Quality Control Analyst

Reviverx; Houston (TX); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

401(k) with employer match

Paid Time Off

Employee Perks & Discounts

Job summary

ReviveRX is seeking a Quality Control Analyst to support microbiological and analytical testing within a sterile compounding environment. You will perform routine microbiological assays, environmental monitoring, and data review to ensure regulatory compliance and data integrity.

The role requires prior cGMP experience, aseptic technique, and familiarity with analytical chemistry concepts. You will collaborate with QA, Production, and Facilities to maintain contamination control and timely batch

Qualifications

• Associate’s degree required in a cGMP/regulated lab setting.
• 3+ years in pharma/biotech/compounding environments.
• Experience with aseptic technique and cleanroom gowning.
• Knowledge of microbiological principles, aseptic technique, and contamination control.
• Fundamental understanding of analytical chemistry, sample prep, and lab instrumentation.
• Familiarity with cGMP/GLP documentation practices.
• Understanding of environmental and personnel monitoring programs.
• Ability to follow SOPs and regulatory requirements.
• Strong attention to detail and documentation practices.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
• Strong data interpretation and clear communication of results.
• Self-motivated with ability to manage multiple tasks in a fast-paced setting.

Responsibilities

• Perform and interpret microbiological and analytical testing including sterility, endotoxin, growth promotion, microbial id, potency, and pH.
• Operate lab instrumentation and document results per procedures.
• Perform API sampling and maintain chain of custody.
• Record and interpret biological indicator incubation results to support sterilization monitoring.
• Conduct environmental and personnel monitoring in cleanroom environments.
• Monitor temperature, humidity, and differential pressure in controlled spaces.
• Assist incubation, tracking, and documentation of microbiological samples.
• Support stability program activities and sample management for testing.
• Maintain laboratory equipment and ensure proper operation.
• Complete and review QC documentation, logbooks, and data records accurately.
• Investigate out-of-specification results, excursions, and nonconformances.
• Identify quality risks and elevate issues as needed.
• Assist in trending environmental data and contamination risk assessment.
• Support SOP/protocol/document development and adherence.
• Collaborate with QA, Production, and Facilities to support contamination control and batch release.

Skills

Aseptic technique

Documentation practices

Data interpretation

Microsoft Office

Communication skills

Multi-tasking

Attention to detail

Education

Associate’s degree in a relevant field

Bachelor’s degree in Microbiology, Biology, Chemistry, or related field

Tools

HPLC

Job description

Position Summary

The Quality Control Analyst is responsible for supporting microbiological and quality control testing activities, environmental monitoring, and cleanroom operations within a sterile compounding environment. This role executes routine microbiological testing, performs environmental and personnel monitoring, and ensures accurate documentation and data integrity in accordance with internal procedures and regulatory requirements. The QC Analyst will also support sample preparation, coordination, and data review for assays such as potency and other analytical methods. The QC Analyst is expected to demonstrate a foundational understanding of both microbiological and analytical (chemistry) testing to support overall product quality.

Key Responsibilities

• Perform and interpret microbiological and analytical testing activities, including but not limited to sterility, endotoxin, growth promotion, microbial identification, potency, and pH
• Operate laboratory instrumentation and ensure accurate interpretation and documentation of analytical test results in accordance with established procedures
• Perform raw material (API) sampling and ensure proper chain of custody for all samples
• Perform, document, and interpret biological indicator incubation results to support sterilization monitoring
• Conduct environmental and personnel monitoring (i.e., viable air, non-viable air, surface, and swab sampling) in classified cleanroom environments
• Execute temperature, humidity, and differential pressure monitoring for controlled environments
• Assist with incubation, tracking, and documentation of microbiological samples in accordance with SOPs
• Support stability program activities, including sample management and coordination of testing
• Maintain laboratory equipment and ensure proper operation
• Complete, review, and maintain QC documentation, logbooks, and data records with accuracy and compliance
• Investigate or support investigations of out-of-specification (OOS) results, environmental excursions, and nonconformances
• Identify and assess quality risks in processes and elevate issues as needed
• Assist in trending environmental monitoring data and identifying potential contamination risks
• Support development, revision, and adherence to SOPs, protocols, and quality documentation
• Collaborate with QA, Production, and Facilities to support contamination control and timely batch release
• Perform other duties as assigned to support departmental goals, operational needs, and regulatory compliance

Required Qualifications

• Associate’s degree with relevant experience in a cGMP, GLP, or regulated laboratory environment.
• 3+ years of experience in a pharmaceutical, biotech, or compounding environment
• Experience with aseptic technique and cleanroom gowning
• Working knowledge of microbiological principles, aseptic technique, and contamination control
• Foundational understanding of analytical chemistry concepts, including sample preparation, laboratory instrumentation, and interpretation of analytical data
• Familiarity with cGMP/GLP documentation practice.
• Understanding of environmental and personnel monitoring programs
• Ability to follow and execute SOPs, protocols, and regulatory requirements
• Strong attention to detail with good organization and documentation practices
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook)
• Ability to interpret data and communicate results clearly
• Self-motivated and able to manage multiple tasks in a fast-paced environment
• Strong interpersonal, verbal, and written communication skills

Preferred Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific field
• Experience with analytical chemistry methods (i.e., potency testing, HPLC, or similar)

Work Environment & Physical Requirements

• Primarily a controlled environment (ISO 5-8) and general office or laboratory spaces
• Frequent standing, walking, and use of hands
• Ability to lift up to 25 lbs
• Manual dexterity for handling small components and materials
• Use of PPE, sterile gowning, and adherence to strict contamination control protocols
• No makeup, perfume, fake or long nails, or fake eyelashes
• Schedule: Able to work flexible schedules and occasional weekends or holidays based on production needs

Featured Benefits

• Competitive salary
• Comprehensive health, dental, and vision insurance
• 401(k) with employer match
• Paid Time Off
• Employee Perks & Discounts

Equal Employment Opportunity (EEO) and Affiantious Action Commitment

ReviveRX is committed to providing equal employment opportunities and render affirmative action to all employees and applicants for employment, including individuals who are members of underrepresented groups, without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other status protected by applicable federal, state, or local laws.

Reasonable Accommodations Statement

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.