Senior Quality Assurance Audit Specialist

Camris•Silver Spring, MD

4d•Onsite

About The Position

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.

Requirements

At least a BS/BA in biology or another life science field and 10 years of experience.
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.
Able to work independently and with significant initiative.
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.

Nice To Haves

Master's degree is preferred.
Skills in Microsoft Access and LIMS systems are a definite plus.
Some nights or weekends may be required.

Responsibilities

Provides comprehensive quality support to PBF departments to ensure and enhance compliance with current Good Manufacturing Practices (cGMPs).
Assists in the development of instructional documents [standard operating procedures (SOPs), batch production records].
Reviews executed documents (batch records).
Performs internal /On-the-Floor (OTF) auditing for GMP compliance.
Mentors/coaches employees in GMP compliance.
Participates in investigations and follow-up to verify that identified corrective/preventive actions have been appropriately implemented.
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.