Senior Quality Assurance Specialist – On the Floor
5 days ago
Silver Spring
Overview We seek a Quality Assurance (QA) Specialist – On the Floor to support the Walter Reed Army Institute of Research’s 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 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 collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities • 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. Qualifications • Bachelor’s degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field and 10 years of relevant experience., • 4–7+ 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 where 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.
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