Quality Assurance Coordinator

Provide administrative and coordination support to the Quality Assurance Department.  Responsible to support maintenance, monitoring, publishing, and reporting on the progress of the Quality Management Systems (QMS).  Provides assistance with audits, inspections and meetings including travel scheduling, coordination of staff attendance.  Assist Quality Assurance department with the post audit/inspection/meeting activities including minutes, follow-up on deliverables with outside departments and tracking and closing of CAPAs.

Responsibilities:

  Administration

• Maintain paper and electronic documents to ensure all are retained according to departmental requirements
• Provide data-entry services in departmental systems.
• Assist in the facilitation and coordination of the development of quality management system including policies, SOPs, Work Instructions and Guidance documents.
• Coordinate with department members to assemble metrics reports. 

Quality Audits, Inspections and Assessments

• Assist with inspections, assessments and sponsor, vendor, regulatory audit activities, which may include the preparation for audit/inspection (e.g., print documents, agenda, book and prepare the audit room).
• Review SOP binders and Work Instruction binders to ensure they are complete and accurate prior to an audit/inspection.
• File copies of notes taken during the audit/inspection and copies the documents requested by the auditors.
• File audit/inspection documents in the QA files.
• Send audit certificates to the study team (site audits) or to the team/department (internal audits).
• Communicate with other departments on progress of audit response (e.g., CAPA) items. 

Meetings

• Schedule and manage meetings including the scheduling, agenda planning, and meeting minutes as needed.
• Provide assistance related to meeting attendees including travel arrangements.

Qualifications:

The successful candidate will have an undergrad degree, or a college degree/diploma with 1-3 years of ongoing related experience. They will have a good understanding of GCP and quality control processes.

Working Arrangements:

Hybrid (in office 2-3 days per week).

  *Accommodations for job applicants with disabilities are available upon request