Careers

AllerGenis is seeking an Information Technology Leader to join our team. The consultant in this role will be responsible for IT strategy, data integrity and security, systems development and maintenance, and day to day IT operations.

How You Will Help Drive Our Success

Through your experience and expertise, you will:

• Lead IT strategy oversight and ITS management
• Manage the migration to new systems, e.g. MS Teams
• Strategize and manage our data integrity, security, and validation, e.g. Kaseya and supporting Novartis partnering work
• Manage our ongoing LIMS validation working and coordinating with our cloud-based partners
• Lead the development of a Registry data system, Epitope map database system
  
  

Who You Are

You will bring the following experience to our team:

• Writing validation protocols, running the required testing of those protocols and finally, writing up the results of that testing, as it pertains to computerized systems in the regulated healthcare space.
• Managing of IT systems regarding security, data integrity and personal privacy. Experience with these topics within the regulated healthcare space is a big plus.
• Planning tactically and strategically with little guidance from peers and executive management. Comfortable with ambiguity of goals.
• Managing relationships governing SAAS offerings. o Specifically, experience with Microsoft 365 is a must.
• Experience with additional providers would also be useful (beyond Tier 1 level such as Microsoft, AWS, or Google).
• Collaborating with varied personality types and interfacing with a diverse and widely dispersed set of biotech environment business domains: scientific, medical, laboratory, sales, operations, etc.; facilitation skills within these domains to ensure team efficiency and effectiveness.
• Leading and managing user IT in the modern world of WFH and BYOD as it applies to IT operations in general and more specifically as it applies to security, data integrity and privacy.
• Managing the IT environment of a business (preferably biotech) through contract relationships where helpdesk, development and network engineering is completely offloaded to strategic vendors, i.e. experience negotiating contracts

You will bring the following attributes to our team:

• Ability to function independently and as a member of a large team; motivate personnel to achieve excellence; work with multiple leadership and staffing levels to achieve quality management goals
• Must have excellent verbal and written communication skills
• Ability to investigate, analyze information/data and draw conclusions
• Ability to develop and present educational and training programs
• Demonstrated experience developing and maintaining positive professional relationships with physicians, employees, peers, and organizational leaders.

 

AllerGenis is seeking a Quality Manager to join our team. The consultant in this role maintains and continually improves the Laboratory Quality Management Program, managing and coordinating related activities and completing tasks to ensure effective support of Laboratory operations. Functions as the Laboratory Internal Audit Manager ensuring annual competency, continuing education credits, proficiency testing requirements and related quality measures. Work situations range from clinical to managerial and require independent decision-making, analysis, policy and program development, problem and issue resolution and leadership skills.

Coordinates the monitoring, reporting and assessment of performance-related information. Also, coordinates the quality review actions of the operations management team to ensure continual improvement of quality and service. Facilitates the design and validation of efficient workflow processes, conducts quality related meetings, and develops visual management documents of the analyzed quality data measures. Ensures regulatory compliance and accreditation readiness by maintaining up to date knowledge of requirements and coordinating activities to meet requirements. Promotes a culture of quality through education of the team.

How You Will Help Drive Our Success

Through your experience and expertise, you will:

• Prepare reports as required by Quality Management and accrediting agencies (Quarterly and annual Pl reports, annual review of effectiveness of CHP & Safe Work Practices, BBP Plan, QI plan)

• Write policies and procedures for the laboratory

• Be responsible for Safety Committee and maintaining records

• Ensure that a standard operating procedure (SOP) exists for all laboratories and that it meets all necessary requirements. Maintains an index of all Standard Operating Procedures (SOP) and a list of archived Standard Operating Procedures. Ensures that all staff has access to, has read, and has been trained on the new and modified SOP's.

• Keep up with changes in regulations from CUA, CAP and informs lab administrators and supervisor(s).

• Work with supervisors in completing requirements for new testing.

• Create responses to PT and inspection deficiencies.

• Assist with completion of licensure and inspection forms

• Keep Lab Administration (administrator and director) advised of all pertinent information

• Inform staff of policy and procedural changes in the laboratory

• Work closely with the medical director to develop and monitor clinical practice guidelines.

Who You Are

You will bring the following experience to our team: 

• Prior demonstrated successful experience in a multi structured health care institution or larger commercial laboratory

• Skillful knowledge of Microsoft Office programs, Laboratory Information Systems and Health Care Management Systems

• Demonstrated experience in quality systems, project management, and regulatory compliance with CAP, CLIA, JCAHO, OSHA Accrediting Agency standards

• Demonstrated experience with CMS, Press Ganey and HCAHPS in relation to patient satisfaction

 

You will bring the following attributes to our team:

• Ability to function independently and as a member of a large team; motivate personnel to achieve excellence; work with multiple leadership and staffing levels to achieve quality management goals

• Must have excellent verbal and written communication skills

• Ability to investigate, analyze information/data and draw conclusions

• Ability to develop and present educational and training programs

• Demonstrated experience developing and maintaining positive professional relationships with physicians, employees, peers and organizational leaders.