Quality Assurance Consultant : 356703

JobsRUs.com. is seeking to hire a Quality Assurance Consultant for our client in Nashville, TN!
Benefits Available!
Weekly Pay!
$38.46/Hour

What are must-have desired traits/experiences that the Manager would most like to see?
ICH E6 R3 Good Clinical Practices
An understanding of a quality management system based on ISO 9001
An understanding of KPIs, KQIs, how to collect and analyze these

Required/preferred experience:
Required:

Facilitate root cause analyses (Critical),
Oversight of the Change Management process,
Oversight of Management Review actions,
Oversight of business on-time deliverables to ensure activities are being completed on time, (CAPA/NC/CMR/MR); Notify stakeholders of actions due,
Managing Corporate Quality Assurance SharePoint sites that provide insight into GQE,
Collect Quality Agreements, site accreditations, and FDA registrations and ensure QA support teams have them available for review,
Managing Quality metrics business tool,
Assisting with a process to collect quality and operations metrics,
Assisting with analysis of identified quality and operations metrics,
Escalate identified trends to stakeholders that could lead to a non-compliance issue,
Identify metrics to escalate to executive leadership,
Facilitate document review and updates with business partners and appropriate QA colleagues,
Provide technical writing skills to develop and update documentation,
With business partners, QA, and T&E, identify reviewers, approvers, and trainee roles,
Assure governing regulations and standards are met in the documentation and associated training,
Assure updates to current documents are made upon the release of new versions of external documents,
Facilitate process flow mapping,
Educate, train, and mentor colleagues in quality improvement methods,
Support all external Sponsor, IRB, regulatory, or other audits of Development Innovations, Site Management Organization, and supporting departments, including but not limited to responding and appropriate follow-up of deliverables resulting from the audits,
May conduct or support internal, site, and vendor audits, as assigned, including planning, executing, reporting, follow-up, and tracking of action items resulting from those audits to completion.
Preferred: Certified Clinical Research Professional, ASQ Certified Quality Auditor, ISO 9001 Certified Lead Auditor, or Certified Medical Device Auditor
Additional Information you would like to add:

We need a person who understands a quality management system meeting ISO 9001. The ability to map processes, create and revise SOPs, facilitate root cause analysis with operations, an understanding of ICH E6 R3, clinical research requirements, and support internal/external customers.

Summary: Provide a general overview of the job’s key responsibilities, including responsibility level.
Provides guidance and support to Sarah Cannon Development Innovations or functional groups supported
by Corporate Quality, as appropriate, and the Quality Management Systems (QMS) processes to meet GCP
and regulatory requirements in the conduct of clinical trials. Manages Sponsor audits, assists in hosting
regulatory inspections, and conducts internal, site and vendor audits as assigned. Supports document and
training management, quality metrics, corrective and preventive (CAPA) actions and investigations, non-
conformance (NC) actions and investigations, deviations, and records management. Works closely and
effectively with Development Innovations, Corporate Quality, research Directors, clinical trial Sponsors,
clinical study teams, site colleagues, outside consultants, Information Technology Group (ITG), other Sarah
Cannon functional groups, and vendors, as needed.

Duties and Responsibilities: Document the duties and responsibilities that account for at least five percent of
the incumbent’s time or are critical to the successful performance of the job. List duties and responsibilities in
the order of criticality or those that require the most time.
Duties include but are not limited to:
Develop and maintain effective relationships with Sponsors, Sarah Cannon operational leaders,
operational colleagues supporting research activities and all other colleagues, as necessary
Oversight of controlled documents and training management processes in eQMS via
SmartSolve
Provide guidance to research operations on the interpretation of ICH-GCP, local and federal
regulatory requirements as related to the conduct of clinical research
Prioritize and escalate “Critical” and “Major” quality issues, identified procedural gaps
and/or other areas of deficiency. Report deficiencies to Executive and Physician leadership,
where appropriate
Manage and facilitate all external Sponsor, IRB, or other audits of Innovations, including but
not limited to preparation, hosting, responding and follow-up of those deliverables resulting
from the sponsor’s audits
Manage and facilitate any regulatory agency inspection of Innovations, including but not
limited to preparation, hosting, triaging, responding and continued follow-up of those
deliverables resulting from the regulatory inspection
Lead or participate in the development and/ or process improvements to standards, policies,
procedures, and work instructions to support the Quality Management System and Sarah Cannon
functional group processes
May conduct internal, site and vendor audits, as assigned, including planning, executing, reporting,
follow-up, and tracking of action items resulting from those audits to completion
Provide guidance and support for non-conformance resolution including root-cause analysis,

corrective and preventive actions
Develop, manage, and maintain quality management plans, where appropriate
Through routine trending and metric reporting, identify systemic areas of non-compliance and process
deficiencies. Propose and facilitate process improvements in areas of deficiency
Develop, modify, and utilize tools to track and trend compliance issues for value added feedback to the
business line
Develop and track timelines to ensure timely and appropriate corrective and preventive actions in areas
of deficiency
Maintain records to support the Quality Management System and any supporting documentation
Educate, train, and mentor colleagues in quality improvement methods
May attend training courses, relevant conferences or association meetings to continue to gain
industry trends and insight, and share that knowledge with internal colleagues, where necessary
May participate or lead divisional or departmental process improvement efforts
Perform related work as required
Travel up to 40%, as assigned
Mandatory: The following are mandatory expectations of all Sarah Cannon employees.
Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement.”
During your employment with Sarah Cannon, you will be routinely assigned training requirements. You
are expected to complete any training assignments by the due date.

Competencies: The baseline knowledge, skills, and abilities that are needed to be successful in the position.
Knowledge: A body of information needed to perform tasks; May be obtained through education, training or
experience.
Clinical Trial regulations as outlined by FDA, EMA, MHRA, PMDA, etc. and GCP guidelines
Pharmaceutical, biologics, CRO, 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.
Customer-focused
Relationship building
Detail-oriented and meticulous
Organized, ability to prioritize
Analytical
Education: The formal academic training which typically provides the knowledge and skills necessary for
successful job performance.
To enter an X in a check box, double-click the box and select “Checked” under Default value.

Minimum Education Required:
Bachelor’s Degree

Minimum Required:
N/A
Preferred:
Certified Clinical Research Professional, ASQ Certified Quality Manager or Certified Quality Auditor

Physical & Mental Demands and Working Conditions: On the job requirements including strength guideline,
motion parameters, vision and hearing requirements and work environment.
The physical demands described here are representative of those that must be met by a colleague to
successfully perform the essential functions of the job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
Ability to read, write and speak English. Requires prolonged sitting, some bending, stooping and stretching.
Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone,
calculator and other office equipment. Requires normal range of hearing and eye sight to record, prepare and
communicate appropriate reports. Requires lifting papers or boxes up to 25 pounds occasionally. Work is
performed in an office environment and involves frequent contact with staff and the public.
This job description provides a general outline of job responsibilities and requirements and is not intended to be
all-inclusive. Job responsibilities and requirements may change at any given time based on organizational and
departmental needs. By accepting the offer of employment for this position, colleagues assume the duties as
listed in the content of this job description. All updates to job descriptions are maintained electronically for all
colleagues to access at any time.