Overview
Senior Quality Specialist Jobs in Olathe, KS at Lindsay
JOB SUMMARY
Neurocode is at the forefront of neurology testing, specializing in advanced diagnostics for neurological disorders such as Alzheimer’s disease and rare autoimmune disorders. We are seeking to augment our team with a dedicated and detail-oriented team-member to facilitate our mission of providing world-class neuroimmunology and neurochemistry testing.
The Quality Assurance Officer’s role is to work directly with the Neurocode leadership team in supporting and improving the Quality Management System (QMS). Develops, implements, monitors and improves the QMS in compliance with the corporate Quality Policy, corporate goals and objectives, and external regulations including Clinical Laboratory Improvement Act of 1988 (CLIA), College of American Pathology (CAP), and New York State CLEP clinical laboratory evaluation program (CLEP). Also considers US FDA Quality System Regulations (QSRs) and other worldwide requirements as appropriate.
ESSENTIAL JOB DUTIES
Promote the mission, vision, and values of the organization.
Develop, implement, communicate and maintain all compliance efforts, policies and programs.
Develops, implements, and continuously improves the QMS. Ensure compliance with regulatory/legal standards, and reports performance to leadership.
Evaluate regulatory compliance; conduct regular inspections and audits.
Defines, implements, and directs quality activities for new and existing testing services including adherence to Design Control where relevant.
Assists with facilities inspections by state, federal and international regulatory agencies, specifically CAP, CLIA, US FDA and Notified Body for ISO as relevant.
Ensure adherence to all relevant legal rules and regulations.
Carries out duties in compliance with established business policies and within budget.
Frequently interacts with peers and various management levels across the organization to ensure positive quality culture. Interaction normally requires the ability to gain cooperation of others, conducting presentations regarding quality procedures and initiatives and working cross-functionally with a relational collaborative approach.
Communicates with others to coordinate work and resolve issues related to quality as needed.
Provide effective guidance and direction to teams while creating an inclusive environment.
Maintains professional attitude and appearance.
EDUCATION/CERTIFICATION/LICENSE
High School Diploma or equivalent required; Bachelor of Science in biological Science required.
Current MLS certification by American Society of Clinical Pathologists or equivalent required.
EXPERIENCE
Minimum 3+ years of experience required:
Experience in Quality (QMS, QA, QC, and MA) in diagnostics environment.
Supervisory experience in a fast-paced environment.
High demand, fast-paced, exceptional client operations environment providing and understanding company services, and policies across multiple states and countries.
Development and management of operational standards which includes but is not limited to work, workflow, task assignments, policies, processes, and procedures.
Laboratory and/or healthcare environment whose focus is in clinical diagnostic testing is required.
Experience with electronic Quality Management System implementation is preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
Strong understanding and experience in implementation of best practice QA controls and audits.
Strong skills in data visualization.
Excellent understanding of project management principles.
Exhibits patience and approachability, sets positive tone and example for team member behavior, work ethic & quality, abilities, skills, and overall performance.
Demonstrates ability to maintain confidentiality at all levels, acts with high integrity.
Exhibits effective team supervision/management/leadership abilities.
Establishes and maintains solid interpersonal relationships with team members across all levels of an organization.
Demonstrates and facilitates professional communication skills; must be able to understand, listen, write, and speak fluently, professionally, and, effectively in the English language.
Motivated, responsible, and organized self-starter who excels at time management, timely follow-up, meeting commitments, and possesses a passion for continuous learning and improvement.
Strong attention to detail, analytical, research and problem-solving skills. Proactive ability to identify, assess, improve/refine and solve complex challenges, processes and/or situations.
The ability to successfully work collaboratively within a team and independently with minimal supervision.
Flexible and able to thrive in a fast paced, high growth, team-based environment while successfully handling competing and ever-changing priorities and responsibilities with frequent interruptions.
Solid record of accomplishment of taking responsibility and holding oneself accountable for high quality task deliverables within established deadlines.
Effective facilitation, collaboration, negotiation, and conflict resolution abilities.
Exhibit personal presentation in a professional manner as it relates to appearance, communication, and actions.
Proficient software/computer skills utilizing various applications which include, but are not limited to the following: MS Windows, MS Outlook, MS Word, MS Excel, MediaLab, ELIS, health care database/systems, etc.
Regular and predictable attendance and punctuality.
Focused on overall team success vs. solely on individual success.
WORKING CONDITIONS
We share a collaborative obligation to ensure that we conduct ourselves in the utmost ethical manner and that we hold each other accountable to the values and standards of the organization. Every employee is responsible for asking questions, seeking guidance, and reporting concerns and/or violations of company policy or ethical standards.
The organization has several processes in place to communicate with leadership and expects that employees will have a commitment to integrity and uncompromising values.
This position works in a demanding, fast-paced office and lab environment with the need to meet daily workload requirements. Incumbents may be exposed to chemicals and require the use of personal protection equipment and universal precautions.
This role routinely uses standard office equipment such as computers/keyboards/mice, printers, phones, mobile devices, photocopiers, filing cabinets, fax machines, etc. The noise level in the office work environment varies from moderate to loud.
PHYSICAL REQUIREMENTS
Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
While performing the duties of this job, the employee is regularly required to talk or hear; sit; stand; walk; use hands to finger, handle or feel; grasp and/or reach with hands and arms; repetitive movements of the wrists, hands and/or fingers.
Specific vision abilities required by this job include close visual acuity and ability to adjust focus to perform an activity such as: preparing and analyzing data and figures; reading reports, various forms charts or records, transcribing; viewing computer monitor(s); extensive reading.
The statements contained herein reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of responsibility but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties and/or work various shifts as assigned including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise to balance the workload. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the employer.
Job Type: Contract
Pay: $29.68 – $39.98 per hour
Schedule:
8 hour shift
Day shift
Work Location: In person
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Title: Senior Quality Specialist
Company: Lindsay
Location: Olathe, KS
