Quality Control (QC) Environmental Monitoring (EM) Specialist

Overview

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 are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.

CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• Execute analytical and microbiological testing on in-process materials and finished vaccine products, including (but not limited to):
• 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.
  

Qualifications

• 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.
  
  

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements

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.

Physical Demands

• 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.
  
  

Physical Activities

• 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 accuracy, neatness, and thoroughness of the work assigned.
  
  

Environmental Conditions

• Constantly work in environments where no adverse environmental conditions are expected.
  
  

PPE and Chemical Requirements

• Constantly wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Constantly wear a lab coat.
• Occasionally wear earplugs/muffs.
• Constantly wear a Clean Room Uniform.
• Occasionally wear a disposable dust/surgical mask.
• Occasionally come in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust, and powders, etc.
  
  

Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.