical Mastery:
Proven expertise in
Bioburden and Endotoxin
testing. Strong
Aseptic Skills
and the ability to accurately perform microbial enumeration (CFU). Proficiency using
LIMS
for data entry and result tracking.
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Research Triangle Park (RTP), NC Foundation:
A 4-year degree (B.S.) in Microbiology, Biology, or a related scientific field. Experience:
Minimum of
2 years
of hands-on experience in a GMP Microbiology laboratory. Mindset:
A collaborative spirit and "quality-first" mentality. You have a sharp eye for detail and the analytical skills to catch a discrepancy before it becomes a problem. Flexibility:
Availability to work the 4x10 Sunday–Wednesday schedule and a willingness to support the business with overtime when needed. The Opportunity
Join our QC Microbiology team at our state-of-the-art drug substance manufacturing facility. In this role, you won't just be "testing samples"—you will be a vital guardian of patient safety. You will ensure the integrity of our manufacturing environment and the quality of the life-changing products we produce. We are looking for a detail-oriented scientist who thrives in a collaborative, fast-paced GMP environment and is eager to take ownership of critical buffer hold studies and environmental monitoring. Core Responsibilities
Microbiological Analysis:
Perform bioburden and endotoxin testing on in-process samples and environmental/utility monitoring (EM) samples. Data Integrity:
Accurately record all testing and plate results in
LIMS , ensuring strict adherence to SOPs, cGMPs, and safety guidelines. Buffer Hold Studies:
Lead the execution of ongoing buffer hold studies, serving as a key point of contact for Manufacturing Sciences. Cross-Functional Coordination:
Collaborate with the Microbiology Lead on scheduling and partner with Manufacturing to report results or excursions. Compliance & Investigation:
Monitor results against LIMS and SOP specifications; identify and initiate investigations for Out of Specification (OOS) or Out of Limit (OOL) results. Lab Stewardship:
Maintain a high-functioning lab environment by managing inventory levels and ordering supplies proactively. Technical Mastery:
Proven expertise in
Bioburden and Endotoxin
testing. Strong
Aseptic Skills
and the ability to accurately perform microbial enumeration (CFU). Proficiency using
LIMS
for data entry and result tracking.
#J-18808-Ljbffr