Quality Specialist Mon-Fri 8am-5pm

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:

1. Drug Screen: Successful candidates will be required to pass a standard drug screen as part of the pre-employment process.
2. 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.
3. 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.

Basic Function and Scope of Responsibility: 

The Quality Specialist is primarily responsible for supporting processes for the Clinical Laboratory at Viracor with a focus on maintaining CLIA CAP and NYSDOH accreditation. The role requires expertise in managing facilitating and improving processes integral to the Quality Management System (QMS).

Essential Job Duties:

Level I:

• Manages one or more of the Quality processes (Training Competency Critical Materials Notifiable Disease Reporting Proficiency Testing Non-conforming Events Deviations and/or Change Management) by demonstrating the following responsibilities:

• Establish and define new or updated processes and verify as necessary with little direction from management.
• Ensure updates to processes and SOPs when updates to regulations/standards are published.
• Assist management personnel in developing and reviewing technical and operational policies and procedures.
• Provide continuous mentoring and coaching to less-experienced Quality Coordinators or peers.
• Ensure and enhance compliance to established quality process requirements.
• Review documents and records for GDP.
• Assist in developing methods for compliance to GDP.
• Provide consultation and direction to ensure processes are implemented at the highest standard.

• Demonstrates high proficiency in software programs or tools used in Quality.
• Develops updates to processes/procedures performs validation of updates edits SOPs trains and establishes good working relationship with other associates and vendors when applicable.
• Advises and assists management on QMS development and review.
• Coordinates efforts to effectively work with others in a way that is productive and promotes teamwork and process improvement.
• Assists in facilitating the Non-Conforming Event/Corrective Action Preventive Action processes including evaluating root cause analysis assessments to ensure they accurately identify root cause so that elimination or correction of the problem will prevent recurrence.
• Participates in continual quality improvement projects company-wide and conduct small projects within the department to successful conclusion.
• Reviews credentials and evaluates qualifications for clinical laboratory associates.
• Performs and/or assists with other duties as assigned.

Level II Fully meets responsibilities of Quality Specialist I plus:

• Reviews and assesses instrument and equipment maintenance and function check records at least monthly with delegated approval authority as designated by the Laboratory Director.
• Reviews Deviations Change Management Forms Non-conforming Events and Corrective Actions/Preventive Actions for completeness. Closes NCEs with delegated approval authority as designated by the Laboratory Director.
• Submits Proficiency testing results for formal events reviews Proficiency testing results for assay performance communicates PT outcomes with assay supervisor/manager and Laboratory Director and initiates NCE investigations as necessary. Reports external Proficiency Testing results within applicable timeframe.
• Reviews and assigns delegations as requested including management of requests for trainers or qualified personnel.
• Manages competency content as required.
• Performs and/or assists with other duties as assigned.

Qualifications :

Essential Knowledge Skills and Abilities:

Level I:

• BS or BA in biological chemical or clinical laboratory science with at least four years of clinical laboratory experience.
• Ability to mentor and coach others
• Ability to effectively escalate errors or non-compliance situations to those responsible while coaching expected outcome and communicating to management.
• Flexibility to adapt to changing task assignments and ability to handle multiple task assignments
• Demonstrated ability to effectively accomplish goals and complete projects in a collaborative setting
• Proven ability to work effectively with others and as a team member
• Superior oral and written communication skills.
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management.
• Working knowledge of good laboratory practices and laboratory test methodologies.
• High level of proficiency with commonly used computer programs
• Ability to work proactively in a very self-directed manner taking initiative as required
• Superior organization skills and detailed oriented
• Ability to make decisions with little or no supervision including generating data and performing analysis
• Familiarity of quality control concepts and methods including Westgard rules and Levey-Jennings graphs
• Demonstrated interpersonal and negotiation skills
• Creative individual with excellent analytical troubleshooting and decision-making skills
• Participate as an active member of the Laboratory Quality Committee
• Ensure continuous quality improvement by collaborating with management to implement standardization and process improvement initiatives with the department
• Position may require working hours outside of the normal work schedule when necessary

Level II meets all requirements for Level I plus:

• Minimum of 8 years of experience in a high complexity lab; inclusive of Viracor tenure as a Quality Specialist level I
• Progressively increasing experience and judgment to plan and accomplish goals  
• Ability to assist in determining overall priorities for department

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 lift and move items weighing up to 15 pounds.
• Physical dexterity sufficient to move body frequently around laboratory equipment and instrumentation.
• 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.

Additional Information :

Schedule:

• Mon-Fri 8am-5pm

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 USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time