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Spec, Quality Assurance

Iconma

Clifton, NJ

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JOB DETAILS
SALARY
$30.11–$54.16 Per Hour
SKILLS
Accreditation Standards, Analysis Skills, Best Practices, Business Processes, CAP - Certification Authorization Professional, Change Management, Clinical Laboratory, Communication Skills, Computer Skills, Corrective Action, Federal Laws and Regulations, Health Plan, Interpersonal Skills, Laboratory, Laboratory Management, Laboratory Operations, Licensing, Maintain Compliance, Matrix Management, Medical Research, Multitasking, Organizational Skills, Pathology, Physical Chemistry, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Management, Quality Monitoring, Regulations, Regulatory Compliance, Specimen Collection, Specimens/Samples, Standard Operating Procedures (SOP), State Laws and Regulations, Surveillance, Technical Leadership, Testing, University/School Regulations, Writing Skills
LOCATION
Clifton, NJ
POSTED
9 days ago
Our client, is a Medical Research company, is looking for a Spec, Quality Assurance for their Clifton, NJ location.
 
Responsibilities:
  • Support and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission.
Licensing and Accreditation:
  • Support the internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and client standards.
  • Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards.
Proficiency Testing:
  • Assist and ensure enrollment and participation in proficiency testing for each test to include Corrective Action when necessary.
  • Coordinate the Validity Check program and Blind Samples resubmission program, if applicable.
  • Assist in maintaining a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process.
Quality Assurance/Quality:
  • Improvement Support and assistance in monthly Quality Assurance (QA) meetings. Support each department's comprehensive Quality Improvement (QI) plan. Assist in maintaining and monitoring Quality Assurance specific quality indicators.
  • Facilitate the preparation, distribution and review of the QA Manual.
  • Support the Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by National Quality Assurance. Quality Assurance Initiatives
  • Assist in the prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP).
  • Assist in the complete tracking of revised reports in compliance with the SOP.
  • Assist in any other duties as assigned by the Technical Manager.
 
Requirements:
  • Qualification as General Laboratory Supervisor as defined by CLIA '88required
  • At least three years employment in a laboratory setting required
  • Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
  • Strong interpersonal communication skills required
  • Demonstrated strong writing and composition skills required
  • Understands clinical laboratory operations required
  • Able to effect Quality Improvement through problem solving skills and knowledge of quality tools required
  • Able to manage change required Organization skills required Project management skills required
  • Analytical skills required
  • Technical skills required
  • Computer skills required
  • Able to function in a matrix organization desirable
  • Multi-tasking skills desirable
  • Demonstrated success in motivating team members to reach objectives desirable
  • Bachelor's Degree - Chemical, physical, biological or clinical laboratory science or medical technology - required
  • Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88 is required
 
Why Should You Apply?

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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