Quality assurance specialist jobs in Fall River, MA - 419 jobs

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Testing Lead
Guidehouse 3.7
Quality assurance specialist job in Boston, MA
Job Family: Technology Consulting Travel Required: Up to 25% Clearance Required: None What You Will Do: The Testing Lead will serve as the overall owner of the testing program for the Commonwealth of Massachusetts' statewide Oracle Health (Cerner) EHR implementation. This role is responsible for designing, executing, and validating a comprehensive testing strategy that spans all phases of the implementation lifecycle, including unit, system, integration, regression, and user acceptance testing. The Testing Lead will ensure that all workflows-clinical, financial, operational, and technical-are validated for safety, reliability, and compliance across DPH hospitals, DMH facilities, SOPS, and community-based services. Key Responsibilities Testing Strategy and Governance Develop and maintain the Master Test Plan, including scope, schedule, entry/exit criteria, traceability, and risk posture. Chair the Testing Governance Committee, escalating risks, defects, and go/no-go recommendations to the Steering Committee. Establish consistent application of methodology across all facilities and testing events. Provide executive-level reporting to EOHHS leadership on readiness, defect posture, and overall progress. Testing Execution and Oversight Lead all testing events including: Unit Testing: Validate build objects (orders, flowsheets, dictionaries, charge codes). Build Quality Audit (BQA): Confirm configuration accuracy and compliance with Oracle Health standards. System Testing: Validate end-to-end workflows within facilities. Integration Testing: Confirm HL7/FHIR message integrity across labs, imaging, MIIS, PBM claims, and SOPS Meta. Security Testing: Validate role-based access, HIPAA, and 42 CFR Part 2 compliance. Accessibility Testing: Confirm WCAG 2.1 AA standards for behavioral health and vulnerable populations. Charge and Claims Testing: Validate financial workflows and payer adjudication. Parallel Revenue Cycle Testing: Reconcile Oracle Health Patient Accounting with legacy MEDITECH systems. Data Migration Testing: Confirm completeness and accuracy of migrated data. Device Testing: Validate integration of bedside and ancillary devices. Performance and Stress Testing: Confirm system responsiveness and resilience. User Acceptance Testing (UAT): Validate real-world workflows with EOHHS super users. Post-Live Smoke Testing: Confirm core functions are stable immediately after cutover. Regression Testing: Ensure upgrades and patches do not disrupt validated workflows. Tools and Automation Manage automation frameworks using Oracle Health Test Studio, Tricentis Tosca, and interface replay harnesses. Prioritize automation for repetitive workflows (e.g., admit → order → MAR → charge) to reduce burden on state staff. Maintain defect tracking in Jira/Confluence, with dashboards for aging, velocity, and closure trends. Use Smartsheet and Power BI for readiness dashboards and reporting. Environment and Data Management Maintain stable, synchronized testing environments across Waves 1 and 2. Manage test data creation, de-identification, and seeding. Coordinate with Oracle Health on environment refresh cycles and defect fix migrations. Stakeholder Engagement and Collaboration Collaborate with Domain Test Managers, Defect Manager, Automation Lead, and EOHHS champions. Facilitate daily stand-ups, defect triage sessions, and readiness reviews. Ensure EOHHS staff are engaged as validators, not burdened as primary testers. Document all testing decisions, results, and evidence in the Oracle Project Portal. Organizational Impact and Communication Leads cross-functional testing teams across clinical, financial, and technical domains. Communicates complex testing strategies to stakeholders at all levels. Ensures alignment with Commonwealth's enterprise architecture and governance standards. Innovation and Complexity Designs scalable, compliant, and resilient testing architecture across diverse care settings. Navigates complex legacy environments and fragmented workflows. Applies structured, repeatable methodologies for high-risk testing domains. Leadership and Talent Management Manages domain test managers, automation engineers, defect analysts, and environment coordinators. Provides mentorship, performance feedback, and escalation support across all testing workstreams. Coordinates with PMO, Technical Lead, and Functional Leads to ensure delivery milestones are met. What You Will Need: Minimum 10 years of experience in healthcare IT testing, with at least 5 years in leadership roles. Proven experience with Oracle Health Millennium and RevElate testing frameworks. Deep understanding of EHR testing best practices, including parallel revenue cycle testing, EMPI validation, and integrated testing. Experience testing in public sector environments, including DPH, DMH, and SOPS workflows. Familiarity with HL7/FHIR standards, device integration, and interface validation. Strong knowledge of compliance testing (HIPAA, 42 CFR Part 2, ADA/Section 508). Expertise in testing governance, defect management, and automation tools. Excellent communication, stakeholder engagement, and documentation skills. What Would Be Nice To Have: Certifications in ISTQB, HIMSS, or Oracle Health testing tools. Experience with federal/state EHR implementations, including VA or DoD projects. Familiarity with Oracle Cloud Infrastructure (OCI) and hybrid hosting models. Experience with behavioral health, correctional, and long-term care testing scenarios. The annual salary range for this position is $130,000.00-$216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs. What We Offer: Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: Medical, Rx, Dental & Vision Insurance Personal and Family Sick Time & Company Paid Holidays Position may be eligible for a discretionary variable incentive bonus Parental Leave and Adoption Assistance 401(k) Retirement Plan Basic Life & Supplemental Life Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts Short-Term & Long-Term Disability Student Loan PayDown Tuition Reimbursement, Personal Development & Learning Opportunities Skills Development & Certifications Employee Referral Program Corporate Sponsored Events & Community Outreach Emergency Back-Up Childcare Program Mobility Stipend About Guidehouse Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at ************** or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or ************************. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process. If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact *************************. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties. Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.
