CAMRIS International 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 Assurance Assistant for Vaccine Production to support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
* Provides comprehensive quality support to the Pilot Bioproduction Facility (PBF) and the QA Manager in accordance with Good Manufacturing Practices (GMPs).
* Assists in making continual improvements to the Pilot Bioproduction Facility (PBF) quality systems to execute and implement current Good Manufacturing Practices and to increase system efficiency as directed by QA Manager. Report compliance deficiencies to QA Manager and other PBF managers as required.
* Interacts with other PBF and government personnel for the purpose of successfully producing vaccines and other biological materials.
* Learns and maintains understanding of and training in the use of the PBF quality and documentation systems. Follows existing Standard Operating Procedures (SOPs).
* Follows current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations as they apply to all levels of work.
* Acts as “second in command” to the QA Manager in their absence and/or when designated. Assists the QA Manager in directing and managing the QA documentation and inventory areas.
* Assists in monitoring/directing the calibration/validation contractor.
* Assists QA Manager in designing and implementing various aspects of the PBF quality systems.
* Provides guidance and training to PBF staff regarding cGMPs and quality systems.
* Tracks and trends data as assigned by QA Manager.
* Prepares/writes various cGMP documents (SOPs, Batch Records, Forms, investigations, reports, audits, etc.)
* Reviews and evaluates all types of draft and completed cGMP documents.
* Provides service to other QA staff, PBF managers and other production personnel, CRADA partners, and Primary Investigators (PIs) as needed/directed.
* Assists in the procurement and supply of regulatory information for IND submissions and other needs as directed by the QA Manager.
* Assists QA Manager during regulatory/customer audits and assists in preparing responses and implementing corrective/preventive actions.
* Performs failure investigations, internal/external audits and other more involved QA actions as directed by the QA Manager.
* Serves as a backup to other QA staff members as needed.
* Provides assistance to PIs/CRADA partners as required/requested.
* Provides other administrative support as directed by the QA Manager.
* Maintains a safe workplace; be aware of and observe appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to the position.
* Serves as an emergency responder in the event of freezer/refrigerator failure in order to protect inventory at risk.
* Must have at least a BS/BA in biology or other life science field. An MS or better is a plus.
* Must have been employed for a minimum of 6 years at a cGMP biotechnology, pharmaceutical, or related facility with at least 4 years of experience in QA.
* Must have at least intermediate skills in Word and Microsoft Excel, along with good grammar, spelling and proofreading skills and attention to detail. Skills in Microsoft Access and LIMS systems a definite plus.
* Must be able to work independently and with significant initiative. Some nights or weekends may be required.
* Aseptic gowning and entering cleanrooms may be required.
* Must be able to follow directions and written policies and procedures for all work responsibilities.
* Must have good people and communication skills (written and verbal).
* RAC Certification a plus.
CAMRIS International offers competitive salaries and comprehensive benefits. Please submit your resume online at https://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, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.