SR Spec Technical Ops (Remote)- San Juan Capistrano, CA req55515 in San Juan Capistrano, CA at Quest Diagnostics

Date Posted: 1/19/2021

Job Snapshot

Job Description

Job Summary
To support Esoteric regional Operations projects in a company wide effort to drive growth, operational excellence and to provide technical and operational expertise to Esoteric labs. This person will work with National and Esoteric Technical Operations leaders to develop standardized processes relating to the management of an efficient workflow, medical quality and reporting of results on equipment and laboratory information systems.

Job Duties and Responsibilities
• Provide technical expertise and support for Standardization initiatives, including LIS standardization and Esoteric process standardization
• Work with Esoteric and National leaders, Local Operations, QIS, and IT to develop interface specifications, test standards, and provide training and support for new equipment, software changes to current platforms, interface functionality enhancements and other LIS standardization initiatives.
• Work in regional labs – across multiple esoteric sites with current working knowledge of legacy and standard LIS and workflow processes – to improve and standardize processes relating to the management of workflow and reporting of results on equipment.

Responsibility areas:
o Define interface requirements, development, testing and training to meet customer requirements.
o Audit laboratories for non-conformance to process standardization.
o Develop training documents and other tools relating to LIS standards and deployment.
o Develop LIS testing protocols
o Liaison between national leaders, operations, compliance, QIS, and IT to drive requirements and standards for instrument interfaces
o Drive instrument interface standards and functional tools for regional consolidation and QSuite conversion activities
o Provide support for equipment choice/software upgrades – esoteric and national leader relations, supplier interaction to determine impact to LIS.
o Maintaining supplier relationship in support of instrument workflow standardization and resolve issues relating to interface development.
o Work with IT resources to ensure interface requirements are met and coordinate regional testing & training to test systems and applications.
o Coordinate resolution with Medical/esoteric leaders/national leaders/QIS/IT/regional ops instrument interface issues
o Liaison between operations and suppliers to resolve issues
relating to interface development
o Assist IT and the lab to resolve issues that surface during process gap analysis, instrument set-up and validations, work with esoteric and national leaders and local operations to mitigate problems. Get final approval on interface documentation.
o Drive standardization of testing – esoteric processes and instrument interfaces – platform optimization.
o Define interface requirements, development, testing and training to meet 21CFR11 requirements.
o Develop training documents and other tools relating to documentation of 21CFR11 compliance

Accountabilities / Metrics
o Testing processes and standards
o quality service, efficiency
o Regulatory compliance
o Compliance issues
o Expense and Capital Management
o Adherence to budgets and guidelines

Job Requirements- Knowledge, Skills and Experience:
1. Bachelor’s degree or equivalent Minimum 5-7 years of experience in Clinical Laboratory environment. Extensive technical knowledge in desired technical discipline testing required.
2. Ability to multi-task
3. Possess excellent analytical skills
4. Ability to work independently or under minimal supervision
5. Must be self–starter
6. Ability to follow verbal or written instructions
7. Effective verbal and written communication
8. Comfortable with making independent decisions
9. Ability to exercise critical thinking and independent judgment in stressful environments
10. Ability to concentrate on tasks
11. Ability to adjust to quickly changing environment
12. Must be detail oriented
13. Must be flexible in schedule, both in days and hours
14. Required to sit for long periods of time for conference calls and travel
15. Possess strong computer skills (i.e. MS Word, Excel & Power Point)

Critical Know How and Skill – Selection Criteria
1. Clinical and technical expertise in Lab Operations, standard LIS functionality, instrument interface development, and workflow management
2. Experience with laboratory instrumentation and software (hands-on experience with laboratory automation and interface validation is a plus)
3. Experience with writing and editing SOPs
4. Experience with Process Improvement – QMS Bronze or Silver certification is a plus
5. Excellent oral and written communications skills with both technical and non-
technical information
6. Excellent presentation skills
7. Methodical, detail oriented, efficient, organized, highly productive
8. Excellent organizational, time management, analytical, and problem solving skills
9. Ability to work under pressure, managing multiple priorities, and complete tasks on time within a fast paced environment.
10. Positive “Can Do” attitude in approaching challenges
11. Cross systems view
12. Ability to think strategically
13. Ability to effectively collaborate with fellow team members and laboratory managers and staff
14. Effective at handling crisis management and prioritization
15. Up to 60% travel

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