QC Microbiologist I

Job Description

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QC Microbiologist I to work for a leading Orange County area biotechnology company.

Pay Rate: $29-32/hour

Summary:

Perform microbiological testing of raw materials, intermediates, API, drug product release and stability samples, as well as collection and testing of environmental monitoring samples, in accordance with cGMP requirements, company policies and procedures as directed by laboratory management. Responsibilities

Responsibilities:

• Perform routine microbiological laboratory analysis, such as Environmental Monitoring, Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic methods), operate autoclave, and prepare media in accordance with Customer, schedule and cGMP requirements.
• Read and understand test methodologies, study protocols, and Standard Operating Procedures in order to review or execute testing in compliance with necessary policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
• Work on routine tasks where analysis of situations or data requires review and evaluation of limited factors, limited judgment is required in resolving problems and making routine recommendations. Exercise judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Notify supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
• Assume ownership of assigned quality documentation, such as exceptions, change controls, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.
• Obtain and maintain aseptic gowning qualification.
• Recommend equipment, facility and process improvements to your supervisor.
• Maintain clear, accurate and traceable manufacturing records to ensure compliance with Good Documentation Practices (GDP)
• Maintain laboratory and workspace cleanliness by adhering to the 5S method of organization.
• Abide by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
• This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.

Qualifications:

• Minimum of 1-2+ years industry experience.
• Bachelor's degree or equivalent in scientific discipline required.
• Knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to aseptic manufacturing operations.
• Knowledge of aseptic manufacturing regulations, aseptic technique, clean room behaviors, and environmental monitoring operations.
• Knowledge of USP, Pharm. Eur. and other compendial methods and procedures.
• Knowledge of microbiological practices, procedures, and common analyses, such as Environmental Monitoring, Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (GelClot & Kinetic Chromogenic methods), validation - Inhibition/Enhancement Sterility Test Method Validation (Bacteriostasis/Fungistasis), and Preservative Efficacy Testing.
• Knowledge in the use of LIMS and electronic documentation systems (i.e. MasterControl).

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