QA/QC Microbiologist
$56.71k - $84.22kPrecise Systems (MD)
Job Description Precise Systems delivers integrated, mission-ready solutions that advance warfighter readiness and strengthen our nation's most critical defense programs. Through the power of our combined capabilities, we provide deep expertise in Advanced Engineering; Digital Transformation; Electromagnetic Warfare; Interactive Training & Simulation; Physical Sciences Research; Platform Lifecycle Support; and Foreign Military Sales. Unified by decades of trusted performance and expanded through strategic growth, our team applies innovative technologies, engineering rigor, and customer-focused execution to solve complex challenges and accelerate mission success. Guided by our commitment to partnership, precision, and performance, we deliver the scalable solutions and technical excellence our customers depend on-today and into the future. The Microbiologist supports a biology laboratory that validates, characterizes, and optimizes bacterial strains used to produce target molecules, including proteins and antibodies. The incumbent performs microbiological testing, bench-scale production support, biolayer interferometry (BLI), antibody verification, and conformance testing within an ISO-accredited quality assurance/quality control (QA/QC) program. The position generates complete, accurate, and traceable technical data supporting strain performance, product quality, assay performance, and conformance determinations. The incumbent will be trained to package and ship biological materials in accordance with applicable organizational procedures and transportation requirements. This role requires in person support Duties: Microbiology and Production Support
- Culture, maintain, characterize, and preserve bacterial strains used in protein, antibody, and other target-molecule production activities.
- Conduct strain-validation studies to assess identity, purity, viability, growth characteristics, stability, and production performance.
- Support bacterial culture and bench-scale fermentation activities, including preparation, monitoring, sampling, and documentation of assigned runs.
- Assist with optimization studies evaluating media composition, inoculation conditions, temperature, pH, agitation, aeration, harvest timing, and other approved process parameters.
- Prepare culture media, buffers, reagents, standards, controls, and test materials in accordance with approved procedures.
- Collect, process, label, store, and track samples while maintaining required sample integrity and traceability.
- Identify and report evidence of contamination, atypical culture behavior, equipment malfunction, test deviations, or other conditions that could affect data integrity or product quality.
- Perform BLI assays using approved methods to support antibody verification, characterization, and conformance testing.
- Prepare assay plates, biosensors, controls, standards, samples, and reagents required for BLI testing.
- Generate and review BLI data, including assay controls, binding-response data, and defined reportable results.
- Perform antibody verification and conformance testing using approved test methods, reference materials, and acceptance criteria.
- Evaluate antibody identity, binding performance, specificity, concentration, activity, or other defined quality attributes, as applicable to approved laboratory methods.
- Document test conditions, calculations, results, observations, and conclusions in controlled laboratory records.
- Assist with troubleshooting assay failures, atypical results, invalid runs, out-of-specification results, and out-of-trend results under supervisory direction.
- Maintain appropriate handling, storage, lot traceability, and expiration control for antibodies, standards, controls, biosensors, and related test materials.
- Perform work in accordance with the laboratory's ISO-accredited QA/QC program, approved standard operating procedures, test methods, safety requirements, and records-control practices.
- Maintain complete, contemporaneous, accurate, and traceable laboratory documentation in approved paper or electronic systems.
- Follow established procedures for sample receipt, testing, data review, deviation reporting, equipment use, reagent control, and records retention.
- Support test-method verification, equipment qualification, calibration checks, preventive maintenance, and performance verification activities.
- Assist with preparation and revision of standard operating procedures, worksheets, test records, protocols, and technical reports.
- Participate in quality reviews, internal audits, corrective-action activities, root-cause investigations, and continuous-improvement efforts, as assigned.
- Maintain laboratory inventory and verify appropriate storage, labeling, expiration dating, and availability of laboratory supplies and controlled materials.
- Bachelor's degree in microbiology, biology, biotechnology, biochemistry, immunology, molecular biology, or a closely related scientific discipline.
- At least 3 years' experience performing the duties above
- Laboratory experience gained through employment, internships, research, coursework, or equivalent practical training.
- Knowledge of aseptic technique, bacterial culture, culture-media preparation, and basic microbiological testing methods.
- Familiarity with laboratory documentation, data recording, and use of controlled procedures.
- Ability to perform detailed laboratory work accurately and consistently.
- Ability to organize technical data, perform routine calculations, and communicate results clearly.
- Ability to work effectively as part of a laboratory and QA/QC team.
- Ability to complete and maintain required biological-material shipping training.
- Experience performing BLI assays or other antibody-binding, affinity, or immunoassay methods.
- Experience with antibody verification, antibody characterization, protein testing, or conformance testing.
- Experience in a regulated, accredited, or quality-managed laboratory environment.
- Familiarity with ISO quality-system principles, controlled documents, data integrity, traceability, deviations, corrective actions, or audit support.
- Experience with bacterial fermentation, bench-scale bioreactors, recombinant protein expression, or microbial production systems.
- Experience with laboratory information-management systems, electronic laboratory notebooks, or spreadsheet-based technical analysis.
Vacancy posted 9 hours ago
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