Quality Management Specialist

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POST DATE 9/13/2016
END DATE 11/15/2016

HCA Healthcare Nashville, TN

Company
HCA Healthcare
Job Classification
Full Time
Company Ref #
25320-3488
AJE Ref #
576162429
Location
Nashville, TN
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Associates Degree

JOB DESCRIPTION

APPLY
Job Code: 25320-3488

Full-time

No Weekends

SARAH CANNON RESEARCH INSTITUTE (SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.

We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.

SUMMARY OF KEY RESPONSIBILITIES:

Oversees quality management processes and provides guidance and support to operational teams within SCRI Services to meet GCP and regulatory requirements in the conduct of clinical trials. Assists in hosting Sponsor and regulatory audits and conducts internal, site, or vendor audits as assigned. Works closely and effectively with research directors, clinical trial Sponsors, project study teams, and outside consultants.

DUTIES AND RESPONSIBILITIES:

Duties include but are not limited to:

* Providing guidance to research operations on the interpretation of corporate and regulatory requirements (standard/policies/procedures) related to quality management and GCP

* Performing quality functions and executing quality programs

* Assisting in the preparation, hosting, and follow-up of Sponsor audits/assessments and regulatory inspections

* Participating in the development and/or review of standards, policies, procedures, and work instructions to support the quality management system

* Conducting internal, vendor, and site audits, including planning, executing, reporting, and followup

* Developing quality plans and/or audit schedules as appropriate

* Identifying areas of deficiency and trends in quality and escalating to appropriate personnel

* Developing, modifying, and utilizing tools to track and trend compliance issues

* Developing timelines to ensure timely and appropriate follow-up in areas of deficiency

* Maintaining records to support quality processes and audits

* Educating, training, and mentoring staff in quality improvement methods

* Attending training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends

* Participating in divisional improvement efforts

* Maintaining knowledge of SDLC and validation methodology and audit systems, as assigned

* Providing support to the electronic quality management system, as assigned

* Performing related work as required

* Travel up to 40%, as assigned

MANDATORY:

* Practices and adheres to the Code of Conduct philosophy and Mission and Value Statement

* During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.

#LI-ND1

COMPETENCIES:

* Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience

* FDA regulations and GCP guidelines

* Pharmaceutical, biologics, and/or medical device industry

* Skills: The proficiency to perform a certain task

* Professional writing and communication skills

* Interpersonal skills

* Computer skills, including MS Word, Excel, Outlook; electronic data capture systems, electronic quality management systems

* Problem-solving skills

* Abilities: An underlying, enduring trait useful for performing duties

* Detail-oriented and meticulous

* Organized, ability to prioritize

* Analytical

EDUCATION:
Minimum Required: Associate Degree (2 yr program)
Preferred: Bachelor's College Degree (4 yr program)

EXPERIENCE:
Minimum Required:

* Healthcare research or other science-related field

* Previous experience in a GxP environment

* At least a year of experience

Preferred:

* Quality assurance, quality management, or quality auditing

* Working in a CRO or Sponsor environment

* Experience in computerized systems validation in a clinical trial environment

CERTIFICATIONS/LICENCES:
Certified Clinical Research Professional ASQ Certified Quality Manager or Certified Quality Auditor is preferred

Last Edited: 09/09/2016