COORD, QA & COMPLIANCE
COORD, QA & COMPLIANCE
The QA Coordinator position will report directly to the Deputy Director of the Quality Assurance for Duke Vaccine Immunogenicity Programs.
Following training, you will be required to perform quality assurance activities for groups maintaining compliance to Good Clinical Laboratory Practices (GCLP). Your position will be responsible for assisting laboratories transition from research and development to compliance,Standard Operating Procedure (SOP) creation/revision/document control, performing facility and in-process audits, working with laboratories to manage equipment maintenance/calibration records, and archival of records In terms of SOP creation/revision/document control, you will be responsible for the management of SOPs. This involves working with laboratory members in the incorporation of laboratory-specific procedures into the standard SOP template. Following incorporation of the procedure into the template, you will be responsible for formatting the SOP to be consistent with other SOPs that are in effect. In terms of SOP revision, you will be responsible for maintaining the schedule of review of existing SOPs. You will also be responsible for coordinating the revision process with key laboratory staff/management which includes incorporating suggested changes into a revised document. You will need to be able to read the SOPs critically to ensure the clarity and utility of the document. For SOP document control, you will distribute SOPs to the laboratory staff in a controlled manner and also be responsible for distributing uncontrolled copies of SOPs to outside researchers/institutions upon the request from the Principal Investigators/Laboratory Management. Additionally, you will be required to plan and conduct facility-based and in-process-based audits. Facility audits are more general and cover the entire laboratory#s operation and equipment. Examples of items examined include personnel/training records, facility access/maintenance, temperature monitoring records, equipment validation/maintenance/calibration records, safety equipment maintenance, reagent maintenance, positive control trending, and data management/archival. In-process audits are more focused on an individual procedure and involve following a laboratory operator from the beginning of an assay through the completion of an assay utilizing the SOP. Both types of audits will require a keen eye in observing the processes in the laboratory to identify processes that are non-conformant with established procedures outlined in SOPs. Following the audits, you will hold a debriefing of the audits with laboratory staff to disseminate initial findings in a non-confrontational and constructive manner. This requires both tact and diplomacy. You will also be responsible for composing reports to send to the laboratories following the audit. This requires good writing/communication skills and attention to detail. You will also be responsible for the collection of audit report responses from the laboratory and any documentation that support follow-up actions that are required. Your position will require a team-oriented person, with good communication and writing skills, and one who is highly motivated. You will need to be able to interact diplomatically with laboratory staff and Principal Investigators / Management to convey quality assurance findings in a tactful and constructive manner. This position also requires someone who is flexible as the QADVIP continually embarks on new projects within the scope of laboratory compliance.
2228 COORD, QA & COMPLIANCE
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Work requires a bachelor's degree in a science or related field to acquire the appropriate cognitive, communicative and statistical reporting skills.
Work requires two years of experience in clinical laboratory analysis, clinical laboratory quality assurance or related position. A related master's degree may offset years of experience on a 1:1 basis. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.