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Quality/Regulatory I Coord - Novi, MI in Novi, MI at Quest Diagnostics

Date Posted: 3/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Novi, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    3/11/2019

Job Description

Basic Purpose:
The Quality/Regulatory Coordinator I will ensure Health & Wellness events meet regulations and inspection readiness at all times.  Responsible for the maintaining records, field issue resolution, and wholesale/distribution center permitting.  In addition the coordinator will maintain responsibilities specializing in Immunizations and Re-credentialing, or Wellness Event Permitting. Duties are performed in compliance with all procedures, regulations and policies in adherence Federal, State, and County Health Department regulations. 

Duties and Responsibilities:

• Responsible for performing quality/regulatory duties in perspective area assigned such as creating electronic files, finger stick data review, staff licensure re-credentialing and notifying and/or permitting for Wholesale Distribution licensure. 

• Data entry of quality control (QC) information used to observe issues including bias, shift or trends in quality control data from finger stick tabulate.

• Review of QC and instrument performance. Verify reagents, Lot #s, ranges, temperature requirements, expiration and other manufacturer & state requirements for QC.

• Document corrective action requirements, report retraining to Field Specialists, and track training completion.

• Communication of QC failures to appropriate internal and external parties. Execute QC resolutions according to client or medical director responses.

• Perform all duties in compliance with standard operating procedures, regulations outlined in the Code of Federal Regulations (CFR) and other applicable federal, state and local laws.

• Perform other duties as required

Immunization and Re-credentialing Specialization:

• Monitor for changes in clinical staff credentials and/or demographics as they may trigger the need for additional credentialing. 

• Provides effective and professional customer service via telephone, written and face-to-face interactions with company representatives and government agencies seeking information regarding staff credentialing, and coordinates effectively with Human Resources, IT, clinical staff, and staffing department as needed.

• Ensures the confidentiality of all client-identifying information, personal staff information, and proprietary business information in accordance with State and Federal regulations, agency polices, and set procedures.

• Assist with research, review, and re-verification for applicable federal and state regulations pertaining to immunization products and protocols.

• Ensuring proper Standing Orders process is being followed.

• Tracking and monitoring of vaccine distribution and adhering to CDC, FDA, and State regulations for immunization procurement

• Develop, conduct and ensure staff at Distribution locations are trained in immunization policies and procedures.

• Performs tracking and monitoring of OSHA and Biomedical Waste related duties.

Event Permitting Specialization:

• Notify and/or submit applications for all Health & Wellness Events in accordance to state and county Health Department requirements.

• Tracking event & annual permit status’s to ensure permits are in place and distributed for Health & Wellness events.

• Communicate state regulations and training requirement protocol to branch offices and all other appropriate parties. 

• Collaborate with Quest Medical Directors and Quest Laboratories to ensure compliance requirements are met.

• Submitting and obtaining Biomedical Waste Permits required in applicable states.

• Monitor training documentation of field examiners when required to uphold specific permits and licensure.

Supervision Exercised:  N/A

Qualifications:
Education Preferred:  Bachelor’s degree or Associate degree or equivalent experience within Quality/Regulatory or other Health and Wellness related department

Work Experience: 1 year of experience in an administrative or customer service role preferred 
Other: Demonstrated ability to communicate effectively both internally and externally with all levels of professionals via conference call, email and face-to-face
Demonstrated ability to prioritize and manage multiple task
Demonstrated ability to produce required deliverables with appropriate level of detail and accurateness and meet established deadlines
Able to work independently and make sound decisions as needed
Proven ability to work collaboratively across multiple functions
Competent in MS office programs (Word, Excel, PowerPoint)