Basic Function and Scope of Responsibility:
Under the direction of the Clinical Laboratory Director and Director of RA/QA, the Quality Manager will implement and perform functions in support of the Quality Management System (QMS) which assures a foundation for laboratory quality and compliance with federal, state and accreditation bodies to ensure laboratory inspection readiness at all times and provides a basis for long-term continuous improvement.
Essential Job Duties:
- Ensures laboratory compliance with all applicable regulatory and accreditation agencies in collaboration with the Laboratory Director.
- Provide continuous mentoring and coaching of the Quality and Metrology teams, supervisors, CLSs or peers and direct the activities for other laboratory associates to ensure and enhance compliance to established process requirements.
- *Oversee the administration of the clinical laboratory’s internal and external proficiency testing programs, including collation of data and ensuring review of results and corrective action, as applicable.
- *Oversee and assist in investigations and closure of non-conforming events, client complaints, and revised reports, ensuring that responses are accurate and complete, as well as ensuring that immediate, short-term, and long-term corrective actions are implemented and documented.
- *Oversee and assist with administration of processes used for management of instrument maintenance activities and environmental monitoring used to ensure compliance with manufacture recommendations and regulatory standards including review of records of completion, and evaluation of patient impact as needed when failures are found.
- Oversee and assist in administration of the critical material process for incoming materials and components, ensuring only qualified manufactured reagents/components are put into use.
- Oversee and assist in administration of the qualification and delegation process for laboratory associates ensuring collection of credentials and review for meeting regulatory standards and requirements and executing requested delegations meet requirements.
- Oversee and assist in administration of the training, competency and continuing education programs ensuring compliance with applicable requirements.
- Assist RA/QA Director with defining, monitoring, and reporting Regulatory and Quality department Key Performance Indicators (KPIs) and improvement metrics and documenting appropriate follow up when metrics do not meet defined parameters.
- Support, implement and ensure compliance of all department and company QMS related policies.
- Perform department quality related activities (PT reviews*, NCE/CAPA review and closure*, reviewing maintenance records*).
- Identify relevant quality-related training needs and facilitate delivery of training with Quality Specialist and department leadership.
- Consistently notifies Management of possible compliance issues and suggests/facilitates corrective actions.
- Hosts Monthly Clinical Quality Meeting and supports Quality Council meetings by ensuring accurate presentation of KPIs and data, minutes are recorded, and any action items are followed-up and presented.
- Monitors and manages Quality team processes relative to agreed upon goals. Work with individuals and/or team to develop creative solutions to maintain the quality and meet goals.
- Collaborate with other leaders on strategic planning for process improvements by partnering with management of Process Improvement program.
- Provide information to, and respond to questions from, associates about quality-related issues.
- Consistently demonstrates a high level of initiative and problem-solving ability.
- Coordinates efforts to effectively work with others in a way that is productive and promotes teamwork and change.
- Ability to partner directly with department managers to assist them in carrying out their responsibilities.
- Responsible for hiring, firing, and performance appraisals.
- Projects a positive, professional demeanor at all times.
- Perform other duties as assigned by the Clinical Laboratory Director or Director of RA/QA.
- Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times.
*indicates CAP/CLIA supervisory experience
Essential Knowledge, Skills and Abilities:
- Must meet requirements for CLIA/CAP/NYSDOH General Supervisor.
- Bachelor’s degree or higher in a chemical, physical, biological, or clinical laboratory science (MT/MLS/CLS with certification, preferred).
- Four years clinical laboratory experience in a high complexity setting
- Five years of experience with clinical laboratory Quality Assurance, Laboratory Quality processes or Quality Improvement
- Five years previous experience in a leadership position
- Experience with laboratory regulations and accreditation standards are required
- Understands clinical laboratory operations
- Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
- Ability to prioritize and decide appropriate course of actions.
- Strong interpersonal communication skills
- Ability to interact with associates at every level
- Demonstrated strong writing and composition skills
- Keen attention to detail
- Proficient use and skill of PC based software programs
- Willing to work outside normal business hours as job dictates
- Ability to make independent decision regarding matters of significance
Physical Requirements:
- Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead.
- Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting.
- Ability to continuously operate a personal computer for extended periods of time (4 or more hours).
- Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions.
The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Eurofins Viracor LLC is an equal opportunity employer and encourages individuals from all backgrounds to apply. By submitting your application, you acknowledge and agree to the following conditions:
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Drug Screen: Successful candidates will be required to pass a standard drug screen as part of the pre-employment process.
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Background Check: A thorough background check will be conducted for all potential employees. This may include, but is not limited to, criminal history, education verification, and employment history.
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Visa Sponsorship: Eurofins Viracor LLC does not sponsor employment visas. All candidates must have the legal right to work in Lenexa, KS without requiring sponsorship. Unless approved by HR and supporting parties.
Schedule:
- Monday-Friday 8:00am-5:00pm
What we offer:
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
