The QA/QC Director oversees the development, implementation, and maintenance of quality systems ensuring compliance with all relevant regulatory standards. This position ensures that effective and current quality systems are in place and adhered by all staff. This position is also responsible for the oversight and/or review of quality control data such as quality records, control charts, calibration records, documentation of corrective actions and other QA/QC data.
– Leads the QA/QC functions to ensure products, processes and systems meet required quality standards.
– Is responsible for overseeing that all aspects of company operations comply with CLIA, CAP, COLA, OSHA, FDA and other regulatory agencies requirements and current industry practices.
– Is responsible for strengthening quality culture of the organization, coaching employees on investigation, root cause analysis, CAPA (corrective action plans) implementation, and risk management.
– Represents company during CLIA, CAP, COLA, OSHA, in-house visit, as well as other agency contacts as appropriate.
– Analyze, develop, implement and audit policies and procedures for applicability and compliance to regulations.
– Assist in the development, revision, and implementation of Standard Operating Procedures for the laboratory pertaining to safety, work hazards, and equipment.
– Responsible for laboratory’s quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs.
– Responsible for quality control daily operations to include stability testing, QC inspections and audits, QC documentation.
– Monitor, Inspect, train and complete reports on all quality related activities of products to and from staff.
– Perform, document, and track inspections.
– Evaluates company compliance with federal and safety regulations to reduce accidents and workplace injuries.
– Guide and mentor staff regarding compliance initiatives and procedures.
– Works cross-functionally within company and with external partners.
– Participate in the development of information databases to support quality system infrastructure.
– Evaluate quality data, prepare periodic reports to monitor trends, and report to management to ensure the Company’s continuous improvement efforts are on track.
– Review and approve reports and other documentation prepared by QA and QC for regulatory submissions/ inspections.
– Act as primary quality team member for projects and product teams, providing counsel, training, and interpretation of FDA and other applicable regulations to Company personnel.
– Participate in risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.
– Business Acumen
– Critical Evaluation
– Ethical Practice
– Attention to Detail
This position manages all employees that report to the DQA/QC per the organizational chart and is responsible for the performance management and hiring of the employees within that department.
his job operates in a professional office environment. This role routinely uses standard office equipment such as computers and phones.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is regularly required to talk and hear. This position requires the ability to occasionally lift office products and supplies, up to 30 pounds, standing and/ or walking continuously. There may me long periods of sitting involved. Infrequent exposure to hazards such as dust, fumes, or extreme temperatures, airborne or bloodborne pathogens, or allergens. Exposure to UV lights while some equipment is in use in the labs. Must have the ability to distinguish colors and perceive relative distances between objects. Online color-blind test is required.
Position Type/Expected Hours of Work:
This is a full-time position, and business hours currently are Monday through Friday, 8:00 a.m. to 5:00 p.m. Business hours will change as the company grows and will be disclosed at that time. Longer hours, evenings and weekend work will be necessary frequently.
Bachelor's Degree or higher in Biology or related field.
– Strong interpersonal skills, ability to communicate and manage well at all levels of the organization and with staff at remote locations essential. – Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
– High level of integrity and dependability with a strong sense of urgency and results-orientation.
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 16 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities. If at any time during the application process, you need an accommodation, please contact email@example.com for assistance.
Lighthouse Lab Services | 800-838-0602
#JY Job ID: 13147