$130k-216k yearly Auto-Apply 1d ago

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Quality Assurance Specialist 21CFR GMP
Top Prospect Group
Quality assurance specialist job in Fall River, MA
Please note our client does not Sponsor Job Role: IT-QA Work Hours: General: 8:00AM - 5:00PM (May vary based on business needs) Reports To: Site Quality Assurance Head Salary Range: $67,000 - $95,000 - PURPOSE The purpose of the IT - QA Associate position is to accurately review the chronological record of Laboratory Instrument/Equipment electronic data related activities that provides documented evidence of relevant details of specific events. JOB DESCRIPTION The IT- QA Associate position is an individual contributor role and a member of the Pharmaceuticals Quality Team. The position monitors changes to electronic records, alterations in critical parameters or any other actions that could impact product quality. This position reports to the Site Quality Head. The job duties for this position include but are not limited to the following: Function as SME for IT related activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21CFR, Part 11 requirements. Conduct regular audits of the audit trail to identify any irregularities or potential issues. Additionally, routinely review and analyze the data to proactively address any emerging trends or areas for improvement. Provide comprehensive training to employees involved in the analytical laboratory related activities as well as manufacturing process who are entitled to use digital platforms for execution of GMP/GLP activities. Ensure that users understand the importance of audit trail integrity and data integrity and their role in maintaining accurate and reliable records and adhering to cGMP compliance. Provide support for investigation and implementation of CAPA related to such investigation. EDUCATION AND EXPERIENCE QUALIFICATIONS B.Sc. in a scientific discipline related to the pharmaceutical industry (Biology, Chemistry, Pharmacology, Biochemistry, etc). Basic knowledge and Industry experience of Quality System relevant to electronic records storage, retrieval, archival and audit of electronic data is must. Minimum of two (2) years' experience in a quality assurance in a GMP environment specific Quality Control Laboratory and Manufacturing operations in a pharmaceutical manufacturing organization. Experience in MDI or DPI dosage form manufacturing preferred. KNOWLEDGE, SKILLS, AND ABILITIES Candidates must have an aptitude for quantitative problem-solving or advanced analytics. Ability to multitask efficiently, prioritize quickly, and manage time effectively. Candidates must have experience in writing and executing performance tests. Database and computer skills; talent for analyzing and visualizing complex data. Advanced proficiency with Microsoft Excel. Must have current Good Manufacturing Practices (cGMP) knowledge. Must have strong attention-to-detail. Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed. Must have strong organization and communication skills (written, verbal, and presentation). Must be detail-oriented with the ability to prioritize tasks with strict deadlines.
$67k-95k yearly 1d ago
Quality Systems & Investigations Specialist
JMD Technologies Inc.
Quality assurance specialist job in Boston, MA
Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.
$50-58 hourly 3d ago
US/LATAM Spanish LQL Linguistic Quality Lead
Csoft International
Quality assurance specialist job in Boston, MA
Schedule: Mon-Fri (4 days in office required, 1 day optional remote) Compensation: Competitive Salary + Benefits We are a fast-growing AI language technology company seeking a US/LATAM Spanish Linguistic Quality Lead (LQL) to join our AI-focused language team on a mission to build the next generation of operational models. This is a unique opportunity for someone passionate about languages and technology, with the drive to shape the future of AI-powered communication in medical and life sciences translation. What You'll Do Lead linguistic quality assurance for US/LATAM Spanish, with a strong focus on medical device manuals, pharmaceutical content, and other regulated life sciences materials. Train large language models (LLMs) with Spanish linguistic data to enhance AI-driven translation, QA, and automation workflows. Translate, review, and edit Spanish content in active projects, ensuring accuracy, clarity, and regulatory compliance. Recruit, onboard, and manage Spanish linguistic resources (translators, editors, interpreters, interviewers) within our global network. Support project execution, ensuring linguistic excellence and cultural relevance across deliverables. Collaborate with other LQLs to drive workflow improvements and innovation, helping design future operational models. Partner with cross-functional teams at the intersection of language, life sciences, and AI. What We're Looking For Native proficiency in US/LATAM Spanish, with strong command of English. Ideal for your graduates with Spanish linguistic background. Familiarity with CAT tools (e.g., Phrase, Trados, MemoQ, XTM) is a plus but not required. Forward-thinking, creative, and energetic, with a willingness to take on challenges and think outside the box. Diligent, dependable, and committed to quality and continuous improvement. Strong organizational, communication, and problem-solving skills. Ability to work collaboratively with other LQLs, engineers, and project teams in a fast-paced, innovative environment. Work authorization in the U.S. is required. What We Offer Full-time role: Monday-Friday, with 4 days in-office and 1 day optional remote. Competitive salary + paid holidays, sick/personal days, and professional development opportunities. A modern office in Boston's Financial District. The chance to contribute to an AI-driven language team pioneering future business and operational models. A dynamic, entrepreneurial environment where your ideas and contributions have direct impact. This is an exciting role for someone passionate about Spanish language and culture, eager to explore AI-powered translation and linguistic innovation, and motivated to grow with a company shaping the future of language operations in medical and life sciences. How to Apply: Please send your CV to **********************
$88k-131k yearly est. 5d ago
Quality Systems Specialist
Advantage Technical
Quality assurance specialist job in Waltham, MA
Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr
$40-50 hourly 5d ago
Associate, Quality Operations QA
Talentburst, An Inc. 5000 Company 4.0
Quality assurance specialist job in Norton, MA
Industry: Pharmaceuticals Title: Associate, Quality Operations QA Duration: 09 months contract (+Possibility of extension) Onsite with 1x per week flexibility as needed. About the Role The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards. The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness. Key Responsibilities Provide raw material support, including review/approval of incoming material documentation and release for GMP use. Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities. Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents. Generate and maintain Quality-related SOPs and controlled forms. Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements. Review and approve QC laboratory qualification documents, including equipment qualification. Perform executed batch record review and approval to ensure accuracy and compliance. Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system. Support partner audits and regulatory inspections, including document retrieval and subject matter input. Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance. Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence. Qualification/Skills Bachelor's degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience. 2-4 years of GMP experience in Quality, Manufacturing, or QC. Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices. Strong attention to detail, organizational skills, and the ability to communicate effectively across teams. Experience with quality systems (e.g., Veeva, SAP) is a plus.
