Quality Control; QC Environmental Monitoring; EM Specialist

Job Description

We are seeking a Quality Control (QC) Environmental Monitoring (EM) Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP‑compliant pharmaceutical manufacturing facility engaging in next‑generation development for cutting‑edge companies and government agencies. The professionals at PBF engage in trailblazing endeavors every day. The end products vary, so each year brings multiple opportunities for professional enrichment in original projects.

• Execute analytical and microbiological testing on in‑process materials and finished vaccine products, including:
• Growth media growth promotion.
• Microbial seed viability.
• Microbial identification.
• Gram Stain.
• Protein concentration.
• Visual Inspection.
• Routine tasks:
• Environmental monitoring of production clean rooms.
• Sampling and testing the in‑house purified water (WFI) and clean steam.
• Sampling and testing of the in‑house compressed gas system.
• Assist senior associates on lab projects as requested and work on specialty projects as assigned.
• Order supplies and perform basic laboratory equipment care.
• Participate in SOP revision or authoring of new SOPs as required.
• Responsible for limited data review and trend analysis as requested.
• Train staff as requested.
• Provide all job‑related progress reports or technical reports, as requested, in a timely manner.
• Maintain a safe workplace, ensuring that they know and observe appropriate safety and occupational health rules and regulations.
• The employee must attend safety training relative to their position and report any infractions of safety procedures to the facility Safety Officer.
• Performs other duties as assigned.

• BA/BS degree in a science field (preferably chemistry, biochemistry, biology, microbiology, or engineering) and four years of experience in a regulated laboratory environment or an equivalent combination of credentials and experience.
• Skills in using various types of analytical techniques and laboratory equipment.
• Excellent computer skills, including Microsoft Office software such as Word and Excel. Experience with technical writing and LIMS is a plus.
• Knowledge of aseptic technique, cGMP, cGLP, or FDA regulations a plus.
• Required Knowledge, Skills, and Abilities:
  Knowledge of complex scientific/office procedures and techniques relating to the position.
• Strong communication skills, including the ability to explain and teach methodologies.
• Ability to work independently following specific technical training.
• Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non‑US citizen.

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Constantly conduct light work that includes moving objects up to 20 pounds.
• Occasionally conduct medium work that includes moving objects up to 50 pounds.
• Occasionally push or pull less than 25 pounds, and push or pull 25–45 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Constantly stand or walk for more than 25 minutes.
• Occasionally bend, reach, or twist repeatedly.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

• Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
• Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the…