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Rockville, Maryland, United States
Onsite
This role ensures the safety, sterility, and compliance of raw materials, in-process samples, and final products through environmental monitoring, microbial testing, and aseptic processing support. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines. The position plays a critical role in maintaining regulatory compliance and ensuring product quality for clinical and commercial manufacturing.
Role Responsibilities:
• Complete Environmental Monitoring sampling in various classification suites within the GMP Space (non-viable and viable air sampling, Surface Viable sampling).
• Ability to be gown certified for Grade D, C and B environments to support EM sampling.
• Conduct incubation and enumeration of media plates and samples.
• Processing and Sending out media plates for identification to outside testing laboratory.
• Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance.
• Assist in Routine Testing under supervision (e.g., Rapid Sterility, Mycoplasma, Bioburden, Endotoxin, Growth promotion and Cell Aliquoting) following approved methods and cGMP/GDP expectations.
• Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles.
• Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes.
• Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls.
• Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines.
Requirements:
• Associate’s degree in Biological Sciences, biology, microbiology, or related discipline with two years of experience or Bachelor’s degree with minimum three months experience.
• Experience in a pharmaceutical/biotech or related academic setting. Exposure to QC, cGMP environments, or regulated documentation is a plus.
• Experience with LIMS system (MODA, 1Lab etc..) is a plus but not a requirement.
• Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions.
• Strong focus on right-first-time execution, accurate record-keeping, and timely escalation of discrepancies.
• Demonstrates effective cross-functional collaboration, embraces flexibility in a constantly evolving environment, and maintains a positive, solutions oriented attitude to drive outcomes.
• Enthusiasm to develop new technical skills and expand responsibilities with experience.
• Ability to work on-site in a lab-based role or withing cleanroom space
• This role will support the schedule of 4/10 hour days, from Sunday thru Wednesday.
The annual base pay (or hourly rate of compensation) for this position ranges from $55,920.80 - $83,881.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
06-Nov-2026Closing Date
12-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
