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Quality Analyst I
The QC Analyst I has the responsibility to:
-Perform aseptic sampling Pilot Plant critical utilities and controlled environment
-Perform general laboratory maintenance activities such as cleaning, inventory, and ordering of laboratory supplies.
-Perform sample management such as logging samples into LIMS and performing sample reconciliation
-Perform basic laboratory assays such as viable and non-viable environmental monitoring, pH, and conductivity in compliance with all applicable procedures and regulations
-May perform basic microbial identification testing (eg. Gram stain) with the assistance of more experienced level microbiologist
-Assists with the collection of samples for qualification of critical utilities and operations environment in support of the Pilot Plant
The QC Analyst I will:
-Deliver compliant laboratory samples in support of clinical manufacturing and facility monitoring in accordance with appropriate regulatory, corporate and Eisai DQA procedures
-Assist with the raw materials program including sample receipt and preparation of shipments for contract test laboratory testing.
-May revise procedures as necessary to support laboratory operations with the assistance of more experienced level microbiologist or manager.
-Performs daily routine microbiological sample collection of critical utilities and environmental monitoring, and sample management within the QC Microbiology Laboratory
-Maintains the laboratory in a compliant manner by performing tasks such as cleaning of laboratory and equipment, taking inventory and ordering laboratory supplies.
-Supports raw material testing through incoming sample management and preparation of contract lab shipments
-Performs basic microbial identification testing such as gram stains
The individual will play an important role in sample collection and support for the routine operations required for microbiological support of the Biologics pilot plant. The QC Analyst I-Microbiology performs basic routine laboratory maintenance such as cleaning, inventory and ordering of laboratory supplies. QC Microbiologist I performs all laboratory procedures under the guidance of a more experienced analysts or manager
BS or MS in biological or chemical sciences or equivalent
-BS in Microbiology, or other relevant scientific discipline.
-A minimum of one (1) year of working experience in a cGMP Quality Control department in an FDA-regulated industry preferred
-Knowledge of microbiology concepts and aseptic technique used in microbiological testing.
-Ability to perform repetitive tasks while maintaining speed of work and attention to detail.
-Working knowledge of MS Office applications.
-May lift up to 30 lbs.
-May be asked to work occasional weekends during campaigns.
-Hours 7:30am – 4:30pm or 8am – 5pm
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.