Senior QA Document Control Specialist

Overview

We are seeking a Senior 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.
• Conducts periodic reviews of controlled documents to ensure accuracy, relevance, and compliance with regulatory requirements.
• Oversees controlled document training assignments and ensures training compliance in coordination with other departments.
• Leads continuous improvement initiatives for documentation practices and systems, including communication and training on cGMP documentation and quality systems.
• Coordinates document review and approval workflows with cross-functional teams and fulfills quality assurance (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 both electronic and hard copy formats, including traceability of document locations.
• Copies/scans and archives/files 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 communicates externally per PBF communication guidelines and polices.
• Ensures timely processing of quality notifications and QA client deliverables.
• Tracks and trends quality notifications, quality statistics, and department performance as requested by leadership.
• Assists with validation documents as directed by the QA Manager.
• Controls the distribution of copies of official SOPs and forms, which include those in the satellite SOP notebooks throughout the facility.
• Manages PBF document archives in both 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.
• Assists in supplying documentation support during audits and serves as a backup to other QA staff members as needed.
• 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 duties as required and assigned.
• Attends required safety training and reports safety concerns to the facility Safety Officer.

Secondary Responsibilities

• Attends Quality Management Review Meetings, whether in person or virtually, to present inputs, take meeting minutes, and/or represent the QA Team, if needed.

Qualifications

• A bachelor’s degree in a life science, technical discipline, or a related field and 10+ years of experience, or an equivalent combination of education and credentials.
• A Minimum of five (5) y