We are currently searching for a QC Manager, Microbiology to provide support a highly productive Microbiology Lab within the National Institutes of Health (NIH). This opportunity is a permanent, full-time position with MSC and it is on-site in Bethesda, Maryland.
The QC Manager, Microbiology will be responsible for the daily technical management, oversight, and maintenance of the Sterility Testing Quality Control Program to ensure compliance with regulatory guidelines for testing provided for manufacturing and testing facilities on the NIH campus.
Duties and Responsibilities:
Oversee and manage the daily testing of sterility testing products and environmental monitoring cultures in accordance with regulatory guidelines including 21 CFR 610.12, USP, USP, USP, USP, USP, and ANSI/AAMI 13959:2014.
Design, perform, and write formal documentation for suitability/validation testing (bacteriostasis, fungistatis, Mycoplasma) of new products submitted for sterility testing.
Audit documentation of testing operations to ensure that test methods and results meet current CFR, USP, and AAMI, requirements concerning safety and quality assurance specifications.
Certify laboratory compliance for testing methods relating to specifications of components such as equipment, facilities, environment, media, and personnel competency.
Review result records of sterility testing and environmental monitoring in real-time to determine compliance within recommended acceptable and actionable thresholds, and to identify errors. If errors have occurred internally, initiate investigation to ensure appropriate corrective action is taken.
Notify submitting facilities of positive results and assist in coordinating active follow-up investigations to identify the source of contamination.
Maintain an organized electronic systems for quality control documents and records including SOPs, calibration records, growth promotion records, temperature records, equipment logs, cleaning logs, validation records, instrument and equipment maintenance, and personnel training and competency assessments.
Maintain inventory and tracking of testing supplies and arrange contracts for purchase of supplies and maintenance of equipment.
Maintain up-to-date knowledge of regulatory guidelines (CFR, USP, AAMI).
Ensure quality control and assurance records are readily available in manufacturing facilities upon request, and for inspections by safety and auditing/regulatory agencies.
Establish and provide a QC training and competency testing program to ensure personnel are knowledgeable and compliant with sterility testing and environmental monitoring testing procedures.
Write SOPs for validations and testing of products and environmental cultures.
Ph.D. in Biological Sciences.
Strong knowledge base on the clinical relevance of organisms, understanding of microbiological test systems, organism identification acceptability criteria, as well as critical analysis of results.
Must be able to provide microbiological expertise (consultation and on the bench) with little additional training.
Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.
...We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!