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.

• Coordinate the Proficiency Testing Program (CAP and NYS) for the laboratory - maintain database 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 quality issues and ensure that revised and amended reports are 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:

BA/BS Degree in a Life Science or equivalent combination of education and experience preferred.