Quality Assurance Manager

Overview:

We are seeking a Quality Assurance Manager  to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. 

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:

• Manages QA at the WRAIR Pilot Bioproduction Facility (PBF) overseeing Good Manufacturing Practices (cGMP) compliance, release, policies, and training.
• Guides PBF in advancement and implementation of current and project relevant compliance initiatives related to expansion of capabilities, multi-platform manufacturing, and expansion of capabilities such as monoclonal antibody and mRNA GMP production.
• Interfaces directly with PBF clients, WRAIR Quality and other QA counterparts representing both WRAIR PBF and CAMRIS.
• Leads audit preparation, audit responses and tracking of outstanding compliance initiatives.
• Oversees and leads broad Quality Assurance responsibilities, including the inventory of in-process and final released products, raw material control, staff qualification and training, document origination and control, and facilities and equipment validation and maintenance.
• Implements the following cGMP systems: personnel training, product deviations, failure investigations, critical change controls, corrective actions, internal and external auditing, and others as needed.
• Establishes, leads, and implements risk-based compliance approaches.
• Reviews, revises, and/or approves documents: IOQ documents, batch production records, and standard operating procedures.
• Dispositions drug substance and drug product produced at PBF to be released for clinical testing (final signatory authority).
• Supplies, leads, and generates briefs, as needed, on all matters of QA including the Quarterly Management Review.
• Supervises and manages the site quality team.
• Provides technical assistance to CAMRIS headquarters as needed and participates in proposal writing projects when requested.
• Maintain a safe workplace, ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. The employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
• Performs other duties as assigned.

Qualifications:

• Must have a BS/BA degree in biology or a related field and 12 years of experience at a biotechnology, pharmaceutical, or related facility, or an equivalent combination of credentials and experience.
• Experience in phase 1 manufacturing (preferably vaccine production, mRNA, and monoclonal antibodies).
• Requires a minimum of at least four years of experience in QA management/supervision in the areas of documentation control, raw material management, instrument calibration, validation, repair, facility system controls, internal and external audit competency, and compliance training expertise.
• Must have experience with FDA GMP facility oversight (preferred: design and startup experience, clinical phase manufacturing, and Annex 1).
• Demonstrated experience working with external stakeholders, quality technical agreements (QTAs), and quality aspects of subcontractor oversight.
• Knowledge of applicable highly complex office procedures and techniques relating to the position.
• Must be able to work independently following a brief period of specific technical training.

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Occasionally conduct light work that includes moving objects up to 20 pounds.
• Occasionally conduct medium work that includes moving objects up to 50 pounds.
• Occasionally conduct heavy work that includes moving objects up to 100 pounds.
• Rarely conduct very heavy work that includes moving objects over 100 lbs.
• Occasionally push or pull less than 25 pounds, push or pull 25 – 45 pounds, or push or pull more than 45 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes.
• Occasionally bend, reach, or twist repeatedly.
• Occasionally kneel, squat, or stoop.
• Occasionally crawl or climb.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
• Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Occasionally operate machinery and/or power tools.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Occasionally work in low temperatures.
• Occasionally work in high temperatures.
• Occasionally work in outdoor elements, such as precipitation and wind.
• Occasionally work in noisy environments.
• Rarely work in hazardous conditions.
• Rarely work in an area where there is poor ventilation.
• Rarely work in small and/or enclosed spaces.
• Constantly work in environments where no adverse environmental conditions are expected.

PPE and Chemical Requirements

• Rarely wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Rarely wear a lab coat.
• Rarely wear earplugs/muffs.
• Rarely work in a Clean Room Uniform.
• Rarely wear a disposable dust/surgical mask.
• Rarely wear a respirator, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
• Rarely 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.