Quality Control Specialist

USWM, LLC • Philadelphia, PA

3d

About The Position

The Quality Control Microbiology Specialist will play a critical role in ensuring the safety, quality, and compliance of drug products through the execution of microbiological testing and monitoring programs. This position is responsible for conducting in-process environmental monitoring of cGMP manufacturing suites, performing finished product safety testing including endotoxin and sterility assays, and supporting stability programs to evaluate product performance over time. The Specialist will be expected to generate accurate, reliable, and timely data while maintaining compliance with SOPs, cGMP requirements, and regulatory expectations. In addition, this role will contribute to continuous improvement initiatives, support investigations, and partner with cross-functional teams to uphold high standards of product quality and patient safety.

Requirements

• Bachelor’s degree in Molecular Biology, Biomedical Sciences, Microbiology, or a related field.
• Minimum of 2 years of experience working in a GMP-regulated quality control laboratory within the pharmaceutical or biotechnology industry.
• Previous aseptic gowning qualification and experience supporting aseptic processing environments.
• Strong working knowledge of cGMP regulations, USP, and EP testing requirements.
• Proficiency in microbiological techniques including rapid microbiology methods, endotoxin testing, growth promotion, plate reads, and environmental monitoring.
• Demonstrated ability to perform time-critical in-process and finished product testing to support manufacturing and clinical trial timelines.
• Experience conducting laboratory investigations, preparing deviations, and supporting CAPA development.
• Ability to analyze and interpret data, prepare trending reports, and contribute to test method development and SOP revisions.
• Ability to work independently on assigned projects with limited supervision.
• Strong attention to detail, organizational skills, and commitment to data integrity and compliance.

Nice To Haves

• Hands-on experience with laboratory information management systems (LIMS) and electronic data capture tools such as MODA.
• Experience collaborating cross-functionally to support batch release and regulatory submissions.
• Familiarity with continuous improvement initiatives, including updates to methods, SOPs, and workflows.

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.
• Contribute to continuous improvement initiatives, including updates to SOPs, methods, and workflows, to enhance efficiency and compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees