Quality Control Associate

Job Description: Quality Control Associate Overview:

The Quality Control (QC) Associate plays a critical role in supporting microbiology laboratory operations under general supervision. This position involves performing routine microbiological testing, data documentation, and compliance with safety and regulatory guidelines. Key Responsibilities:

Conduct routine microbiological laboratory procedures, including bioburden and microbial count testing, biological indicator testing, growth promotion testing, and media inspections. Analyze environmental monitoring samples and ensure compliance with standard operating procedures (SOPs). Document, compute, and enter data in Laboratory Information Management Systems (LIMS) or SmartLab (LMES) with accuracy. Maintain specialized laboratory equipment and ensure preventive maintenance is performed on schedule.

Participate in investigations of out-of-specification results and support internal and external audits. Support lab organization and cleanliness, including archiving documentation and preliminary plate readings. Collaborate with team members to implement lab improvements and troubleshoot issues as they arise.

Maintain adherence to safety guidelines, cGMPs, and other regulatory requirements. Qualifications Basic: Bachelor’s degree in a relevant scientific discipline with one year of related experience; or an equivalent combination of education and experience.

Associate degree with six years of relevant experience; or a high school diploma/GED with eight years of related experience. Preferred: Experience with GxP practices in biopharmaceutical testing and familiarity with QC systems such as CDOCS (Veeva Vault), LIMS, and SmartLab. Knowledge of data integrity requirements in QC processes.

Proficiency in Microsoft Office and excellent problem-solving capabilities. Skills: Strong written and oral communication skills. Detail-oriented with the ability to manage multiple priorities and meet deadlines.

Flexibility and adaptability to changing requirements. Understanding of regulatory compliance and safety guidelines. Physical Requirements:

Ability to perform tasks requiring personal protective equipment and to lift/carry objects up to 15 pounds. Frequent tasks include fine hand manipulation and desk-based computer work. Working Conditions: On-site work schedule of Monday to Friday, with potential weekend and holiday shifts based on operational needs.