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Quality Assurance Specialist I
2 months ago
JOB DESCRIPTION
Quality Assurance Analyst
Department:
Lab Support
FLSA Status:
Exempt
Reports To:
Director of Quality
Experience:
Typically requires 2-4 years of relevant experience
Job Summary:
- The Quality Assurance Analyst plays a vital role within the Quality Assurance department, assisting in the planning, execution, and oversight of the Quality Management System (QMS). This position is responsible for ensuring that the laboratory adheres to quality and productivity benchmarks while complying with all regulatory and safety standards as mandated by relevant accrediting bodies.
Key Responsibilities:
- Maintains regulatory readiness by managing procedure manuals, training documentation, validation records, personnel files, and quality documentation in accordance with established standards.
- Updates procedural manuals as necessary within laboratory operations.
- Participates in laboratory audits and accreditation assessments as required by management.
- Serves as a communication bridge between various laboratory departments and the QA team to address quality-related inquiries, implement policies, and uphold quality objectives.
- Ensures the integrity of the Document Control System as per organizational standards.
- Implements minor adjustments to controlled documents as directed.
- Verifies that all laboratory equipment is properly maintained, inspected, and calibrated.
- Keeps detailed records of service agreements and maintenance logs.
- Conducts routine verification of laboratory documentation, including monitoring environmental conditions.
Knowledge and Skills:
- Maintains up-to-date knowledge of specimen collection protocols, including preparation, labeling, handling, preservation, processing, transportation, and storage.
- Gathers QA data to support the development of monthly and annual Quality Reports, establishing effective systems for monitoring accuracy and data quality.
- Manages contact information for laboratory personnel.
- Conducts QA procedures to monitor performance metrics and promptly informs management of any issues, collaborating on remediation strategies.
- Provides orientation and training for new hires and existing staff as needed.
- Participates in various committees as required.
- Accepts delegated responsibilities from the QA Supervisor or Director as appropriate.
- Maintains necessary licensures and engages in continuing education, ensuring compliance among staff.
- Contributes to the Safety and QA/PI Committee, attending meetings and implementing necessary changes.
Collaborative Duties:
Inspections/Audits:
- Coordinates pre-inspection evaluations and responses with laboratory management and staff to ensure compliance with all accrediting agencies.
Quality and Safety Programs:
- Collaborates with QA and Safety Supervisors to implement necessary changes during committee meetings.
- Assists in the development and ongoing management of quality initiatives within the laboratory.
- Reviews monthly performance metrics and aids in corrective actions to maintain compliance with established goals.
Process Improvement:
- Evaluates and supports lean initiatives aimed at enhancing laboratory processes to ensure quality care is delivered efficiently.
Qualifications:
Education:
- Bachelor’s degree required.
Competencies:
- Strong verbal and written communication skills.
- Proficient in creating and delivering presentations to diverse audiences.
Technical Skills:
- Moderate to advanced proficiency in Microsoft Office Suite and Adobe Acrobat.
- Ability to analyze and interpret statistical data for validation and correlation purposes.
- Quick adaptability to proprietary software systems.
- Willingness to travel occasionally.
Experience:
- Preferred 2 years of clinical laboratory experience.
Certifications:
- N/A