LAB RESEARCH ANALYST, SENIOR
LAB RESEARCH ANALYST, SENIOR
The incumbent in this position is responsible for highly complex and specialized testing of cellular products for clinical trials and commercial operations. In addition,this individual will be responsible for the supervision of and participation in QC testing in the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual will report to the GMP Facility Director. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies. The individual filling this position will supervise a QC team while applying project management knowledge, technical and interpersonal skills, and techniques to manage a variety of responsibilities while supervising and directing junior staff to achieve project goals.
- Responsibility for supervision of one or more Quality Control technicians performing QC and release testing in the GMP Facility.
- Management of all QC activities performed in the GMP Facility including, but not limited to, environmental monitoring, endotoxin testing, sterility testing, and flow cytometry.
- Develop, coordinate, and implement strategies essential to the successful management of QC tasks. Apply project management knowledge, technical and interpersonal skills, and project management tools to manage a variety of responsibilities, including development of SOPs, implementation of QC projects or validations (where required), and optimization of procedures.
- Supervise and direct junior staff to achieve project goals. Serve as a resource to GMP Facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects.
- Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality, and test results as needed.
- Oversee the validation of new QC tests as they are brought into the GMP Facility.
- Perform duties as dictated by standard operating procedures (SOPs)for QC and release testing of cellular product manufacturing and under G'X'P (GLP, GTP, GMP, GDP) guidelines as directed.
- When necessary, perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique. Operate QC instrumentation for environmental monitoring, and release testing, and perform assays to analyze and/or release a cellular product.
- Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification. Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
- Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness as well as provide recommendations or conclusions as appropriate.
- Tracking and trending of environmental monitoring data, and OOS results. Reporting these results to the Quality Systems Unit and lab management on a regular basis.
- Maintenance of all QC-related procedures and documentation, including review of all QC records and related documentation.
- Documentation and investigation of any QC-related out of specification (OOS) result.
- Assure remedial action is taken and documented whenever tests systems deviate from established performance specifications. Write and review validations, research plans and reports, SOPs, and batch records as required.
- Supervise QC activities for the facility, including tracking of maintenance calendar for equipment and checking of expiration dates for supplies.
- Supervise the maintenance of sufficient inventory of supplies and reagents for performance of QC-related testing; and ensuring laboratory space and equipment is clean and in good working order for the work.
- Routine meetings with management team for progress reports on projects, scheduling, and discussion of any other required items.
- Work with GMP Facility Director/Manager and Quality Systems Unit to ensure the facility is in compliance for governing regulations.
- Participate in lab inspections and work with inspectors as needed. Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.
2466 LAB RESEARCH ANALYST, SENIOR
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, gender, gender expression, genderidentity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
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 biology or other directly relatedscientific field.
Work requires five years of research experience. A related master'sdegree may substitute for three years of the required experience.Must have previous experience managing and leading projects.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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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.