$57k-71k yearly est. 2d ago
Quality Assurance Manager - Food Safety
LSG Sky Chefs 4.0
Quality assurance specialist job in Boston, MA
Job Title: Quality Assurance Manager - Food Safety Salary Range: $90 000.00 About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Our team members are the heart and soul of our success, consistently delivering exceptional culinary experiences and outstanding service to our clients and their passengers across North and Latin America. Role Purpose Statement Ensure the food meets the standards set by regulatory health authorities and the company. The job incumbent is responsible for the implementation, auditing, assessing and training of food safety and quality management systems within the responsible Customer Service Center (CSC). Responsible for the development, deployment, implementation, and on-going execution of the food safety preventive controls program (Policies, SOPs, Hazard Analysis, HACCP Plan, Prerequisite Food Safety Programs, Traceability & Recall Process, Allergen Programs, and Associated Records) within the assigned facility. Main Accountabilities Ensure compliance with regulatory requirements Food and Drug Administration (FDA) such as federal regulation, local regulation, United States Department of Agriculture (USDA), customer specifications and corporate food safety and quality standards, regional food safety and quality standards, taken appropriate corrective actions when needed. Manage the food safety program and ensures that FDA FSMA preventive controls are effective and proper records are maintained. Provide technical expertise relative to Hazard Analysis and Critical Control Points (HACCP), food safety, sensory and quality evaluations. Conduct monthly-required assessments of the food safety program to ensure compliance. Conduct routine microbiological testing as defined by food safety program. Review and analyse weekly food safety documents including HACCP logs. Utilization of the checklists to determine consistent fulfilment of required food safety program. Support CSC leadership with inspection/audit readiness; coach CSC before, during and after all external, food safety, quality and sanitation inspections/audit. Supervise pest control program and contract services and suppliers related to the food safety program. Conduct appropriate investigations regarding food safety matters and support CSC management in providing detailed information to the customers. Perform and document periodical checks on products and services to ensure quality standards are met. Interface with functional areas (Operations, Production, Sales, and HR), Regional Quality Team, other quality managers to ensure sustainability of the food safety program. Establish and maintain effective working relationships with internal stakeholders across all functions and suppliers, customers and regulatory authorities. Reporting Monitor and prepare reports for the food safety and quality management system. Insertion of monthly-required data in the company web based portal. Collect and monitor all food safety and quality documents (e.g. environmental monitoring, sanitation verifications, chef table, portion control, equipment handling, ramp-on time and safety performance) Keep manuals and documentation updated and implement new procedures and rules in a timely manner. Leadership Possess excellent verbal and written communication skills, including the ability to communicate professionally in person, by phone and through email. Must be able to work in a fast-paced environment while interacting with staff at all levels, and remaining positive, proactive and resourceful. Demonstrates initiative and the ability to work efficiently and independently. Able to read and understand food safety and quality reports and take appropriate action. Must possess a high level of accuracy, attention to detail and is well organized. Recruit, on-board, develop, coach, train, support, and evaluate the performance of the Food Safety staff. Participate and support company sponsored initiatives such as Global Quality Standards (GQS), HACCP, Lean Manufacturing, Employee Safety Knowledge, Skills and Experience Bachelor's degree in Food Science, Food Microbiology, Chemistry, Biology or related fields. Certified Preventive Controls Qualified Individual (PCQI) and Hazard Analysis Critical Control Points (HACCP) Five or more years of experience in Food Safety roles with a minimum of 2 years management experience. Technical proficiency in the areas such as of food microbiology, food chemistry, food safety, and food regulations. Proven understanding of government regulations in relation to food processing as FDA FSMA, Current Good Manufacturing Practices (cGMP), HACCP regulations and USDA. Proven analytical and leadership skills. Strong interpersonal and communication skills. Be a collaborative leader who inspires, manages, coaches and respects people. Excellent verbal, written and organizational skills that combines with an aptitude for multi-tasking. Knowledge of computer skills required, including use of technology (scanners, tablets, printers, copiers, etc.) and Microsoft Office programs, as well as cloud based systems LSG Sky Chefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.
$90k yearly 5h ago
Senior Manager QA Commercial & Life Cycle - CI, BI & DS (Maternity Cover)
Genmab
Quality assurance specialist job in Grafton, MA
At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The role As part of Genmab's strategy to strengthen end-to-end quality oversight across the supply chain, we are seeking a Senior Manager QA - CI, BI & DS to ensure continued strong GMP quality oversight during a period of parental leave with an expected duration until ultimo January 2027. The role is based in Denmark and reports to the Director responsible for QA Commercial. You will be part of an experienced and highly skilled QA team responsible for quality oversight of Chemical Intermediates (CI), Biologic Intermediates (BI), and Drug Substance (DS), working closely with CMOs, partners, and internal SMEs. Key Responsibilities Provide GMP QA oversight of CI, BI, and DS manufacturing activities at external CMOs Review and approve deviations, CAPAs, change controls, and investigations in accordance with Genmab SOPs and regulatory requirements Support batch disposition activities and ensure appropriate quality decisions for CI, BI, and DS including QA review Contribute to Product Quality Reviews (PQR/APR) for CI, BI, and DS Review, author, and maintain QMS documentation, including SOPs, work instructions, and templates Act as QA representative in cross-functional project teams and advise on GMP compliance and regulatory expectations Maintain strong collaboration with internal stakeholders, partners, and CMOs to ensure robust and compliant supply chains Requirements Bachelor's or Master's degree in a relevant life science discipline Minimum 5 years' experience in the pharmaceutical industry, preferably within QA GMP Experience with CI, BI and DS GMP production and delegated QP responsibilities Excellent communication and collaboration skills; fluent in English Ability to thrive in a fast-paced and changing environment Results-oriented and committed to contributing to Genmab's overall success About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
$110k-155k yearly est. 13h ago
QA Technician
Granite Telecommunications 4.7
Quality assurance specialist job in Lincoln, RI
Granite delivers advanced communications and technology solutions to businesses and government agencies throughout the United States and Canada. We provide exceptional customized service with an emphasis on reliability and outstanding customer support and our customers include over 85 of the Fortune 100. Granite has over $1.85 Billion in revenue with more than 2,100 employees and is headquartered in Quincy, MA. Our mission is to be the leading telecommunications company wherever we offer services as well as provide an environment where the value of each individual is recognized and where each person has the opportunity to further their growth and achieve success. Granite has been recognized by the Boston Business Journal as one of the "Healthiest Companies" in Massachusetts for the past 15 consecutive years. Our offices have onsite fully equipped state of the art gyms for employees at zero cost. Granite's philanthropy is unparalleled with over $300 million in donations to organizations such as Dana Farber Cancer Institute, The ALS Foundation and the Alzheimer's Association to name a few. We have been consistently rated a "Fastest Growing Company" by Inc. Magazine. Granite was named to Forbes List of America's Best Employers 2022, 2023 and 2024. Granite was recently named One of Forbes Best Employers for Diversity. Our company's insurance package includes health, dental, vision, life, disability coverage, 401K retirement with company match, childcare benefits, tuition assistance, and more. If you are a highly motivated individual who wants to grow your career with a fast paced and progressive