Quality Control Microbiology Associate The Quality Control Microbiology Associate will support the safety, quality, and compliance of drug products through the execution of routine microbiological testing and monitoring activities. This position is responsible for performing in-process environmental monitoring of cGMP manufacturing suites, conducting finished product safety testing including endotoxin and sterility assays, and assisting with stability program testing to evaluate product performance over time. The Associate will be expected to generate accurate and timely data while following SOPs, cGMP requirements, and regulatory guidelines. In addition, this role will support laboratory operations, assist with investigations and documentation activities, and collaborate with cross-functional teams to maintain high standards of product quality and patient safety.
Duties and Responsibilities:
Perform in-process environmental monitoring of classified cGMP manufacturing suites, including routine viable and non-viable particulate testing.
Execute finished product microbiological assays such as endotoxin and sterility testing in accordance with compendial methods and internal SOPs.
Conduct stability testing to assess product quality and integrity throughout the product lifecycle.
Ensure all laboratory activities are performed in compliance with cGMP, FDA, and other applicable regulatory requirements.
Accurately document, analyze, and report test results in a timely manner while maintaining data integrity standards.
Participate in investigations related to environmental monitoring excursions, out-of-specification (OOS) results, or deviations, and support implementation of corrective and preventive actions (CAPA).Collaborate with cross-functional partners in Manufacturing, Quality Assurance, and Technical Operations to support batch release and regulatory submissions.
Maintain laboratory equipment, supplies, and aseptic practices to ensure a safe, compliant, and efficient work environment.
Qualifications:
Bachelor's or Associates degree in Molecular Biology, Biomedical Sciences, Microbiology, or a related field.0-3 years of experience working in a GMP-regulated quality control laboratory within the pharmaceutical or biotechnology industry.
Novice working knowledge of cGMP regulations, USP, and EP testing requirements.
Knowledge of microbiological techniques including rapid microbiology methods, endotoxin testing, growth promotion, plate reads, and environmental monitoring.
Ability to perform or learn time-critical in-process and finished product testing to support manufacturing and clinical trial timelines.
Ability to analyze and interpret data, prepare trending reports, and contribute to test method development and SOP revisions.
Strong attention to detail, organizational skills, and commitment to data integrity and compliance.
Desirable:
Hands-on experience with laboratory information management systems (LIMS) and electronic data capture tools such as MODA.Previous Gown Qualification for aseptic processing experience.
Familiarity with continuous improvement initiatives, including updates to methods, SOPs, and workflows.
Experience conducting laboratory investigations, preparing deviations, and supporting CAPA development.
Ability to work independently on assigned projects with limited supervision.
Limited knowledge and experience with EM plate reads, growth promotion as well as endotoxin and sterility testing.
Physical Demands:- Frequently required to stand
- Frequently required to walk.
- Frequently required to sit.
- Frequently required to talk or hear.
- Occasionally required to lift light weights (less than 50 pounds)
- Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus
Work Environment: The noise level in the work environment usually is quiet.
