COORD, QA & COMPLIANCE
COORD, QA & COMPLIANCE
Perform a variety of duties associated with the Duke Translational Medicine Institute (DTMI) Quality Systems Unit (QSU), including maintaining and enhancing compliance to standards set forth by regulatory and accreditation agencies; developing a culture of quality among the programs overseen by the QSU; generating, tracking, trending, and interpreting quality related metrics and data;qualifying critical suppliers; review and release of manufactured products; manage unexpected events and develop corrective actions; quality and release materials; audit of programs under QSU purview;and provide continual quality training to new and existing staff members.
- Develop collaborative relationship with the CCBB, STCL, CT2 and APBMT program management.Assist QSU management in implementing and enhancing new and existing quality systems.
- Assist in maintaining inspection ready programs.
- Recognize and propose resolutions to identified gaps in the quality systems.
- Perform quality related tasks (e.g. Environmental Monitoring) that generate data, and be able to analyze, track,and trend data generated from these tasks.
- Be able to recognize alarming trends associated with these data and alert QSU management.
- Participate in internal audits, assisting the lead auditor with identifying deficiencies within the programs.
- Participate in departmental meeting and actively engage other members of the QSU in determining a resolution to the presented topics.
- Serve as final QA signature, as appropriate, on documents, events, and batch records.
- Ensure that products leaving the control of the facility are free of any unexpected or unexplained events.
- Ensure that identified events are communicated clearly and resolved as efficiently as possible.
- Assist programs with event management.
- Work collaboratively with end users on investigating,documenting, and proposing resolutions to these events.
- Work collaboratively with other members of the QSU on event management and take an active role in participating in these discussions.
- Ensure that follow up and corrective actions are being performed and documented appropriately.
- Ensure that the events route through the event management system in a timely manner.
- Assist QSU management in the design and review of reporting procedures to serve the purposes of quality assurance and quality improvement.
- Stay abreast of new developments in the field of Quality Assurance and Quality Control; recommend new policies and revise existing policies/procedures for compliance standards.
- Inspect, approve or reject all incoming materials for Programs covered by the QSU, including the Carolinas Cord Blood Bank (CCBB), the Robertson Clinical and Translational Cell Therapy (CT2) GMP Laboratory, Stem Cell Laboratory, and Adult Apheresis Clinic. The list of Programs covered may expand in the future.
- Train users on how to generate Material Specification forms and serve as final QA sign off on these documents.
- Assist with critical component verification and critical component stability programs.
- Assist in the investigation of supplies that may fall under a recall or other supplier related action that may impact product quality.
- Assist with qualification of suppliers and vendors supplying these materials.
- Perform routine QC record review for program.
- Identify any errors/deficiencies and ensure that these are communicated to applicable personnel and resolved as efficiently as possible.
- Assist with other quality functions including performing and documenting quality
- Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
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 off set years of experience on a 1:1basis.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
- Professional and positive demeanor
- Experience in research laboratory environment preferred
- Attention to detail
- Excellent people skills
- Ability to work well under pressure
- Ability to organize workload and handle several projects at a time
2228 COORD, QA & COMPLIANCE
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, genderidentity, national origin, race, religion, sexual orientation, orveteran status.*******************************************************Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires a bachelor's degree in a science or related field toacquire the appropriate cognitive, communicative and statisticalreporting skills.
Work requires two years of experience in clinical laboratory analysis,clinical laboratory quality assurance or related position. A relatedmaster'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.