QA/QI Specialist
$76.9k - $86.1kDana–Farber Cancer Institute
The QA/QI Specialist is responsible for monitoring operations and developing and managing quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current and adhered to by staff in the assigned unit or department. Expected to understand and apply principles of quality management practices to the monitoring and improvement of the operations for the unit(s) assigned. Key areas of focus may include patient and staff safety, clinical laboratory, cell processing, donor blood product collections, tissue banking, clinical operations and other specified departmental procedures and policies as assigned. Plays key role in supporting preparation and on site support during site surveys and audits by regulatory agencies. Works with multidisciplinary teams and may be assigned to work under the direction of physician or nursing staff for assigned initiatives. Applying knowledge of area assigned, carries out monitoring, documentation review, data gathering and some limited data analysis, basic audits, and support for quality improvement initiatives. Supports multidisciplinary teams in developing and carrying out quality improvement initiatives as assigned. Located in Boston and the surrounding communities, Dana‑Farber Cancer Institute is a leader in life‑changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high‑risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
PRIMARY DUTIES AND RESPONSIBILITIES:
Applying significant knowledge of area assigned, carries out or leads monitoring efforts and populates dashboard and key indicator data sets Develops, supports, and/or leads quality improvement initiatives; develops approaches to linking quality improvement to outcomes reported through dashboard or key indicator data or surveys and observation studies Works with institutional leadership to develop improvement efforts Reviews documentation and assesses effectiveness of documentation review approaches; analyses causes and develops solutions for documentation failures Gathers data and/or develops research and data analysis projects Develops and carries out complex audits requiring content and operational knowledge of activity being audited Maintains employee records of training and credentialing as required by unit activity assigned and associated regulatory standards Can perform audits to ensure compliance against standards, regulations, procedures, policies, IND/IDE and clinical trials Perform trending and analyzing of data using appropriate quality and statistical tools. Assist in reporting data within and external to the department, institution, across institutions, and to governmental agencies Assist / develop training documentation, review/audit competency assessments and training documentation to ensure that employee record corresponds with tasks employee is performing CAPA – Assist with correction and preventative action plans based on audit findings, deviations and events. Plan follow up audits to assess if the desired effect / change was achievedKNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Maintain basic knowledge of applicable standards and regulations to ensure department / institution ongoing compliance with accreditation standards (FACT, JC) and inspection regulations (FDA, DPH, CMS, DOT) Outcome analysis - Review / interpret / report relevant information as assigned or to present to physician or other investigator Subject matter expertise – provide assistance in a given area of expertise (microbiology, immunohematology, cell processing, informatics, clinical operations etc) to help the department / program achieve its stated objectives and goals for the overall improvement of the program Strong Excel skills required.MINIMUM JOB QUALIFICATIONS:
The position requires a BS/BA degree in science, medical technology, or a related field. Candidates must have at least 5 years of experience in a relevant field, such as clinical laboratories, blood banks, clinical settings or the biologic/pharma industry.SUPERVISORY RESPONSIBILITIES:
Provides training and support to relevant staff (CMCF, KFBDC, Clinicians, etc) in areas of expertise. No direct reports.PATIENT CONTACT:
Limited contact with patients, donors and families, but extensive review of patient’s / donor’s medical records (adults and pediatrics). At Dana‑Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana‑Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status or other characteristics protected by law. EEO Poster Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity and based on the candidate’s relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA). $76,900.00 - $86,100.00 #J-18808-Ljbffr Dana-Farber Cancer Institute- Philips Iberica SAU is seeking a Quality Assurance Specialist for Device History Record in Cambridge, Massachusetts. This role is vital in ensuring compliance with regulatory and internal standards for medical device manufacturing. Responsibilities include reviewing records...SuggestedHourly payFull time
$69.91k - $90.88k
American Health Quality Association is seeking a Health Science Specialist (Quality Assurance) for the VA Boston Healthcare System. This role involves developing and maintaining quality assurance programs within clinical trials, ensuring compliance with regulatory standards...Suggested$72.78k - $96.07k
Catalent is looking for a qualified candidate for a pivotal role at their Chelsea, MA facility overseeing production activities and ensuring compliance with GMP standards. The position requires a bachelor's degree in a scientific discipline and at least 3-5 years of experience...SuggestedNight shift- A growing AI Data Services company is seeking a detail-oriented professional to review and generate high-quality bilingual content in Hebrew and English. This role involves creating prompts, evaluating AI responses, and ensuring model reliability. Candidates should possess...SuggestedRemote workFlexible hours
$48.01 per hour
...Massachusetts license in the category of Mammography and RT (R)(M) ARRT registered. Bachelor's degree preferred. Prior QC/QA program management or regulatory preparation skills highly preferred. Can this role accept experience in lieu of a degree?...SuggestedHourly payImmediate startRemote workRelocation packageMonday to FridayShift work- A leading AI research firm is seeking a detail-oriented Business Analyst to support evaluation and annotation workflows. The role involves performing evaluations, conducting fact-checking, and providing structured justifications for decisions. The ideal candidate should...Remote workFlexible hours
$64.9k - $81.1k
...at a time. To those who see AI as a driver of progress, come build the future together. The Crown Is Yours As a Risk and QA Innovation Specialist on the Marketing QA team, you’ll play a critical role in helping our Marketing organization navigate complex legal and regulatory...Full timeImmediate start$48.01 per hour
...addition, a valid Massachusetts license in the category of Mammography and RT (R)(M) ARRT registered. Bachelor's degree preferred. Prior QC/QA program management or regulatory preparation skills highly preferred. Can this role accept experience in lieu of a degree? No...Hourly payImmediate startRemote workRelocation packageShift work$45.25 - $67.74 per hour
...applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary The Quality Assurance Specialist provides enterprise-wide operational oversight for modality performance across the Mass General Brigham (MGB) Radiolog Qualifications...Hourly payRemote workShift work$50 - $60 per hour
A leading AI healthcare organization is seeking an Oncologist to join their remote team. In this role, you will train AI models by providing diverse healthcare-related problems and evaluate their logic and outputs. Candidates should have a medical degree and fluency in...Hourly payRemote workFlexible hours- ...The Quality Assurance Specialist provides enterprise-wide operational oversight for modality performance across the Mass General Brigham (MGB) Radiolog Education Associate's Degree Health Sciences required or Bachelor's Degree Health Sciences preferred...
