Senior Quality Assurance Specialist – On the Floor

We seek a Quality Assurance (QA) Specialist On the Floor to support the Walter Reed Army Institute of Researchs Pilot Bioproduction Facility (PBF). This role ensures that early-phase (Phase I/II) clinical pilot-scale and process development manufacturing activities comply with current Good Manufacturing Practices (cGMP) internal procedures and regulatory requirements.

This position operates in a dynamic environment where processes may be evolving and scale-up activities are ongoing. The QA Specialist serves as a critical partner to Manufacturing Process Development Quality Control and Engineering teams by actively monitoring operations on the production floor identifying risks and ensuring quality and compliance standards are upheld while enabling agility and innovation.

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 todays 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.

• Provide direct QA support during pilot-scale manufacturing operations including process development technology transfer scale-up and clinical production activities.
• Perform real-time batch record review (including development and engineering batches) to ensure accuracy completeness and compliance with GMP expectations.
• Monitor critical processes aseptic practices and operator techniques in a flexible evolving manufacturing environment.
• Ensure proper line clearance equipment setup verification and status labeling across multi-product or campaign-based operations.
• Review and approve GMP documentation including executed batch records logbooks protocols and reports.
• Identify document and escalate deviations non-conformances and compliance risks in a fast-paced pilot environment.
• Lead or support investigations root cause analysis and implementation of corrective and preventive actions (CAPAs) with emphasis on continuous improvement.
• Ensure data integrity principles (ALCOA) are maintained across both development and GMP documentation.
• Participate in change control deviation management CAPA and audit readiness activities particularly for new or evolving processes.
• Support internal audits regulatory inspections and client audits including readiness for early-phase (Phase I/II) GMP manufacturing.
• Ensure compliance with regulatory requirements (FDA EMA ICH guidelines) while supporting innovation and speed.
• Support electronic documentation management system administration and use as required.
• Partner closely with Manufacturing Process Development Quality Control Validation and Engineering teams to ensure seamless execution of pilot operations.
• Provide QA oversight for new process implementation ensuring appropriate documentation risk assessments and controls are in place.
• Support development of batch records SOPs and control strategies for new or modified processes.
• Mentor other QA staff and assist in training personnel on GMP expectations in a development-stage environment.
• Perform other duties as assigned in support of quality and operational objectives.

• Bachelors degree in Biology Microbiology Biochemistry Pharmaceutical Sciences or related field and 10 years of relevant experience.
• 47 years of QA experience in a GMP-regulated pharmaceutical biologics or vaccine manufacturing environment.
• Strong working knowledge of cGMP regulations aseptic processing and regulatory expectations (FDA EMA ICH).
• Demonstrated experience providing on-the-floor QA support in a manufacturing environment.
• Proven experience with batch record review deviation investigations and CAPA management.
• Ability to independently assess quality risks and make sound decisions in real time.
• Strong attention to detail technical writing and documentation skills.
• Effective communication skills with the ability to influence cross-functional teams.
• Experience supporting regulatory inspections (e.g. FDA EMA).
• Knowledge of quality systems such as TrackWise Veeva or similar platforms.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Constantly will be required to perform sedentary work that primarily involves sitting/standing.
• Occasionally will be required to perform light work that includes moving objects up to 20 pounds.
• Occasionally will be required to push or pull less than 25 pounds push or pull 25 45 pounds and reach above shoulder level.
• Rarely will be required to push or pull more than 45 pounds.
• Occasionally required to reach above shoulder level.
• Constantly will be required to use both hands.
• Occasionally will be required to stand or walk for more than 25 minutes and bend reach or twist repeatedly.
• Occasionally will be required to kneel squat or stoop and crawl or climb.
• Constantly will be required to have clear vision (near and/or far) depth perception peripheral vision and/or visual acuity.
• Occasionally will be required to ascend or descend ladders stairs scaffolding ramps poles and the like move self in different positions to accomplish tasks in various environments including tight and confined spaces and move about to accomplish tasks or move from one worksite to another.
• Constantly will be required to communicate with others to exchange information.
• Rarely will be required to operate machinery and/or power tools and operate motor vehicles or heavy equipment.
• Constantly will be required to assess the accuracy neatness and thoroughness of the work assigned.
• Occasionally required to work in low temperatures high temperatures outdoor elements such as precipitation and wind in noisy environments in hazardous conditions poor ventilation and in small and/or enclosed spaces.
• Occasionally required to work were no adverse environmental conditions are expected.
• Occasionally will be required to wear PPE including but not limited to gloves face shields/goggles safety glasses and safety shoes lab coat and ear plugs/muffs.
• Constantly will be required to wear a clean room uniform.
• Occasionally will be required to wear disposable dust/surgical mask and wear respirators such as a disposable respirator mask (N-95) half-face/full-face style PAPR SCUBA.
• Occasionally will come in contact with chemicals such as aerosols biological inhalants plastics inorganic dust and powders etc.

Please submit your resume online at . 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.