Senior Quality Assurance Audit Specialist

Overview

We are seeking a Senior Quality Assurance Audit Specialist 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

• Provides comprehensive quality support to PBF departments to ensure and enhance compliance with current Good Manufacturing Practices (cGMPs). This includes support in the development of instructional documents [standard operating procedures (SOPs), batch production records], review of executed documents (batch records), internal/On-the-Floor (OTF) auditing for GMP compliance, mentoring/coaching employees in GMP compliance, participation in investigations, and follow-up to verify that identified corrective/preventive actions have been appropriately implemented. Also assists in the execution of other Quality Assurance department responsibilities.
• Leads in the implementation/revision of specific quality system projects.
• Learns and maintains an understanding of and training in using the PBF quality and documentation systems. Follows existing SOPs.
• Follows cGMP guidelines and FDA regulations as they apply to all levels of work.
• Assists departments in creating Batch Production Records, departmental procedures and policies, logbooks, etc.
• Performs review of completed batch records to determine compliance with all established, approved written procedures and works with departments to resolve discrepancies; monitors status of batch records until completed; prepares Certificates of Analysis for completed lots.
• Assists departments in the initiation of deviations.
• Assists in and conducts investigations.
• Works with departments to enhance compliance and productivity. Coaches and mentors staff to improve GMP understanding and application.
• Inspects labeling prior to use for accuracy, completeness, and compliance with approved labeling specifications. Performs label reconciliation after use.
• Performs internal audits to determine compliance with established, approved written procedures. Works with the audited department to resolve discrepancies and enhance compliance and productivity.
• Verifies that identified corrective/preventive actions have been implemented.
• Serves as an emergency responder in the event of freezer/refrigerator failure in order to protect inventory at risk.
• Maintains a safe workplace; observe appropriate safety and occupational health rules and regulations. The employee is required to attend safety training relative to the position.
• Provides technical assistance to CAMRIS headquarters as needed and participates in proposal writing projects when requested.
• Performs other duties as assigned.

Qualifications

• At least a BS/BA in biology or another life science field and 10 years of experience. Master's degree is preferred.
• A minimum of 6 years at a cGMP biotechnology, pharmaceutical, or related facility with at least 4 years of experience in QA.
• 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 are a definite plus.
• Able to work independently and with significant initiative. Some nights or weekends may be required.
• Aseptic gowning and entering cleanrooms may be required.
• Able to follow directions and written policies and procedures for all work responsibilities.
• Good people and communication skills (written and verbal).
• Must be eligible 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.

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 push or pull less than 25 pounds, or push or pull 25 - 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.
• Occasionally operate motor vehicles or heavy equipment.
• 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.
• Occasionally work in hazardous conditions.
• Occasionally work in an area where there is poor ventilation.
• Occasionally work in small and/or enclosed spaces.
• Occasionally work in environments where no adverse environmental conditions are expected.

PPE and Chemical Requirements

• Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Occasionally wear a lab coat.
• Occasionally wear earplugs/muffs.
• Occasionally wear a Clean Room Uniform.
• Occasionally wear a disposable dust/surgical mask.
• Occasionally wear a respirator, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
• Occasionally come in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust and powders, etc.

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.

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.