Quality Control Specialist

Quality Control SpecialistDepartment: Quality Reports To: Sr. Manager,QC Sterility Assurance Location: ReviveRX, Houston TX Position Type: Full-TimePosition Summary:The Quality Control (QC) Specialist is responsible for supporting critical laboratory and cleanroom operations through environmental monitoring, sample handling, and routine quality control functions. This individual plays a key role in maintaining the integrity of aseptic production environments and ensuring that all testing and documentation are carried out according to internal procedures and regulatory expectations.This role requires meticulous attention to detail, basic understanding of aseptic technique, and the ability to function independently in a fast-paced environment.Essential Duties and Responsibilities:- Perform and document daily environmental monitoring activities (surface, air, and personnel monitoring) in aseptic cleanroom environments.- Conduct temperature and humidity logging for controlled spaces using calibrated devices and electronic systems.- Gown into ISO-classified cleanrooms while maintaining aseptic technique and compliance with gowning procedures.- Perform viable/non-viable environmental monitoring and read/review microbial samples.- Follow aseptic practices and support contamination control strategies within cleanroom areas.- Prepare and handle sample submissions for laboratory analysis (e.g., sterility, endotoxin, and potency).- Assist in incubation, tracking, and logging of microbiological samples in accordance with SOPs.- Maintain cleanliness and proper handling of materials entering controlled environments, including cleaning of supplies and sample staging.- Complete and review QC documentation, logbooks, and data entry tasks with accuracy and compliance.- Utilize Microsoft Excel, Word, and related Office Suite tools to perform data entry, generate forms, and maintain documentation records.- Communicate promptly with QA and Production teams to coordinate sample transfer and testing schedules.- Understand the basics of microbial testing methods such as endotoxin, sterility, and potency and the requirements surrounding sample chain of custody.- Support inventory management of EM supplies, culture media, and reagents.- Perform other duties as assigned to support departmental goals, operational needs, and overall regulatory compliance.- Document non-compliance and work with supervisor/lead if further investigation is needed- Identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures Qualifications:Education & Experience:- Associates degree or Bachelors in Microbiology or closely related field is strongly preferred, or equivalent combination of education and experience.- A minimum of 1 year of experience in a GMP, GLP, or regulated laboratory environment (pharmaceutical, biotech, or compounding pharmacy preferred).- Familiarity with gowning and aseptic technique and cleanroom operations is strongly preferred.Knowledge, Skills & Abilities:- Basic understanding of GLP principles.- Familiarity with microbial contamination control, environmental monitoring, and aseptic gowning practices.- Strong verbal, written communication skills and computer skills are required.- Proficiency in Microsoft Excel, Word, Outlook, and basic data entry platforms.- Ability to learn and follow SOPs, regulatory guidelines, and internal protocols.- Self-motivated, dependable, and able to prioritize workload under supervision.- Comfortable working in cleanroom environments for extended periods of time.- Able to work flexible schedules and occasional weekends or holidays based on production needs. (Required)Physical Requirements:- This position is moderately active and requires standing and walking for a majority of the shift. - Must be able to lift up to 25 lbs.- Manual dexterity for handling small components and materials.Work Environment:This position operates in a controlled environment (ISO 58) and general office or laboratory spaces. Use of PPE, sterile gowning, and adherence to strict contamination control protocols is required. No makeup, perfume, fake nails, fake eyelashes, etc. PIb6b027e5cc6b-30511-37673419