This position is a member of the Quality Assurance group responsible for assuring compliance with Navigate BioPharma Services, Inc. internal procedures, CLIA regulations, College of American Pathologists (CAP) guidelines and state and federal regulations as applicable for a clinical trial/in vitro diagnostic development testing laboratory. This includes the development, implementation and maintenance of quality assurance (QA) systems and activities related to GXP (GCLP, GCP, GMP) and internal auditing.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Support QA activities and provide QA oversight within CLIA/biopharma laboratory to ensure compliance for clinical trial specimen testing to CLIA/GCLP/GCP requirements
Assist in internal audits on clinical trial testing and related documentation
Evaluate and provide guidance on risk assessment, impact, root cause analysis and corrective preventive action for quality events (deviations, CAPAs, complaints, audit findings)
Analyze quality-related data, identify issues or trends, and make recommendations to management
Maintain laboratory certifications and state licensures
Develop and monitor quality improvement initiatives and quality metrics in the laboratory
Perform quality review and approval of laboratory procedures, technical protocols/reports and testing records
Other duties as assigned
This position requires an individual with a clear understanding of, and experience in the quality systems and regulations listed above. Duties will include planning, organizing and collaborating with other team members for the implementation, training, operation and future enhancements of these quality systems. This positon requires a strong communicator and collaborator who can work with internal customers and external customers as required.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Note: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
o Minimum, BS/BA in medical technology, molecular biology, chemistry or life science
o Licensed Clinical Laboratory Scientist or equivalent preferred
o Years of Experience Required: 7-10 years experience in a Quality Assurance role with a combination of experience in:
GCLP and CLIA/CAP environments supporting all phases of clinical trials
FDA regulated environment supporting companion diagnostics or molecular diagnostics
Required Skill Sets & Knowledge
o Strong communication and collaboration skills
o Ability to give clear guidance to internal customers
o Strong working knowledge of the principles and practices of laboratory QA and QC
o Strong working knowledge of CLIA/CAP, GCLP, GCP
o Understanding of risk-based practices in a GCLP/clinical trial testing laboratory environment
o Basic understanding of molecular biology, immunohistochemistry, flow cytometry, fluorescent in situ hybridization a plus
o Good computer skills; WORD, EXCEL
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to sit for extended periods of time reviewing and generating electronic and written data. Use a computer keyboard. Ability to distinguish between colors (e.g. warning lights on equipment). Ability to view and interpret computer screens and hear audible equipment alarms. Ability to work in an open office work environment and in manufacturing and lab areas.
While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.
The laboratory work environment involves moderate exposure to unusual elements including: extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company s Safety and Injury, Illness and Prevention Plans.
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