What are the responsibilities and job description for the Quality Control Scientist position at CAMRIS?
Overview
CAMRIS International, LLC is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.
We are seeking a Quality Control Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
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 concentration.
- Perform routine tasks:
- Environmental monitoring of production cleanrooms.
- Sampling and testing of in-house purified water, WFI, and clean steam.
- Sampling and testing of in-house compressed gas system.
- Conduct or participate in special or technically demanding projects.
- Provide technical guidance and training for staff as required.
- Support PBF’s Operational Excellence Strategy by building out/improving processes, systems, and tools.
- Author or participate in the revising of new SOPs or forms as required.
- Roll out weekly QC meeting (side structure).
- Responsible for data review and trend analysis as requested.
- Support coordination of QC schedules as necessary.
- Provide all job-related progress reports or technical reports as requested, in a timely manner.
- Order supplies and perform basic laboratory equipment care and maintain the adequacy of inventory.
- Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
- Attend safety training relative to the 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
- A master’s degree in a science field (preferably chemistry, biochemistry, biology, microbiology, or engineering) and 10 years of relevant experience, or an equivalent combination of credentials and experience.
- Skills in using various types of analytical techniques and laboratory equipment.
- Knowledge of ICH and USP guidelines.
- Excellent computer skills, including Microsoft Office software such as Word and Excel. Experience with technical writing and LIMS a plus.
- Understanding of operational excellence/lean principles and applications.
- 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.
- Must be able to work independently following specific technical training.
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.