GMP Quality Assurance (QA) Document Control Specialist

We are seeking a QA Document Control 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

Creates, processes, and maintains procedures, policies, forms, batch production records (BPRs), and other cGMP documentation within the PBF documentation system.

Coordinates document review and approval workflows with cross-functional teams and fulfills QA obligations for client deliverables.

Adheres to GMP and regulatory guidelines while maintaining a safe and compliant work environment.

Demonstrates fluency and expertise in PBF quality, documentation systems, policies, and processes.

Assists QA management in processing, reviewing, and maintaining SOPs, Forms, Batch Production Records (BPRs), trending charts, and other cGMP documentation.

Ensures the integrity of document version control and archiving.

Oversees PBF document archives in electronic and hard copy formats, including traceability of document locations.

Assists in copying/scanning and archiving/filing of PBF documents.

Processes labeling request forms for PBF manufacturing departments.

Provides guidance, training, and mentoring to PBF staff regarding cGMP documentation and quality systems.

Communicates effectively within project teams and externally per PBF communication guidelines and policies.

Ensures timely processing of quality notifications and QA client deliverables.

Controls the distribution of copies of official SOPs and forms, including those in the satellite SOP notebooks, throughout the facility.

Manages PBF document archives in electronic and hard copy formats, ensuring traceability and controlled distribution of official SOPs and forms throughout the facility.

Supports regulatory and client audits by supplying documentation and assisting with responses.

Provides other administrative support and assists other staff as directed by the QA Manager.

Maintains 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 light duties and other related duties as required and assigned.

Attends required safety training and reports safety concerns to the facility Safety Officer.

Qualifications

A bachelor’s degree in biotechnology or a related field.

Four years of experience employed at a Biotechnology, Pharmaceutical, or related facility, or have a background in a scientific field.

EDMS experience is required.

Smartsheet experience is preferred.

Must have advanced Word and Microsoft Excel skills, good grammar, spelling, proofreading skills, and attention to detail. Skills in Microsoft Access and LIMS systems are a definite plus.

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 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.

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 about to accomplish tasks or move from one worksite to another.

Constantly communicate with others to exchange information.

Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

Occasionally work in noisy environments.

Occasionally work in small and/or enclosed spaces.

Constantly work in environments where no adverse environmental conditions are expected.

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.

Regular Full-Time