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 Senior Quality Assurance (QA) Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
- Provide quality assurance support for Viral Vaccines and Viral Diagnostics and Analytical Development (VDAD) departments. This includes assistance with creating, revising, and reviewing SOPs, forms, and Master Production Records (MPRs); review of executed batch records and
- VDAD testing records; production and review of labels; issuance of logbooks; creation of certificates of analysis; reviewing and resolution of deviations, failure investigations, critical change documentation; providing GMP guidance; assistance with internal and external audits and inspections of dengue products.
- Provide regulatory support for dengue products by providing copies of appropriate records (MPRs, batch records, stability protocols, test data, label formats, etc.) and developing I reviewing narratives, flow charts, data tables, etc. that will be used in submissions to the FDA (Pre-INDs, INDs, IND Amendments, Study Procedures Manuals, Investigator's Brochures, etc.)
- As required, design and oversee post-production packing and labeling of dengue products to create dosing kits for clinical trials.
- Oversee the PBF's calibration program, including working with the subcontractor to schedule calibration; review and approve executed calibration records; initiating out-of-tolerance reports, as required; and inputting data into the QA calibration database.
- Provide back-up support to Department Chief and QA Manager as needed. Serve as Acting QA Manager as required.
- Interact with the building monitoring system to ensure equipment remains in a proper state of operation.
- Provide back-up quality assurance support for other product areas (Fermentation, Purification, Fill/Finish) as needed, including creating, revising and reviewing SOP, forms MPRs; review of executed batch records; production and review of labels; issuance of logbooks; creation of certificates of analysis; review and resolution of deviations, failure investigations, critical change documentation; and providing GMP guidance.
- Participate in the continuous improvements to the PBF and quality systems to execute and implement current good manufacturing practice (cGMP) and to increase system efficiency; report compliance deficiencies to the QA Manager and/or other Section Heads, or PBF Management as appropriate; maintain updated quality and safety training.
- 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.
- Back-up other QA staff members as needed and perform light duties and other related duties as required and assigned.
- A bachelor's degree and 10 years of relevant experience, or an equivalent combination of education and experience.
- A full understanding of QA from a Biotechnology, Pharmaceutical or related facility and GMP and regulatory training. Must be familiar with Microsoft Office.
- Knowledge of applicable highly complex office procedures and techniques relating to position.
- Work Environment: office environment; may require working evenings and weekends.
- Ability to work independently following a brief period of 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.