company, Granite has countless opportunities for you. EOE/M/F/Vets/Disabled Summary of Position: The Quality Assurance Representative is responsible for performing detailed quality checks on all equipment being shipped from the Rhode Island Warehouse. This role ensures accuracy in documentation, labeling, and compliance with operational standards, reducing errors and improving customer satisfaction. Duties and Responsibilities: Perform QC checks on all orders to be shipped verify accuracy and functionality. Ensure compliance with standardized procedures. Collaborate with configuration technicians and fulfillment teams to resolve discrepancies. Maintain QC records and contribute to process improvement initiatives. Analyze trending quality issues conduct root cause analysis to be able to reduce the frequency of errors Required Qualifications: High school diploma or equivalent Strong attention to detail and ability to follow standardized procedures. Entry-level experience with basic computer systems, ticketing tools, and documentation platforms Ability to prioritize and manage multiple tasks in a fast-paced environment Strong communication and teamwork skills Ability to lift and move equipment as needed Preferred Qualifications: Associate's degree, technical certification, or equivalent experience. Familiarity with Network equipment and other communications hardware. Proven experience in analytical process improvement, including identifying inefficiencies, implementing corrective actions, and documenting results. Working knowledge of internal ticketing and order management systems. Strong problem-solving skills and ability to adapt to shifting priorities. Prior experience in a fast-paced lab, logistics, or telecom environment.
$31k-45k yearly est. 2d ago
Associate, Third Party Assurance
Banco Santander 4.4
Quality assurance specialist job in Boston, MA
Associate, Third Party AssuranceCountry: United States of America It Starts Here: Santander is a global leader and innovator in the financial services industry and is evolving from a high-impact brand into a technology-driven organization. Our people are at the heart of this journey and together, we are driving a customer-centric transformation that values bold thinking, innovation, and the courage to challenge what's possible. This is more than a strategic shift. It's a chance for driven professionals to grow, learn, and make a real difference. If you are interested in exploring the possibilities We Want to Talk to You! The Difference You Make: As an Associate, Third Party Assurance, you will support FLOD Third Party Risk Management in working with business units to ensure third-parties are managed in accordance with the TPRM program. This function performs due diligence activities including, but not limited to data governance, cyber security, and operational risk. As a member of the team, the Associate, Third Party Assurance implements various risk management processes and strategies for supporting initiatives, capturing and implementing recommendations from audits and other internal/compliance and external/regulatory assessment projects, and employing risk. Applies innovative quantitative and qualitative analytical techniques to detect problems and improve reporting/MIS capabilities. Delivers industry best practices, tools, guidance, and training to increase analytical capabilities and throughput. Partners with Business Lines to recommend and vet new products initiatives, origination strategies, pre-approval and pre-qualification campaigns, underwriting techniques, peer group comparisons, and process optimization. Implements and validates various risk segmentation strategies using complex data. Provides direct support, participation, and oversight for developing, managing, and executing the credit risk strategy, which specifically includes functions such as understanding and leveraging credit-risk analytics to improve portfolio performance. Selects and optimizes risk management processes and strategies for various Small Business initiatives, capturing and implementing recommendations from audits and other internal/compliance and external/regulatory assessment projects, and employing risk. Provide monitoring and assessment of enterprise-wide adherence to vendor management policy requirements Collaborate with colleagues and work towards streamlining processes Consistently deliver on commitments, deadlines and objectives while remaining in scope and leveraging appropriate tools, methods, frameworks, and professional standards Demonstrate the ability to appropriately influence business decisions, and the professional judgment for selecting the appropriate methods and techniques to do so Conduct third party risk assessments, applying established criteria Maintain thorough understanding of all business requirements to support requirements analysis Analyze and develop requirements for enhancements to application functionality Works will other Technical Security personnel to review and interpret vendor due diligence materials, including audit reports and security risk assessment questionnaires Involve appropriate subject matter expertise as required to resolve vulnerabilities Works with the Corporate Vulnerability Management team to conduct vulnerability assessments on remote hosted applications as needed What You Bring: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's Degree or equivalent work experience: Business, Finance, or equivalent degree. - Required. 5+ Years Risk Management - Required. Advanced understanding of key inherent risk and risk management control practices. Strong risk management principles, methodologies and tools, governance principles and activity preferably in a financial services technology environment. Knowledge of workflow/processes and risks/controls, including: origination, underwriting, servicing, and collections/workout. Ability to independently operate in a complex, matrixed environment; adept at delivering and maintaining productive working relationships across business, functions, geographies and lines of defense. Ability to handle conflict resolution with other groups to ensure appropriate accounting guidance is followed. Ability to adjust to new developments/changing circumstances. Ability to convey a sense of urgency and drive issues/projects to closure. Ability to effectively interact with the market, executive management and vendors. Ability to adapt and adjust to multiple demands and competing priorities. Excellent written and oral communication skills. Strong analytical, organizational and project management skills. Certifications: No Certifications listed for this job. It Would Be Nice For You To Have: Established work history or equivalent demonstrated through a combination of work experience, training, military service, or education. Experience in Microsoft Office products. What Else You Need To Know: The base pay range for this position is posted below and represents the annualized salary range. For hourly positions (non-exempt), the annual range is based on a 40-hour work week. The exact compensation may vary based on skills, experience, training, licensure and certifications and location. Base Pay Range: Minimum: $80,625.00 USD Maximum: $140,000.00 USD We Value Your Impact: Your contribution matters and it's recognized. You can expect a fair and competitive rewards package that reflects the impact you create and the value you deliver. We know rewards go beyond numbers. Offering more than just a paycheck our benefits are designed to support you, your family and your well-being, now and into the future. Santander Benefits - 2026 Santander OnGoing/NH eGuide (foleon.com) Risk Culture: We embrace a strong risk culture and all of our professionals at all levels are expected to take a proactive and responsible approach toward risk management. EEO Statement: At Santander, we value and respect differences in our workforce. We actively encourage everyone to apply. Santander is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status or any other characteristic protected by law. Working Conditions: Frequent minimal physical effort such as sitting, standing and walking is required for this role. Depending on location, occasional moving and lifting light equipment and/or furniture may be required. Employer Rights: This does not list all of the job duties of the job. You may be asked by your supervisors or managers to perform other duties. You may be evaluated in part based upon your performance of the tasks listed in this . The employer has the right to revise this at any time. This job description is not a contract for employment and either you or the employer may terminate your employment at any time for any reason. What To Do Next: If this sounds like a role you are interested in, then please apply. We are committed to providing an inclusive and accessible application process for all candidates. If you require any assistance or accommodation due to a disability or any other reason, please contact us at ****************** to discuss your needs.
