QC Data Reviewer I (mic)

ARL Bio Pharma•Oklahoma City, OK

2d•Onsite

About The Position

ARL Bio Pharma is seeking a Microbiology Data Reviewer I to perform routine review of microbiological testing results and, at times, support verification activities in accordance with established protocols, Standard Operating Procedures (SOPs), and Work Instructions (WIs). The role handles increasingly complex tasks and applies microbiology knowledge to review and approve test results, ensuring compliance with approved methodologies and data interpretation requirements. The reviewer examines data 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, QC testing, and other assigned Microbiology Department activities. The position uses laboratory and quality systems, including LIMS and rapid microbiological platforms, and works with laboratory analysts, supervisors, quality personnel, and cross-functional teams. Normal operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m., but days and hours vary according to assigned tasks and business needs. Occasional extensions beyond the normal schedule and weekend work may be necessary. Office attendance is required. Routine duties are performed outside controlled laboratory spaces, though occasional movement to laboratory-adjacent areas is required. The role operates in a professional laboratory environment and may involve exposure to chemicals and other environmental conditions, use of PPE, and occasional use of a respirator or cleanroom suit.

Requirements

Bachelor’s degree in Microbiology or equivalent diploma.
One year of experience in a microbiology laboratory setting performing detailed microbiology tests.
Understanding of microbiological testing principles, data integrity requirements, quality systems, and regulatory expectations applicable to microbiology laboratory testing.
Ability to review and interpret test results and supporting documentation.
Ability to operate and review data from microbiological laboratory systems and instrumentation, including LIMS and rapid microbiological methods platforms such as ScanRDI and Celsis.
Ability to identify, evaluate, and resolve data discrepancies, documentation errors, and compliance issues according to approved procedures and escalation pathways.
Ability to manage multiple review tasks, maintain accurate records, meet timelines, and prioritize work.
Strong attention to detail when reviewing data, calculations, documentation, and reports.
Ability to collaborate with analysts, supervisors, quality personnel, and cross-functional teams.
Effective time management for time-sensitive review activities and reporting deadlines.
Professional verbal and written communication, including interaction in person, by email, and by telephone with internal and external parties.
Digital literacy, including use of MS Office and electronic systems such as LIMS, quality management systems, electronic laboratory notebooks, document-control platforms, and client-facing reporting tools.
Intercultural sensitivity when working with people from diverse backgrounds and experiences.
Fluency in written and spoken English to receive and communicate information clearly and accurately.
Ability to attend the office.

Responsibilities

Maintain data review activities in compliance with departmental SOPs, safety requirements, industry standards, and applicable federal regulations.
Adhere to Standard Laboratory Operations and Quality Management Systems (QMS).
Learn and perform various microbiology tests, which may include sterility, fungal, endotoxin identification, and growth-media assessment.
Learn and perform filtration for client quality-control Sterility testing.
Learn and perform growth-media procedures intended to identify and screen for organisms relevant to a product or dosage form.
Learn and perform techniques such as Gram stain reaction, morphology, and metabolic reaction to isolate microorganisms for identification and testing and help determine causes of sample contamination.
Review detailed microbiological testing data for QMS, federal, and industry compliance, including data from Sterility, Bacterial Endotoxin, Rapid Sterility (ScanRDI and Celsis), Method Suitability, Antimicrobial Effectiveness, Microbial Enumeration, Absence Testing, Growth Promotion, and QC testing.
Report errors, discrepancies, or deviations to leadership.
Review data using microbiological principles, internal and external guidelines, approved test methods, and laboratory systems, including LIMS and rapid microbiological platforms.
Keep work areas, desks, and shared spaces clean, organized, and compliant with laboratory standards.
Assist with documentation and reporting as directed by appropriate personnel.
Properly use and maintain required PPE and laboratory safety equipment, and identify and report potential hazards promptly.
Complete required safety and compliance training, including OSHA, departmental SOPs, and company-mandated training programs.