Coordinates Quality Assurance activities in the assigned testing department.
Supports compliance with required regulatory processes in accordance with company policy, state and federal requirements.
Supports inspection readiness at all times.
Essential Job Duties and Responsibilities
Supports compliance with all applicable regulatory agencies and company policies.
Coordinates compliance with applicable regulations through documentation, audits, and corrective action.
Performs preliminary review of all departmental quality records. Collaborates with management in the testing department to investigate and help resolve non-conformances.
Audits the training and competency program for assigned testing department. Provides training for staff in assigned department for Quality Assurances policies and procedures.
Coordinates departmental internal and external proficiency testing activities.
Supports compliance with document control policies for all procedures and related documents used in the assigned testing department's quality program.
Assists with internal and external audits. Performs audits in assigned department and other departments as directed.
Promotes continuous quality improvement by collaborating with management to implement standardization and process improvement.
Performs special projects as assigned.
Actively participates as a member of the Quality Improvement Team.
Physical Demands
None
Qualifications
Experience, Education, and Licensure
At least 6 years of progressive laboratory experience.
Bachelor's degree in medical technology or other life or physical sciences from an accredited college or university.
ASCP certification or eligible preferred.
Knowledge, Skills and Abilities
Demonstrates knowledge of current company policies and procedures.
Demonstrates knowledge of current local, state and federal requirements.
Demonstrates leadership skills through accountability, integrity, and collaboration in daily tasks.
Demonstrates initiative and strong problem solving skills.
Communicates with employees in a manner that creates an informed, positive environment.
Facilitates efforts to work with others in a way that promotes teamwork and change.
Projects a positive, professional demeanor.
Proficiency in computer skills using Windows based software (Word, Excel, etc.). Other computer skills such as statistical analysis and laboratory information system helpful.