$13 - $23 per hour
...Job Description The Drupal QA resource will provide quality assurance support for web pages prior to publishing, serving as a fresh set of eyes to ensure accuracy, consistency, and a bug‑free user experience prior to go‑live. This role focuses on validating that content...Part time10 hours per weekDay shift$43 - $45 per hour
...Job Title: Quality Assurance Associate Job Description This role involves providing support for QA issues within the manufacturing suite and mitigating gaps and risks associated with all quality and GMP processes. The position requires running investigations for...Contract workTemporary work$109.15k - $126.85k
...Senior QA Specialist, RLT Manufacturing Operations We are seeking an experienced Senior QA Specialist, RLT Manufacturing Operations to join Mariana's Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals. The Senior QA Specialist for...- Fagron Tech in Canton, Massachusetts is seeking a Quality Assurance Specialist to oversee quality assurance activities in cGMP manufacturing. Responsibilities include executing Quality Assurance tasks, supporting Batch Records, and ensuring compliance with quality standards...
$24.51 - $34.53 per hour
Quality Assurance Specialist - Device History Record (DHR) Job Description Quality Assurance Specialist - Device History Record This individual ensures Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the...Hourly payFull timeWork experience placementWork at officeRemote workWork visaRelocation package- ...Quality Assurance Specialist Assesses compliance with cGMP regulations on difficult and complex technical issues. Perform batch record... ...environment is required. Preferred: QA experience within cGMP API manufacturing is highly preferred....Work at officeFlexible hoursWeekend work
- ...QA Documentation Associate A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception...
$50 - $60 per hour
A leading AI company in the United States seeks a VC Associate to enhance AI training for finance professionals. This role offers flexible remote work and the ability to set your own schedule, making it suitable for full-time, part-time, or independent work. Candidates ...Hourly payFull timePart timeRemote workFlexible hours$55k - $151.47k
Specialty/Competency: Data Science Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 20% At PwC, our people in data and analytics engineering focus on leveraging advanced technologies and techniques to design and develop robust...Full timeWork experience placementH1bRemote work$19 - $23 per hour
Rockville Loop is seeking a Part-Time Inventory Control Associate based in Malden, MA for Amazon. In this role, you will ensure the accuracy of inventory and prevent customer order delays through systematic checks and audits. Ideal candidates should possess strong analytical...Hourly payPart time$123k - $166k
...Senior Quality Assurance Specialist Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines... ...Quality Assurance Specialist will provide Quality Assurance (QA) oversight and support to Manufacturing, Quality Control, and Process...Temporary workWork experience placementSummer workLocal area$50k - $60k
...Service TM business model. Position Summary: Discovery is looking for a talented and passionate Quality Assurance Associate (QA Associate) to join our team. The Quality Associate contributes to our mission by assisting in the development and maintenance of the...Monday to Friday$70k
Quality Assurance Position An entry level quality assurance position. Responsibilities include, but are not limited to: assisting with the organization and implementation of training for employees; assisting with SOP/Protocol drafting/editing/routing; creation and completion...Contract workRelocationShift work- ...Sr. Quality Assurance Specialist A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri... ...The Quality Assurance Professional will work in the Internal QA team of company's Human Genetic Therapies Quality Assurance Department...
- ...Quality Verification Specialist And Data Entry We are seeking a highly detail-oriented and organized individual to join our team as a Data Entry and Quality Verification Specialist. In this role, you will be responsible for provider data entry, fee schedule entry,...Work at office
$80k - $96k
About the Job The Quality Assurance Specialist is an intermediate level professional position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintained...Local area$55 - $65 per hour
...Job Description The operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including...Contract workTemporary workWork at office$1,300 per day
Pharma Quality Auditor For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across...Contract workLocal areaRemote workWorldwide$55 - $65 per hour
...Job Description The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports new/existing project initiatives...Contract workTemporary workFor contractors
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QA/QI Specialist. Be the first to apply!

