Specialist, Quality Assurance

Responsibilities

• 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.

Qualifications

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.

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 Sciences preferred. Equivalent combination of education and experience (considered).

Licenses and Certifications: ASCP Certification (Preferred).