Specialist, Quality Assurance

Contribute to the overall QA Program of the laboratory. Responsible for licensure, accreditation and inspection of the laboratory. Accountable for the internal and external quality assurance programs. 

Location: Southfield, MI

• Manage Proficiency Testing Program (CAP and NYS) for the laboratory - maintain data base and produce monthly summaries. 


• Manage the Document Control System. Support compliance with document control policies for all procedures and related documents. 


• Assist in the prompt and complete reporting of Reportable Quality Issues and Revised and Amended Reports in compliance with the SOP. 


• Conduct internal audits to ensure laboratory is inspection ready at all times. 


• Assist with external audits. 


• Review protocols and make recommendations to enhance QA Program.  


• Coordinate compliance with applicable regulations through documentation, audits, and corrective action.  


• Perform reviews of departmental quality records.  Collaborate with management in the testing department to investigate and resolve nonconformances.  


• Audit training and competency program.  


• Promote continuous quality improvement by collaborating with management to implement standardization and process improvement.  


• Perform special projects as assigned. 


• Perform other duties as assigned to meet the business needs or customer requirements. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position. 

Required Work Experience:  

Minimum two (2) to three (3) years technical laboratory experience.  

Preferred Work Experience:  

Previous experience with Quality Assurance and laboratory regulations preferred.  

Physical and Mental Requirements:  

• The normal performance of duties may require lifting and carrying objects: Objects 1 to 10 pounds are lifted and carried frequently; objects 11 to 25 pounds are lifted and carried occasionally; objects 36 to 50 pounds are seldom lifted or carried and objects over 50 pounds are not to be lifted or carried without assistance. 
• Ability to sit or stand for long periods of time. 

Knowledge:  

• Basic theoretical and operational job knowledge in quality assurance and laboratory operations. 
• Knowledge of organizational/departmental policies and procedures. 

Skills:  

• Demonstrate leadership skills through accountability, integrity, and collaboration in daily tasks. 
• Excellent interpersonal and communication skills (oral and written) necessary to effectively interact with all levels of staff. 
• Project a positive, professional demeanor. 
• Communicate with employees in a manner that creates an informed, positive environment. 
• Facilitate efforts to work with others in a way that promotes teamwork and change. 
• Must be detail-oriented, have the ability to work independently, establish work priorities and to handle several tasks simultaneously. 
• Strong organizational and prioritization skills. 
• Proven problem-solving skills with the ability to develop appropriate resolutions. 
• Proficiency in Microsoft Office (Word, Excel and Outlook) and Laboratory Information Systems. 

Education

• Bachelor’s Degree BA/BS Degree in a Life Science or equivalent combination of education and experience. (Required)

Licenses and Certifications

• ASCP Certification (Preferred)