Quality Assurance Manager
Quality Assurance Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Title: Quality Assurance Manager
Location: Silver Spring MD 20904
Job Type: Fulltime
Job Summary:
The Quality Assurance (QA) Manager is responsible for the laboratory quality safety and training programs and manages staff within the QA Department. The QA Manager ensures product safety product quality compliance with all relevant regulations accreditations certifications and customer expectations are met. Working cross-functionally they are drivers of continuous improvement risk mitigation and proactive solutions are deployed to ensure alignment with the companys mission and values. Success is measured in terms of the frequency and scale of product and service quality organizational issues as well as business process effectiveness.
Minimum Qualifications:
Education:
- Bachelors degree in chemical physical biological or clinical laboratory science or medical technology
Experience:
- 5 years of experience with high complexity clinical laboratory testing operating under CLIA/CAP and NYS regulatory requirements
- 3 years of experience in a Quality Assurance/Management role
- 2 years of laboratory management experience with direct reports
- Strong team management skills; experienced in cross-functional collaboration and project management
- Prior administrative experience with MediaLab
Preferred Qualifications:
Education:
- Masters degree in chemical physical biological clinical laboratory science medical technology or regulatory affairs
Experience:
- 10 years of experience with high complexity clinical laboratory testing operating under CLIA/CAP NYS ISO regulatory accreditation requirements
- Experience with immunohistochemistry anatomical pathology biochemical and molecular clinical testing
- 5 years of Quality Assurance/Management experience in a high complexity laboratory under CLIA/CAP NYS and ISO regulatory and accreditation/certification requirements
- 5 years of laboratory management experience with direct reports
- Strong team management skills; experienced in cross-functional collaboration and project management
- Prior administrative experience with MediaLab
Certification:
- MLS CLS certification or equivalent
- ASQ certified
- Six Sigma certified
Duties & Responsibilities:
- Ensures continuous laboratory licensure and accreditations/certifications through the timely submission of required documentation.
- Maintains knowledge of laboratory regulatory requirements to include accrediting/certifying bodies federal state and local requirements and provides on-site consultation on quality and/or regulatory issues.
- Meets regularly with department leaders laboratory managers/supervisors and Medical Directors to implement and monitor the laboratory quality management quality improvement programs.
- Assist departmental managers and medical directors in implementing and maintaining competency and continuing education for staff.
- Provides education to staff regarding laboratory quality management programs and good laboratory practices.
- Continuously monitoring quality control and quality assurance is compliant with corporate and regulatory standards
- Compiles analyzes and reviews with departmental leaders data related to complaints nonconforming events and CAPAs to resolve quality deviations to maintain client and patient expectations of quality.
- Continuously monitors and ensures corporate and personnel adherence to company safety policies procedures and federal state and county regulatory requirements.
- Compiles Quality Indicator data for routine analysis and corrective action (when applicable). Quality Indicators are presented and evaluated during routine management reviews.
- Oversees management of electronic quality management system (eQMS) including the maintenance and application of training matrices and document control retention and archival associated activities.
- Conducts internal audits and hosts external client and regulatory audits and inspections. Includes communication and coordination with auditors/inspectors laboratory SME pre-audit/inspection preparation activities and submission of post-audit/inspection responses.
- Provides SME guidance and participates in assay development and corporate initiative projects.
- Oversight of and provides SME guidance to ensure assay validation and verification compliance to regulatory and corporate requirements prior to implementation and associated change control activities.
- Provides leadership and manages assigned department make decisions solve problems develop procedures conducts and attends meetings.
- Provides Quality guidance and support in the qualification and onboarding of new employees.
- Assist Human Resources in employee development tracks for clinical career paths within the company.
- Promotes the company Mission Values and Quality Policy
- Coordinate the maintenance development and implementation of departmental policies and procedures.
- Support and participate in special company-wide projects
- Must be familiar with and abide by the Corporate Compliance Program and all corporate policies including the Privacy and Security policies.
- Performs other job-related duties as assigned
Physical Demands and Work Environment:
- Frequently required to sit stand talk and hear utilize finger and hand dexterity
- Frequently required to utilize visual acuity to operate equipment read technical information and/or use a keyboard
- Occasionally exposed to bloodborne and airborne pathogens or infectious materials
- Will require occasional travel within the region to patient care centers < 20% of time
Employment Type
Full Time