$80.6k-140k yearly Auto-Apply 4d ago
Quality Assurance Associate
Actalent
Quality assurance specialist job in Waltham, MA
We are seeking a dedicated Quality Assurance Associate to support on-the-floor QA issues within our manufacturing suite. You will play a crucial role in mitigating gaps and risks for all quality and GMP processes, and will run investigations for deviations, change controls, CAPAs, and out-of-specifications. Additionally, you will review and author SOPs to ensure compliance with industry standards. Responsibilities * Support on-the-floor QA issues within the manufacturing suite. * Mitigate gaps and risks for all quality and GMP processes. * Conduct investigations for deviations, change controls, CAPAs, and out-of-specifications. * Review and author Standard Operating Procedures (SOPs). Essential Skills * Proficiency in quality assurance and document control. * Experience with batch record review, CAPA, and deviation management. * Knowledge of compliance, audits, and quality systems management. * Familiarity with cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines. Additional Skills & Qualifications * Bachelor's degree with 3-5 years of experience. * Experience supervising or managing direct reports. * Capability to support GMP requirements and compliance. Work Environment The role involves working with a team of 3-4 individuals. It is a first shift, Monday to Friday business casual environment, with occasional weekend work required. The company values hard-working individuals who are great team players. Enjoy contractor perks such as participation in all company events, a fully stocked kitchen, company-provided lunches twice a week, and access to an on-site gym that's open 24/7. Job Type & Location This is a Contract to Hire position based out of Waltham, MA. Pay and Benefits The pay range for this position is $43.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Waltham,MA. Application Deadline This position is anticipated to close on Jan 23, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$43-45 hourly 6d ago
Quality Assurance Associate II
Nygci
Quality assurance specialist job in Framingham, MA
NYGCI was founded in 2007 in New York State. Since then we have expanded our services footprint to 27+ states within USA, representing our service presence in more than 50% of US.We provide IT Professional Services to local, regional and global customers and reduce their IT risk and maximize their IT performance. Job Description The QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with relevant quality standards, relevant regulatory councils, and other regulatory requirements and perform administrative tasks.. Years of Experience: 3 - 6 Years Shift Day Work Schedule: 8:00-5:00 Additional Information All your information will be kept confidential according to EEO guidelines.
$51k-74k yearly est. 60d+ ago
Quality Assurance Senior Associate, Biopharma (JP10480)
3 Key Consulting
Quality assurance specialist job in West Greenwich, RI
Employment Type: Contract Business Unit: Plant Quality Assurance Duration: 10 months with likely extensions or conversion to permanent 3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing. Primary responsibilities of this position include: Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to equipment used records, work orders, job plans, reports and batch records. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations. Complete required assigned training for self to permit execution of required tasks. Perform training activities, as needed. Support operational improvement initiatives, programs and projects. Perform walkthroughs/inspections of areas to ensure housekeeping and GMP are maintained Skills: Quality assurance or manufacturing experience in the pharmaceutical or medical device industry Strong cGMP and GDP behaviors Strong word processing, presentation, database and spreadsheet application skills Strong organizational skills and ability to manage multiple tasks at one time Knowledge of electronic systems including LIMS, Trackwise, and Maximo. Why is the Position Open? Supplement additional workload on team. Top Must-Have Skill Sets: Ability to work in teams, flexible to work in an everchanging work environment Quality assurance or manufacturing experience in the pharmaceutical or medical device industry Strong cGMP and GDP behavior Employee Value Proposition: Growth/ opportunity. Red Flags: No previous experience, inability to gown up per requirements for manufacturing and support on the floor operations. Interview process: Virtual 3 interviews with some key players We invite qualified candidates to send your resume to *****************************. If you decide that you're not interested in pursuing this position, please feel free to look at the other positions on our website ******************************* You are welcome to also share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team
$52k-76k yearly est. Easy Apply 60d+ ago
Showroom Quality Assurance Associate
Supply New England 3.2
Quality assurance specialist job in Attleboro, MA
Summary/Objective The Showroom Quality Assurance Associate ensures that the kitchen and bath showrooms are maintained at high standards, supports the installation of displays, and provides post sale customer service to guarantee a positive showroom experience. Wage: $25.00/hr-$27.00/hr Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Showroom display installation & maintenance. Demo and removal of showroom displays Merchandising pieces Cabinetry Dry-fit plumbing fixture installs (pedestal sinks, toilets, faucets, etc) Painting, drywalling & drywall repair Wallpaper installation Tile installation Hanging display boards Maintaining a variety of showroom lighting systems; sourcing and replacing lamps and parts Additional tasks based on company needs Travel to customer homes or job sites in New England to help with light service issues. Assist with project management to accommodate more complex showroom installations. Communication, scheduling, materials planning, etc. Quality assurance by confirming all showroom installations meet brand standards. Checking all displays are installed properly and undamaged. Report defects or inconsistencies and work to resolve issues quickly. Competencies Communication Computer literacy (email, Microsoft, internet search etc.) Organizational skills Time management Customer service Relates well to others Problem Solving Job related skills Safety awareness General knowledge of plumbing and electrical work Good knowledge of carpentry; wood working, millwork, finish work Required Education and Experience High school diploma or GED Experience with general “handyman” tasks Clean driving record Tile installation a plus
$25-27 hourly 3d ago
ICQA Associate II
Barrett Distribution Center 2.9
Quality assurance specialist job in Bridgewater, MA
The Position:The ICQA Associate II, reporting to the ICQA Manager/Supervisor, is responsible for inventory cycle counting and tracking and monitoring inventory within the warehouse. This position works Monday through Friday, from 8am- 4:30pm. Expectation also to work from the Franklin facility 1x per week. The compensation for this position is $17.50/hour. Your Day-to-Day: Performs daily cycle counts as directed by Inventory Manager, Lead, or Supervisor. Reports, troubleshoots, and resolves inventory discrepancies as directed; escalated to facility leadership as needed. Verifies quantity on hand by opening cartons, bundles, and other containers to count items and/or weigh materials. Researches, identifies, and documents root cause inventory discrepancies. Audits inbound and outbound shipments to maintain inventory accuracy and quality. Assists employees in following SOP procedures for inventory transactions. Maintains product identification, location, and lot code accuracy in appropriate systems. Reports verbally and in writing on inventory accuracy or discrepancies Assists with monitoring and controlling inventory integrity. Works on special projects affecting inventory as directed by the customer. Utilizes Barrett's Powered Industrial Vehicles (PIV) to complete necessary duties. Barrett PIV Certification is required within the first 30 days (or as dictated by facility need); certification must remain in good standing. Performs other duties as assigned. What You Bring to the Table: High school diploma/GED preferred. Forklift certification strongly preferred. Minimum of one (1) year's experience as a cycle counter in a warehouse/distribution setting. Experience conducting process audits and audits on inbound and outbound shipments. Knowledge of Lean concepts preferred. Working knowledge of warehouse management systems preferred. Ability to read, write, and communicate effectively in English (Bilingual Spanish/English skills preferred). Basic math skills - add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Must be able to interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Experience must demonstrate excellent verbal and written communication skills, as well as organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines and the ability to function well in a high-paced and, at times, stressful environment. The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by the personnel so classified. Barrett Distribution Centers is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender, gender identity/expression, mental or physical disability, genetic information, choice of health insurance, marital status, age, veteran status or any other basis protected by law.
$17.5 hourly 21d ago
Testing Lead (Hiring Immediately)
Guidehouse 3.7
Quality assurance specialist job in Boston, MA
Job Family: Technology Consulting Travel Required: Up to 25% Clearance Required: None What You Will Do: The Testing Lead will serve as the overall owner of the testing program for the Commonwealth of Massachusetts statewide Oracle Health (Cerner) EHR implementation. This role is responsible for designing, executing, and validating a comprehensive testing strategy that spans all phases of the implementation lifecycle, including unit, system, integration, regression, and user acceptance testing. The Testing Lead will ensure that all workflowsclinical, financial, operational, and technicalare validated for safety, reliability, and compliance across DPH hospitals, DMH facilities, SOPS, and community-based services. Key Responsibilities Testing Strategy and Governance Develop and maintain the Master Test Plan, including scope, schedule, entry/exit criteria, traceability, and risk posture. Chair the Testing Governance Committee, escalating risks, defects, and go/no-go recommendations to the Steering Committee. Establish consistent application of methodology across all facilities and testing events. Provide executive-level reporting to EOHHS leadership on readiness, defect posture, and overall progress. Testing Execution and Oversight Lead all testing events including: Unit Testing: Validate build objects (orders, flowsheets, dictionaries, charge codes). Build Quality Audit (BQA): Confirm configuration accuracy and compliance with Oracle Health standards. System Testing: Validate end-to-end workflows within facilities. Integration Testing: Confirm HL7/FHIR message integrity across labs, imaging, MIIS, PBM claims, and SOPS Meta. Security Testing: Validate role-based access, HIPAA, and 42 CFR Part 2 compliance. Accessibility Testing: Confirm WCAG 2.1 AA standards for behavioral health and vulnerable populations. Charge and Claims Testing: Validate financial workflows and payer adjudication. Parallel Revenue Cycle Testing: Reconcile Oracle Health Patient Accounting with legacy MEDITECH systems. Data Migration Testing: Confirm completeness and accuracy of migrated data. Device Testing: Validate integration of bedside and ancillary devices. Performance and Stress Testing: Confirm system responsiveness and resilience. User Acceptance Testing (UAT): Validate real-world workflows with EOHHS super users. Post-Live Smoke Testing: Confirm core functions are stable immediately after cutover. Regression Testing: Ensure upgrades and patches do not disrupt validated workflows. Tools and Automation Manage automation frameworks using Oracle Health Test Studio, Tricentis Tosca, and interface replay harnesses. Prioritize automation for repetitive workflows (e.g., admit order MAR charge) to reduce burden on state staff. Maintain defect tracking in Jira/Confluence, with dashboards for aging, velocity, and closure trends. Use Smartsheet and Power BI for readiness dashboards and reporting. Environment and Data Management Maintain stable, synchronized testing environments across Waves 1 and 2. Manage test data creation, de-identification, and seeding. Coordinate with Oracle Health on environment refresh cycles and defect fix migrations. Stakeholder Engagement and Collaboration Collaborate with Domain Test Managers, Defect Manager, Automation Lead, and EOHHS champions. Facilitate daily stand-ups, defect triage sessions, and readiness reviews. Ensure EOHHS staff are engaged as validators, not burdened as primary testers. Document all testing decisions, results, and evidence in the Oracle Project Portal. Organizational Impact and Communication Leads cross-functional testing teams across clinical, financial, and technical domains. Communicates complex testing strategies to stakeholders at all levels. Ensures alignment with Commonwealths enterprise architecture and governance standards. Innovation and Complexity Designs scalable, compliant, and resilient testing architecture across diverse care settings. Navigates complex legacy environments and fragmented workflows. Applies structured, repeatable methodologies for high-risk testing domains. Leadership and Talent Management Manages domain test managers, automation engineers, defect analysts, and environment coordinators. Provides mentorship, performance feedback, and escalation support across all testing workstreams. Coordinates with PMO, Technical Lead, and Functional Leads to ensure delivery milestones are met. What You Will Need: Minimum 10 years of experience in healthcare IT testing, with at least 5 years in leadership roles. Proven experience with Oracle Health Millennium and RevElate testing frameworks. Deep understanding of EHR testing best practices, including parallel revenue cycle testing, EMPI validation, and integrated testing. Experience testing in public sector environments, including DPH, DMH, and SOPS workflows. Familiarity with HL7/FHIR standards, device integration, and interface validation. Strong knowledge of compliance testing (HIPAA, 42 CFR Part 2, ADA/Section 508). Expertise in testing governance, defect management, and automation tools. Excellent communication, stakeholder engagement, and documentation skills. What Would Be Nice To Have: Certifications in ISTQB, HIMSS, or Oracle Health testing tools. Experience with federal/state EHR implementations, including VA or DoD projects. Familiarity with Oracle Cloud Infrastructure (OCI) and hybrid hosting models. Experience with behavioral health, correctional, and long-term care testing scenarios. The annual salary range for this position is $130,000.00-$216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs. What We Offer: Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: Medical, Rx, Dental & Vision Insurance Personal and Family Sick Time & Company Paid Holidays Position may be eligible for a discretionary variable incentive bonus Parental Leave and Adoption Assistance 401(k) Retirement Plan Basic Life & Supplemental Life Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts Short-Term & Long-Term Disability Student Loan PayDown Tuition Reimbursement, Personal Development & Learning Opportunities Skills Development & Certifications Employee Referral Program Corporate Sponsored Events & Community Outreach Emergency Back-Up Childcare Program Mobility Stipend About Guidehouse Guidehouse is an Equal Opportunity EmployerProtected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at ************** or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or ************************. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide y
$130k-216k yearly 1d ago
QC Investigations Specialist
JMD Technologies Inc.
Quality assurance specialist job in Boston, MA
Title: QC Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This role supports real-time manufacturing operations by leading investigations, resolving on-floor issues, and ensuring high-quality documentation. You'll partner closely with manufacturing, QC, materials, and facilities teams to maintain operational continuity and compliance. Key Responsibilities • Triage manufacturing issues and lead analytical investigations and root cause analysis. • Write clear, compliant quality documentation including deviations and CAPAs. • Coordinate with SMEs to determine immediate actions, containment, and impact assessments. • Interpret data to support structured problem-solving and continuous improvement. • Provide technical operations support across manufacturing and QC functions. Qualifications • 6+ years pharmaceutical or biotech manufacturing experience. • 4+ years analytical investigation and QC-focused experience. • Strong background in RCA, deviation management, and GxP documentation. • Ability to interpret analytical data and think scientifically under time-sensitive conditions. • Experience partnering cross-functionally with manufacturing, QC, materials, and facilities teams. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$55/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.
$50-55 hourly 3d ago
Director, GMP QA
Genmab
Quality assurance specialist job in Grafton, MA
At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role Genmab is seeking an experienced and strategically oriented QA Director for Chemical Intermediates (CI), Biological Intermediates (BI), and Drug Substance (DS) to lead Quality Assurance oversight of CI, BI, and DS activities supporting commercial products, all manufactured through external partners. This role plays a critical part in safeguarding product quality, patient safety, and supply reliability in a fully outsourced manufacturing model. In addition, the role carries responsibility for building and scaling a fit-for-purpose QA organization for CI, BI, and DS over the coming years, aligned with the expansion of Genmab's commercial portfolio and global CMO network. You will be part of the global GMP QA organization and a key member of the QA leadership team, reporting directly to the Team Lead of QA GMP Commercial. Key Responsibilities The responsibilities of the QA Director for CI / BI / DS will include, but not be limited to: Define and drive the QA strategy for CI, BI, and DS supporting commercial products in a fully outsourced manufacturing model. Provide end-to-end QA oversight of commercial CI, BI, and DS manufacturing activities at CMOs, ensuring sustained GMP compliance and supply continuity. Hold overall responsibility for QA release of CI, BI, and DS, including establishment of release strategies, governance, and escalation pathways. Ensure robust review and approval of batch documentation and manufacturing data supporting release decisions, in accordance with Genmab's Pharmaceutical Quality System. Build, scale, and develop the CI / BI / DS QA organization, including defining future capabilities, roles, and competencies in line with business growth. Lead, mentor, and develop a growing QA team, fostering a strong quality culture and ensuring succession and knowledge management. Establish and maintain robust quality agreements and governance models with CMOs, ensuring clear accountability and escalation pathways. Oversee deviations, CAPAs, change controls, and risk assessments related to commercial CI, BI, and DS manufacturing. Ensure QA oversight of continued process verification, ongoing validation, and lifecycle management for commercial processes. Drive inspection readiness and lead QA support for regulatory inspections at CMOs, including routine and for-cause inspections. Plan, perform, and follow up on audits of CMOs and critical suppliers supporting commercial manufacturing. Provide QA input to regulatory submissions, variations, and post-approval changes related to CI, BI, and DS. Act as a key QA interface to Supply Chain, proactively identifying and mitigating quality-related risks to commercial supply. Contribute to continuous improvement of Genmab's Pharmaceutical Quality System with focus on commercial operations and outsourced manufacturing. What We Are Looking For You hold a MSc degree in life science. Minimum 10 years of experience within the pharmaceutical industry, with extensive GMP QA experience supporting commercial CI, BI, and/or Drug Substance manufacturing at CMOs. Proven experience building and scaling QA teams in response to business growth and increasing complexity. Strong understanding of biologics manufacturing (e.g. monoclonal antibodies) and associated intermediates; experience with chemical intermediates is an advantage. Demonstrated experience with commercial-stage CMO oversight, quality agreements, audits, and regulatory inspections. Strong people leadership and organizational design capabilities. Solid knowledge of global GMP and ICH requirements and post-approval lifecycle management. Comfortable operating in a high-complexity, supply-critical environment. Excellent English communication skills and a pragmatic, risk-based QA mindset. What You'll Gain A QA leadership role with direct impact on commercial product quality, patient safety, and supply reliability. The opportunity to build and mature a scalable QA organization supporting a growing commercial portfolio. A role combining long-term strategic ownership with hands-on engagement in complex, supply-critical manufacturing activities. A collaborative, performance-driven culture that values quality, accountability, and continuous improvement. About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
$112k-161k yearly est. 18h ago
Food Safety Quality Assurance Coordinator
LSG Sky Chefs 4.0
Quality assurance specialist job in Boston, MA
Job Title: Food Safety Quality Assurance Coordinator Salary Range: $18.00 - 25.00 per hour About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Our team members are the heart and soul of our success, consistently delivering exceptional culinary experiences and outstanding service to our clients and their passengers across North and Latin America. Role Purpose Statement Primary responsibility is to maintain the "Global Quality System" of LSG Sky Chefs to ensure the Customer Service Center (CSC) is in compliance with customer, Federal Drug Administration (FDA), US Department of Agriculture (USDA), and Seafood Hazard Analysis and Critical Control Points (HACCP) plans including USDA and FDA regulatory standards. Main Accountabilities Maintain and initiate all recordkeeping and key performance indicators pertinent to the Quality Department and GQS to include, but not limited to Food Safety, Sanitation, Regulatory Agencies (County Health, State Health Dept. and FDA), internal customers and airline customers Daily monitor of Good Manufacturing Practices (GMPs) for compliance Verify of coolers and freezer room temperature for compliance Perform environmental swabs and microbiological sampling, submittal to local laboratory for analysis Obtain Chef Table samples to verify compliance to specification Assist the Quality Manager in specific training and daily initiatives addressing quality, food safety, and sanitation issues to drive process improvements Conduct work station inspections to verify compliance (gold standard verification, specs, sanitizer, food temperatures, HACCP documentation, phf set-up) Conduct portion control weight compliance to specifications Conduct inspection checks (dispatch, galley, non-bonded, bonded, equipment) Verify Hazard Analysis and Critical Control Points (HACCP) logs and other documents are accurately completed on a daily basis Create charts, trending reports, training materials and visuals Maintain, monitor standards and train employees in compliance to the Regulated Garbage Standards to meet USDA requirements Supports the Jump-off (commissary) locations with oversight Train hourly employees as needed Perform other tasks as requested Knowledge, Skills and Experience High School Diploma or equivalent Proficient in using computer and basic software such as Microsoft, create and maintain trending charts, SOP's, use of calculator, weight scales, and thermometers, metal detector, ATP testing equipment, mechanical food portioning and processing equipment. Previous food industry and quality assurance experience a plus Ability to work in cold environment ( Ability to work with minimum to no supervision, act in liaison of the Supervisor, self-starter, and problem solver. Ability to lift/push a minimum of 25 lbs. Strong mathematical, analytical, verbal, written, interpersonal and organizational skills Ability to work in fast paced environment with large groups Must be flexible to work weekends/holidays LSG Sky Chefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.
$18-25 hourly 5h ago
Quality Assurance Associate
Actalent
Quality assurance specialist job in Waltham, MA
Job Title: Quality Assurance AssociateJob Description We are seeking a dedicated Quality Assurance Associate to support on-the-floor QA issues within our manufacturing suite. You will play a crucial role in mitigating gaps and risks for all quality and GMP processes, and will run investigations for deviations, change controls, CAPAs, and out-of-specifications. Additionally, you will review and author SOPs to ensure compliance with industry standards. Responsibilities + Support on-the-floor QA issues within the manufacturing suite. + Mitigate gaps and risks for all quality and GMP processes. + Conduct investigations for deviations, change controls, CAPAs, and out-of-specifications. + Review and author Standard Operating Procedures (SOPs). Essential Skills + Proficiency in quality assurance and document control. + Experience with batch record review, CAPA, and deviation management. + Knowledge of compliance, audits, and quality systems management. + Familiarity with cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines. Additional Skills & Qualifications + Bachelor's degree with 3-5 years of experience. + Experience supervising or managing direct reports. + Capability to support GMP requirements and compliance. Work Environment The role involves working with a team of 3-4 individuals. It is a first shift, Monday to Friday business casual environment, with occasional weekend work required. The company values hard-working individuals who are great team players. Enjoy contractor perks such as participation in all company events, a fully stocked kitchen, company-provided lunches twice a week, and access to an on-site gym that's open 24/7. Job Type & Location This is a Contract to Hire position based out of Waltham, MA. Pay and Benefits The pay range for this position is $43.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Waltham,MA. Application Deadline This position is anticipated to close on Jan 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
$43-45 hourly 7d ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in Fall River, MA?

The average quality assurance specialist in Fall River, MA earns between $53,000 and $114,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in Fall River, MA

$78,000

$53,00010%

$78,000Median

$114,00090%

What are the biggest employers of Quality Assurance Specialists in Fall River, MA?

The biggest employers of Quality Assurance Specialists in Fall River, MA are:

Cipla
Cipla Ltd.
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Quality Assurance Specialist Fall River, MA Jobs

Quality assurance specialist jobs in Fall River, MA - 419 jobs

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Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in Fall River, MA?

What are the biggest employers of Quality Assurance Specialists in Fall River, MA?