Remote Director Laboratory Operations Jobs in Chicago, IL

Brief Description

The Technical Assessor, CAP 15189 is responsible for:

• Supporting the Lead Assessor in the management of the accreditation process for assigned participating laboratories including:
  • initial introductions through onsite assessment,
  • reporting, and
  • ongoing account monitoring.
• Serving as customer contact to provide guidance in the interpretation of technical requirements throughout the CAP 15189 accreditation cycle.
• Evaluating continued conformance to ISO standards that require technical expertise.
• Serving as a team assessor member.
• Supporting Lead Assessor(s) in the technical review of nonconformity responses for assessed laboratories.
• Working with minimal support from the Lead through diversified procedures and policies, requiring analytical and interpretive thinking, and excellent organization and account management skills.
• Applying problem-solving abilities as situations warrant.

Specific Duties

Primary duties and responsibilities of the Technical Assessor, CAP 15189:

• Complete initial and all ongoing required assessor training.
• Review new lab enrollee applications.
  • Participate in introductory conferences as directed by the Lead with new laboratories to outline program requirements, expectations, and projected timelines.
  • Address any initial concerns or guidance needs laboratories may have about the program as related to technical role.

• Participate in onsite or remote initial Conformance Readiness Assessments, i.e., Gap or Pre- assessments, with newly enrolled laboratories:
  • Provide technical input on the findings report on the laboratory’s preliminary ISO assessment.
• Periodically within pre-determined timelines and on an ongoing basis, review assigned laboratory performance information including:
  • annual customer internal audit,
  • management review,
  • quality indicators,
  • surveillance,
  • Proficiency Testing participation, and
  • other information received from the laboratory or extracted from cap’s systems.
• Provide assigned laboratories with feedback on review and guidance on issue resolution within specified timelines.
• Support the Lead Assessor as assigned in the coordination of onsite or remote visits and conference calls.
• Conduct assessments demonstrating attributes that are:
  • ethical,
  • non-punitive,
  • diplomatic,
  • decisive,
  • perceptive,
  • versatile,
  • tenacious,
  • supportive, and
  • aimed at encouraging continual improvement.
• Participate as the technical team member at onsite or remote assessments including  supporting interviews with:
  • laboratory director,
  • laboratory staff,
  • hospital administrators,
  • medical staff representatives, and
  • others, as appropriate.
• Support the Lead in the completion of post document review and onsite visit paperwork in the designated timeframe including the Assessor’s Report to the laboratory that clearly documents and describes the degree and evidence of conformance. (Assessment Summary Report).

• Review post-inspection nonconformity responses for technical completeness and appropriateness.
• Request, in writing (or email), clarification of responses, additional information, and proficiency testing enrollment verification as necessary.
• Escalate concerns to Lead to implement appropriate follow-up for laboratories that have exceeded established time limits for responding to nonconformities or other time specific activities.
• Provide Program participant phone support on a periodic basis, or more frequently for those laboratories that may need more guidance as related to technical assessments.
• Monitor turn-around-time pertaining to assessor technical review as necessary.
• Perform other assignments and special projects as requested by the Lead Assessor or Director, CAP 15189.

Knowledge/Skills Required/Preferred

Personal:

• Must possess excellent oral and written communication and interpersonal skills.
• High degree of motivation, self-initiative, and ability to work with minimal supervision.
• Able to be decisive and demonstrate sound judgment.
• Strong and well-developed analytical and critical thinking abilities.
• Able to apply medical laboratory technical knowledge effectively in multiple scenarios.
• Excellent time management and organization skills.
• Solid troubleshooting skills necessary.

Professional:

• Medical laboratory technical expertise and quality management operations orientation.
• Excellent communication skills are essential for an assessor to be successful in evaluating and managing a client’s conformance to ISO 15189.
• Must be a team player oriented to sharing information to support and strengthen CAP 15189 assessment activities.

• Strong knowledge of quality assurance practices and accreditation or certification programs.
• Proven ability to manage multiple projects.
• Flexibility to adapt to changing priorities.
• Able to manage multiple laboratory clients in the performance of surveillances.

Technical:

• Strong computer literacy in Microsoft Office and Excel products required

Education/Experience

Education:

• See Experience 

Experience:

• Experience in ISO 9001,or ISO15189 in the performance of  internal audits and/or other quality management system – standards preferred.
• Experience in conducting external inspections or audits preferred.

Related certifications:

• MT (ASCP), MLT(ASCP) or equivalent required

Additional Criteria

• Extensive Travel (50% - 75%) Required to conduct onsite audits
• Salary: $87,000 - $111,000