Quality Control Specialist

The Quality Control Specialist plays a vital role in maintaining the integrity and compliance of aseptic cleanroom and laboratory operations within a regulated pharmaceutical compounding environment. This position is responsible for performing and documenting environmental monitoring activities, supporting microbiological sample handling and testing, and ensuring that all quality control functions are carried out in accordance with cGMP/GLP standards, internal SOPs, and applicable regulatory requirements. The ideal candidate brings hands-on experience with aseptic technique, cleanroom operations, and quality documentation, and demonstrates a strong commitment to accuracy, contamination control, and operational excellence. This role requires the ability to work independently in a fast-paced environment while maintaining a meticulous attention to detail and a proactive approach to identifying and mitigating quality risks.

• →Perform and document daily environmental monitoring activities (surface, air, and personnel monitoring) in aseptic cleanroom environments
• →Conduct temperature, humidity, and differential pressure 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 cleanroom release inspections prior to compounding to ensure compliance with environmental and operational requirements
• →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)
• →Perform raw material (API) sampling and prepare for laboratory analysis
• →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
• →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 laboratory and environmental monitoring supplies, culture media, and reagents
• →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 
• →Perform other duties as assigned to support departmental goals, operational needs, and overall regulatory compliance

• Associate’s degree in Microbiology, or closely related field is strongly preferred, or equivalent combination of education and experience.
• 1+ year of experience in a cGMP, GLP, or regulated laboratory environment
• Experience performing cleanroom gowning and aseptic technique in a controlled environment
• Basic understanding of cGMP/GLP principles
• Familiarity with microbial contamination control, environmental/personnel monitoring, and aseptic gowning practices
• Strong verbal, written communication skills and computer skills
• 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

• Bachelor’s degree in Microbiology, or closely related field
• 1+ year of experience in a pharmaceutical, biotech, or compounding pharmacy

• 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