Randstad Enterprise · 18 hours ago
QC Microbiology Analyst - Contract
Durham, NC
Contract
Onsite
Entry, Mid Level
2+ years expRandstad Enterprise is seeking a QC Microbiology Analyst to join their team at a drug substance manufacturing facility. The role involves performing microbiological analysis, ensuring data integrity, and leading buffer hold studies to maintain product quality and safety.
Human Resources
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
Qualification
Required
A 4-year degree (B.S.) in Microbiology, Biology, or a related scientific field
Minimum of 2 years of hands-on experience in a GMP Microbiology laboratory
A collaborative spirit and 'quality-first' mentality
Sharp eye for detail and analytical skills to catch discrepancies
Availability to work the 4x10 Sunday–Wednesday schedule and willingness to support the business with overtime when needed
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
Company
Randstad Enterprise
Randstad Enterprise is the leading global talent solutions provider, enabling companies to create sustainable business value and agility by keeping people at the heart of their organizations.
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase