**Job Type:** Regular **Time Type:** Full time **Work Shift:** Day (United States of America) **FLSA Status:** Exempt **When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.** The Quality Assurance (QA) Specialist coordinates, monitors, and facilitates all Quality Assurance activities related to clinical or research lab. Responsible for implementing controls and reviewing results of processing patient care/testing to ensure that quality standards are met. In addition, the QA Specialist participates in the development, writing and implementation of processes, programs and standard operating procedures. **Job Description:** **Primary Responsibilities:** + Determines that SOPs exist for all procedures in the lab and ensures that all up-to-date procedures for process control of SOPs are available to all laboratory sections. Reviews and provides written approval of all standard operating procedures written for use in the Blood Bank. Maintains master list of critical SOPs and coordinate their annual review. (essential) + Ensures in the lab that validation principles applicable to the section or department's systems and processes exist and that adequate validation procedures have been performed. Review and provide written approval of all validation documentation. (essential) + Participates in the development, implementation, and administration Equipment Process Control procedures. Approves in writing all equipment documentation. (essential) + Error/Accident Reports, Complaints, and Adverse Reactions. Develops and implements procedures for the Occurrence Reporting Program. Participates in the administration of the principles of the Error Management Program; review quality procedures to ensure that all complaints are properly investigated. (essential) + Ensures that procedures are in place for thorough investigation and complete documentation of donor and recipient adverse reactions. Ensures that biological product deviations are reported to the FDA. Monitors the Lab Quality Mailbox. (essential) + Prepares for all site visits by Inspection and Accreditation Organizations by assessing all activities of the lab to ensure compliance with all standards and regulations. Conduct various audits to ensure that systems, processes and procedures are functioning properly. (essential) + Implements procedures to ensure that any lot discrepancies or failure of a lot or unit to meet its specifications are thoroughly investigated; design and approve in writing procedures to be followed to ensure that correct labels, labeling, and packaging material are used for all products and specimens. (essential) + Ensures removal from the inventory or tracking of unacceptable products, and when indicated, trace recipients of unacceptable products by initiating and keeping records of market withdrawals and recalls. Assist the Medical Directors in tracking all transfusion-transmitted disease and maintain and secure the records of these activities. (essential) + Reviews validation documentation of changes. Develops, implements, and administers process control procedures for system changes, design and diagram modifications, present documentation to the Medical Director for approval, obtain programming changes, debug the changes, validate the changes, and implement new or revised programs. (essential) + Participates in the development, writing, implementation and administration of the Training Program for the Lab. Provide training and assess competency. Review and provide written approval of documents for the lab. (essential) **Required Qualifications:** + Bachelor's degree in Life Sciences or Medical Technology required. + 3-5 years related work experience required. + Strong knowledge of laboratory accreditation requirements. + Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases. **Preferred Qualifications:** + Certifications in at least one of the following areas: ASCP, CIH, CSP or HEM. Experience in Transfusion Medicine. Strong organizational skills and the ability to integrate and synthesize new information quickly; including compilation of data into reports. **Competencies:** **Decision Making:** Ability to make decisions that are guided by precedents, policies and objectives. Regularly makes decisions and recommendations on issues affecting a department or functional area. **Problem Solving:** Ability to address problems that are highly varied, complex and often non-recurring, requiring staff input, innovative, creative, and Lean diagnostic techniques to resolve issues. **Independence of Action:** Ability to set goals and determines how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction. **Written Communications:** Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers. **Oral Communications:** Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers. **Knowledge:** Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations. **Team Work:** Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments. **Customer Service:** Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner. **Social/Environmental Requirements:** Work requires close attention to task for work to be accurately completed. Intermittent breaks during the work day do not compromise the work. Work is varied every day and the employee needs to be adaptable to respond to these changes and use independent judgment and manage priorities. No substantial exposure to adverse environmental conditions **Health Care Status:** NHCW: No patient contact.- _Health Care Worker Status may vary by department_ **Sensory Requirements:** Close work (paperwork, visual examination), Monitor Use, Visual monotony, Visual clarity <3 feet, Conversation, Monitoring Equipment, Telephone, Background Noise. **As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more (https://www.bilh.org/newsroom/bilh-to-require-covid-19-influenza-vaccines-for-all-clinicians-staff-by-oct-31) about this requirement.** **More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.** **Equal Opportunity** **Employer/Veterans/Disabled**