QA/Compliance/Safety Specialist - CA

QA/Compliance/Safety Specialist - CA - Sacramento, CA, Monday to Friday, 8:00 AM to 5:00 PM

This position is responsible for ensuring that all Quality, Compliance and Safety activities in the region are accomplished, necessary documentation is accurately completed, all measures and metrics are reported and appropriate corrective actions are executed and documented. 

Pay range: $96,910 - $174,350 / year

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits information:
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

• Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours 
• Best-in-class well-being programs
• Annual, no-cost health assessment program Blueprint for Wellness®
• healthyMINDS mental health program
• Vacation and Health/Flex Time
• 6 Holidays plus 1 "MyDay" off
• FinFit financial coaching and services
• 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
• Employee stock purchase plan
• Life and disability insurance, plus buy-up option
• Flexible Spending Accounts
• Annual incentive plans
• Matching gifts program
• Education assistance through MyQuest for Education
• Career advancement opportunities
• and so much more!

Duties and Responsibilities

•    Act as the primary Patient Services auditor and perform audits per the current corporate schedule for all Patient Service Centers (PSCs) and In-Office-Phlebotomy (IOP) sites. Review audit results and corrective actions. Ensure timely completion of all corrective actions. Report audit status to supervisors, managers, regional and corporate Quality.
•    Ensure that Patient Services is compliant with the current approved document control procedures.  Review and update Patient Services’ procedures, policies and other controlled documents (PPDs) per current review requirements.  Ensure all PPDs are current and aligned with testing laboratory, regional and national documents, and state or local regulations for Phlebotomy Scope of Practice. Ensure that all affected employees are trained before implementation of new and/or revised documents.
•    Ensure that PSCs are prepared for internal and external regulatory inspections/audits. Work with the local QA Manager, Corporate Quality Mentor and Lab Director to implement corrective action and submit proper audit responses.
•    Ensure that remedial actions are completed when issues are identified, and documented as required.
•    Assist managers through the remedial process and ensure that all corrective actions, remedial actions and replication process are completed within a timely fashion.
•    Review, analyze and prepare a monthly report for Problem Tracking/Customer Care database.  Make recommendations for process improvement and error reduction.
•    Monitor and review specimen labeling discrepancies/mismatches with supervisors weekly. Provide monthly report to Manager.
•    Review and analyze the monthly corporate Recollection Report. Report data and trends to supervisors and manager.  Make recommendations for process improvement and error reduction.  Presents metrics at QA meetings and provides end-of-year summaries for the Annual Quality Management Plan Assessments.
•    Direct/participate in Quality Improvement projects for PSCs. Identify areas in need of improvement and carry out process improvement projects.
•    Ensure that all records are maintained as required in accordance with the organization’s Compliance policies and the various regulatory agencies including temperature monitoring, centrifuge maintenance, eyewash checks, fire extinguishers, etc.  
•    Create training modules and assist with staff training, as needed, as it relates to compliance and quality measures.
•    Ensure employee competencies and job authorizations are completed per current approved procedures and documented for all pre and/or post analytical functions performed in the region.
•    Liaison between local Patient Services and the Clinical Laboratory staff regarding technical issues, new processes, regulatory issues and process improvement.  Attend meetings with technical and quality assurance staff

•    Liaison between the local Patient Services and corporate Patient Services.  Communicate with corporate Patient Services when clarification is needed, make recommendations for changes and corrections as applicable.  Review new procedures issued from corporate Patient Services for compliance with local regulations and suitability for local implementation.  Work with the local Medical Director to revise, adapt and implement new procedures and revisions.
•    Liaison with regional Environmental Health and Safety (EHS) to implement policies and protocols as needed. Ensure PSC Biohazard Waste Permits are renewed per local regulations. 
•    Liaison with regional Compliance Department to implement policies and protocols as needed. Provide required data and responses for compliance metrics and audits.
•    Assist with the development and maintenance of the Quality Programs for the Patient Service Centers in coordination with the Director of Patient Services, local Quality Assurance team, the Laboratory Director and other stakeholders.

Qualifications:

Education Required

Bachelor’s degree

Masters’ degree preferred

Certification Required

Current California Clinical Laboratory Scientist  License (for California), Medical Technologist License or Medical Laboratory Scientist License

Work Experience

Minimum three years technical experience

Other

• Previous Patient Services or Clinical Laboratory supervisory and/or Quality Assurance experience preferred, but not required.
• American Society for Quality (ASQ) certification useful, but not required.

General 

• Intermediate to advanced computer literacy plus excellent communication and written skills.
• Ability to identify problems, conduct investigations and analyze data, present resolutions and monitor solution effectivity.
• Ability to work with and lead cross-functional teams with a wide variety of education and expertise, such as local technical subject matter experts, senior leadership, supervisory groups, and front line employees.
• Ability to influence positive change and promote team collaboration.
• Effective training skills using a variety of modalities, such as lecture and hands-on methods.
• Other duties as assigned

Qualified applicants with arrest or conviction records will be considered for Employment in accordance with the following laws if applicable, the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act.
Quest believes that conviction records may have a direct, adverse, and negative relationship to the following job duties: accessing company property, information, assets, and products including sensitive information; accessing customer data or confidential information, and partnering and regularly working with or supervising other Quest employees and interacting with Quest customers.