US WorldMeds · 12 hours ago
Quality Control Specialist
Philadelphia, PA
Full-time
Onsite
Entry, Mid Level
2+ years expUS WorldMeds is focused on ensuring the safety and quality of drug products. The Quality Control Microbiology Specialist will conduct microbiological testing and monitoring programs, ensuring compliance with regulatory standards and contributing to continuous improvement initiatives.
Health CarePharmaceutical
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
Qualification
Required
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
Preferred
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
Company
US WorldMeds
US WorldMeds is a closely-held, Kentucky-based specialty pharmaceutical company. Our mission is to develop, license and commercialize
51-200 employees
H1B Sponsorship
US WorldMeds has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (6)
Funding
Current Stage
Growth StageTotal Funding
$15MKey Investors
National Institute on Drug Abuse (NIDA)
2016-07-01Series Unknown
2013-06-18Grant· $15M
2006-11-13Seed
Leadership Team
H Lee Warren
Chief Operating Officer
Recent News
2025-11-04
Genetic Engineering News
2025-10-28
Company data provided by crunchbase