Quality Assurance Auditor Specialist

Job Locations US-MD-Silver Spring
# of Openings
1
Category
WRAIR PBF
Type
Regular Full-Time

Overview

CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.  This position will support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

  • Quality Auditor Specialist provides comprehensive quality support to PBF departments to ensure and enhance compliance with Good Manufacturing Practices (GMPs).  This includes support in the development of instructional documents (SOPs, batch production records), review of executed documents (batch records), internal 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.
  • Learns and maintains understanding of and training in the use of the PBF quality and documentation systems.  Follows existing Standard Operating Procedures (SOPs).
  • Follows current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations as they apply to all levels of work.
  • Assists departments in the creation of 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 to approved labeling specification.  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; be aware of and observe appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to the position.
  • Provide technical assistance to CAMRIS Headquarters as needed and participate on proposal writing projects when requested.
  • Performs light duties and other related duties as required and assigned.

Qualifications

  • Must have at least a BS/BA in biology or other life science field.
  • Must have been employed for a minimum of 4 years at a cGMP biotechnology, pharmaceutical, or related facility with at least 2 years of experience in QA.
  • Must have 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 a definite plus.
  • Must be able to work independently and with significant initiative.  Some nights or weekends may be required.
  • Aseptic gowning and entering cleanrooms may be required.
  • Must be able to follow directions and written policies and procedures for all work responsibilities.
  • Must have good people and communication skills (written and verbal).

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