Overview

We are seeking a Senior Quality Control Specialist to support the Pilot Bio-Production 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 diverse, 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.
* SEC-HPLC.
* SDS-PAGE.
* Protein by Bradford.
* PCR.
* ELISA.
* Endotoxin.
* Routine tasks:
* Environmental monitoring of production clean rooms.
* Sampling and testing of in-house purified water, WFI, and clean steam.
* Sampling and testing of the in-house compressed gas system.
* Assist the Stability Coordinator with stability coordination, protocols. and stability testing.
* Lead individual project activities as required.
* Order supplies and perform basic laboratory equipment care.
* Participate in SOP revision or authoring of new SOPs as required.
* Provide technical guidance and training for staff as required.
* Responsible for limited data review and trend analysis as requested.
* Provide all job-related progress reports or technical reports. as requested, in a timely manner.
* Maintain a safe workplace, ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
* Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
* Performs light duties and other related duties as required and assigned.

Qualifications

* An MS in a science field (preferably chemistry, biochemistry, biology, microbiology, or engineering) and 4 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 is a plus.
* Familiarity with complex scientific/office procedures and techniques relating to the position.
* Strong communication skills, including the ability to explain and teach QC methodologies.
* Ability to work independently following specific technical training.
* Must have eligibility to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. 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.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.

Employment is contingent upon successful completion of a 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.