QC Data Reviewer ; mic)

We believe a comprehensive benefits package is not just important — it’s essential for your well-being and success.

ARL Bio Pharma is the leading pharmaceutical testing Company in the country with a well-earned reputation for premium customer service and quality science.

The Microbiology Data Reviewer I, will perform routine review of microbiological testing results, at times supporting verification activities in accordance with established protocols, Standard Operating Procedures (SOPs), and Work Instructions (WIs). This position will address increasingly complex tasks and demonstrate proficiency in Microbiology through the quality review and approval of test results, ensuring compliance with approved methodologies and data interpretation requirements.

This role is responsible for reviewing data generated from microbiological testing including Sterility Testing, Bacterial Endotoxin Testing, Rapid Sterility testing (ScanRDI and Celsis), Method Suitability, Antimicrobial Effectiveness Testing, Microbial Enumeration, Absence Testing, Growth Promotion, Quality Control (QC) testing, and other Microbiology Department activities as assigned.

Work Restrictions: Because of the vital and exacting nature of our work and federal regulations, we do not allow medical marijuana cards, and we do random drug testing on all our employees.

• 100% Company-paid Medical, Dental and Vision Insurance
• Matching 401K Retirement Contributions
• Free Lunch Daily
• Opportunities afforded by an organically growing company
• Generous paid time off
• Opportunity to work with amazing people and play a key role in making America safer

Work Schedule:

Normal hours of operation are Monday through Friday, 08:00 a.m. to 05:00 p.m.
Days and Hours of Work vary by assigned tasks, depending on business needs. The schedule will be discussed with the supervisor to address the company's and department's needs. Some Flexibility is required as occasional extensions outside the normal schedule and weekends may be necessary to meet business needs.

• Maintain data review activities in compliance with departmental Standard Operating Procedures (SOPs), safety requirements, industry standards, and applicable federal regulations.
• Strict adherence to Standard Laboratory Operations and Quality Management Systems (QMS).
• May learn and perform various microbiology tests including sterility, fungal, endotoxin identification, and to assess growth media.
• May learn and perform filtration to perform Sterility testing for quality control for clients.
• May learn and perform different Growth Media specifically to the goal of the test being performed to identify and screen specific organisms that would be particularly dangerous for each product and or dosage form.
• May learn and perform techniques such as gram stain reaction, morphology, and metabolic reaction to isolate microorganisms for accurate identification and testing, to determine causes of contamination in clients' samples.
• Review detailed microbiological testing data for QMS, federal, and industry compliance, including but not limited to Sterility, Bacterial Endotoxin, Rapid Sterility (ScanRDI and Celsis), Method Suitability, Antimicrobial Effectiveness, Microbial Enumeration, Absence Testing, Growth Promotion, and QC testing, reporting any errors, discrepancies, or deviations to leadership.
• Perform data review utilizing knowledge of microbiological principles, internal and external guidelines, approved test methods, and laboratory systems including LIMS and rapid microbiological platforms.
• Maintain a professional laboratory and office environment by keeping work areas, desks, and shared spaces clean, organized, and compliant with laboratory standards.
• Assist with documentation and reporting needs as directed by…