Spec, Quality Sr - ESO in San Juan Capistrano, CA at Quest Diagnostics

Date Posted: 7/9/2021

Job Snapshot

Job Description

Spec, Quality Sr - ESO- San Juan Capistrano, California

Position Summary:

This position is intended to drive quality management system (QMS) solutions to support evolving standards and regulatory environment, company growth, and continuous improvement.

Serve as the primary quality contact and host for study sponsor audits for Quest’s laboratories located in San Juan Capistrano, CA.  Guide and coordinate activities that support study sponsor and business partner audits, from planning through closure.  Support initiatives related to ISO certification.  Support development of general quality systems.  Analyze quality management data and information from various sources; present to management upon request.  Collaborate cross-functionally in support of risk assessments and development of risk mitigation strategies.  Adhere to internal policies and procedures in accordance with regulatory requirements and standards of practice (ISO, CLIA, CAP, state regulations, and other regulatory requirements), as well as the expectations of business partners.  Maintain a collaborative, positive, and professional demeanor and effective working relationships with stakeholders. 

Duties and Responsibilities:

Serve as the Quality lead for sponsor/client quality assessments (e.g., audits, questionnaires).

-                 Manage and maintain the audit schedule.

-                 Serve as the quality liaison between sponsor/client and testing laboratory and laboratory support functions.

-                 Serve as the primary contact for on-site audit scheduling, planning, and follow-up activities.

-                 Track quality commitments, such as responses, actions, ownership, and target completion dates.

-                 Review responses prior to delivery to sponsor/client.

-                 Provide support for bridging sponsor/client quality management expectations with a clinical laboratory quality management model.

•         Lead the improvement of general quality systems and internal controls in accordance with regulatory requirements, standards, and business needs, including general policies and procedures that support the management of laboratory services and service requests related to sponsored clinical studies and other associations with business partners.

•         Provide support for ISO audits and other initiatives related to ISO certification.

•         Participate collaboratively in the development of effective remedial action, CAPA, and quality improvement initiatives owned by various departments.

•         Provide support for performing gap and trend analyses.

•         Provide support for agency inspections.

•         Maintain effective working relationships with internal and external stakeholders.

•         Maintain working knowledge of applicable regulations, standards, and industry practices for quality management.

•         Analyze identified or potential quality system gaps, as well as trends and commonalities from audits; provide/present information and outcomes to management upon request.

•         Participate in developing/consulting on strategies for improvement of the QMS and appropriate metrics.

•         Participate in identifying risks, assessing risks, and developing risk mitigation strategies;

•         Provide support for QMS initiatives that span across multiple business units (up to 10% travel).

•         Participate on multi-disciplinary teams and perform other related duties as requested by the Quality Director.

Qualifications:

•         Bachelor’s degree in a Science discipline.

•         5+ years successful employment in a healthcare or life science environment. Experience in working effectively in a FDA-regulated environment preferred

•         Most duties are performed while sitting at a desk, (i.e., operating a computer or typewriter, using a telephone, or writing and analyzing data and/or reports). Walking or standing within the office area may be required for the operation of other office equipment and for meetings. Periodically, duties are performed while standing or sitting in a laboratory and may require manual dexterity and visual acuity in the operation of equipment. Some operations include the use of chemicals that requires following safe handling procedures. While performing the duties of this job, the employee is frequently required to use hands to finger, handle or feel objects, tools or controls and reach with hands and arms; in the operation of equipment or instruments located in the work environment. The employee is frequently required to sit and occasionally required to stand, walk, and stoop. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close and distance vision, ability to distinguish color, and depth perception.

•         Quality auditor, quality engineer, or Six Sigma certification (or similar) preferred.

•         Experience in applying quality management concepts and systems-based thinking.

•         Change management

•         Process improvement

•         Policy/procedure writing

•         Project and relationship management

•         Analytical and problem-solving skills

•         Organization and time management skills

•         PC skills and proficiency in MS Office applications

•         Excellent interpersonal communication, written and verbal

•         Ability to develop effective communication and operating practices and conventions

•         Ability to interact with and influence people at all levels effectively through collaboration and solution

•         Ability to define problems, collect reliable/accurate data, establish facts, and draw valid conclusions from data. Work performed in designated areas may require the use of appropriate safety precautions and protective equipment, including safety glasses, gloves, etc.