Quality Regulatory Specialist

Quality Regulatory Specialist - Baltimore MD Monday to Friday 8:00 AM to 4:30 PM

Pay range: $26.91 - $40.37 / hour

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!

Ensure that products and services are delivered with the highest level of quality and regulatory compliance to deliver the best experience for our customers (employers resellers and health plans) and participants.

• Notify and/or submit permit requests at the state and county level
• Ensure all EPH events are properly licensed at the federal state and county level
• Manage the annual proficiency testing process
• Perform external and internal audits including but not limited to training and credentialing audits of the provider network
• When issues are identified whether through audits or inspections etc. conduct corresponding investigation and complete corrective action documentation related to department protocols to ensure compliance with all applicable regulatory standards
• Regularly conduct research of federal/state/county regulations and take appropriate steps to ensure EPH is in compliance; work with the Regulatory Affairs Manager to ensure affected departments are notified
• Assist with ensuring providers in the field are appropriately managing the vaccine in their possession. This requires being available to take calls from providers who require assistance with this process
• Participate in pre/post event activities process review strategy and planning; look for opportunities for continuous improvement
• Assist with review of department processes and Standard Operating Procedures (SOP) to ensure accurate reflection of current processes; update SOPs as needed
• Utilize QMS tools to implement process improvement within the department
• Provide support as needed to other lines of business within the Diagnostic Services Business Units
• Perform other duties as required
• Perform special projects as assigned.

Required Work Experience:

• Minimum 1-2 years of experience in a regulatory health & wellness health administration pharmaceutical or laboratory setting

Physical and Mental Requirements:

• Sitting for long periods of time; ability to focus for long periods of time

Knowledge:

• Demonstrated ability to collaborate across work groups
• Ability to manage multiple projects and priorities and deliver on tight deadlines
• Demonstrated ability to communicate effectively both internally and externally with all levels of professionals via conference call email and face-to-face

Skills:

• Proficient in Microsoft Word Excel PowerPoint
• Strong presentation skills

Education

• Bachelors Degree (Required)