GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
The Microbiologist II will be responsible to perform high throughput laboratory work to meet production schedules and project milestones. They are expected to follow procedures and have familiarity and proficiency with a wide variety of microbiological methods and supporting data management processes. Microbiological disciplines common to the laboratory include, but are not limited to:
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Environmental monitoring of cGMP controlled areas.
• Total particulate count monitoring of controlled areas.
• Sampling and testing of pharmaceutical grade water.
• Microbial identifications.
• Growth promotion.
• Microbial Enumeration Testing (Bioburden),
• Bacterial Endotoxin Testing (kinetic chromogenic, gel clot)
• Biological Indicator enumeration testing
• Sterility testing.
• Gown qualification.
• Accurate and thorough documentation.
• Proficiently perform all qualified testing methods used by the Microbiology department.
• Responsible for a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills, disciplines, and procedures within assigned discipline area(s)
• Support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution and data review.
• May provide technical services (such as preparing reports and initiating deviations) from preexisting templates.
• Trainer within areas of proficiency
It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Must possess excellent communication (oral and written), organizational, and interpersonal skills.
• Detail oriented with strong aseptic techniques and documentation skills.
• Ability to follow SOPs and cGMP guidelines and regulations is required.
• Must be able to work in a team environment and perform job responsibilities under minimal supervision.
• Must be proficient with MS Office applications.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• Associate’s degree in microbiology, biology, or other relevant scientific discipline and 3-6 years of related lab experience; or equivalent combination of education and experience.
• Bachelor’s degree preferred.
• Must possess proven understanding of SOPs and cGMP guidelines and regulations. Aseptic gowning certification desired.
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.
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