QC Data Reviewer I (mic)

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. Key Benefits: 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.

Key Duties: 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 appropriate personnel. Adhere to, properly use, and maintain required Personal Protective Equipment (PPE) and laboratory safety equipment, and promptly identify and report potential hazards. Complete all required safety and compliance training, including but not limited to OSHA, departmental SOPs, and company-mandated training programs Key Skills, Abilities & Success Factors: Technical Capacity: This position must understand microbiological testing principles, data integrity requirements, quality systems, and regulatory expectations applicable to microbiology laboratory testing, including the review and interpretation of test results and supporting documentation.

Knowledge of Mechanical & Computerized Tools: This position will operate and review data generated from microbiological laboratory systems and instrumentation, including Laboratory Information Management Systems (LIMS), rapid microbiological methods platforms (e.g., ScanRDI and Celsis), and other computerized laboratory and quality systems.

Problem-Solving: This position will independently and collaboratively identify, evaluate, and resolve data discrepancies, documentation errors, and compliance issues in accordance with approved procedures and escalation pathways. Organizational Ability: This position will manage multiple data review tasks simultaneously while maintaining accurate records, meeting established timelines, and prioritizing work to support laboratory operations and client deliverables.

Detail Proficiency: This position will demonstrate a high level of attention to detail when reviewing microbiological data, calculations, documentation, and reports to ensure accuracy, completeness, and regulatory compliance. Collaboration Proficiency: This position will work effectively with laboratory analysts, supervisors, quality personnel, and cross-functional teams to support accurate data review, issue resolution, and continuous improvement initiatives.

Time Management: This position deals with time-sensitive data review activities and must effectively balance routine and project-based workloads to meet testing schedules and reporting deadlines. Professional Verbal and Written Communication: This position interacts in person and by email, and by telephone with external and internal agencies and must demonstrate a professional manner reflecting the company image.

Digital Literacy: This position uses MS Office applications and multiple external and internal web-based and electronic systems and databases such as Laboratory Information Management Systems (LIMS), quality management systems, electronic laboratory notebooks (ELN), document control platforms, and client-facing reporting tools.

Intercultural Sensitivity: This position will work with diverse populations of characteristics and must demonstrate recognition of the value of diverse backgrounds, experiences, and abilities.

Minimum Qualifications

Bachelor’s degree in Microbiology or equivalent Diploma with 1 year of experience in a microbiology laboratory setting.performing detailed microbiology tests. Work Environment: The administrative area may be located in close proximity to laboratory operations; however, routine job duties are performed outside of controlled laboratory spaces.

Occasional movement between office areas and laboratory-adjacent spaces may be required to support departmental communication and workflow This job operates in a professional Laboratory environment using typical protection equipment (Eye protection, Gloves, Lab Coats, etc.) as well as at times respirator and/or Cleanroom suit as appropriate.

This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

Essential duties

of laboratory environment with periodic exposure to chemicals, solvents, and other environmental substances and conditions including but not limited to odors, and varying temperatures. Exposure to the use of chemicals with the classification of Hazardous, Toxic, Corrosive, Flammable, or Oxidizing. The noise level is moderate.

Primarily dominated English-speaking workplace. Attendance at the office is required. Primarily dominated English-speaking workplace. Physical Requirements: This is an active role with occasional walking between buildings daily some filing is required. Ability to sit and stand in front of a computer for extended periods, with intermittent twisting/bending to reach workstation or supplies surrounding workstation.

This position would require the ability to lift 50 Lbs. (if an object weighs more than 50 Lbs. ARL requires this to be a two-person job or use of carts). Ability to use hand strength and finger dexterity to perform manipulations such as typing. Must be able to wear Personal Protective Equipment (PPE). Must be fluent in written and spoken English to receive and communicate information for standard and complex operations and emergencies clearly and accurately.

Requires visual acuity to read and write words and numbers and to see in the normal visual range including ability to distinguish colors and shapes with or without correction. Requires hearing communications accurately with or without correction. May require the ability to use a full-face respirator kit for extended hours as required.

May require the ability to wear a full Clean Room Suit as directed by supervisor. AAP/EEO Statement ARL Bio Pharma, Inc. provides equal employment opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law.

ARL Bio Pharma, Inc. expressly prohibits any form of workplace harassment based on race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. Improper interference with the ability of ARL Bio Pharma, Inc.

employees to perform their job duties may result in discipline up to and including discharge. Further, the company takes affirmative action to ensure that applicants and employees are treated without regard to any of these characteristics.