Quality assurance specialist jobs in New Bedford, MA

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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 21h ago
Head of Quality Assurance
Vivid Resourcing
Quality assurance specialist job in Boston, MA
Our client, an innovative biopharmaceutical company based in Boston, is seeking a Head of Quality Assurance to lead the overall QA function and ensure the highest standards of GMP compliance, product quality, and operational excellence across development and commercial activities. This individual will serve as the company's senior QA leader, responsible for setting the quality vision, overseeing GxP compliance, building and developing quality teams, and partnering closely with Manufacturing, CMC, Technical Operations, Supply Chain, and Regulatory Affairs. This is a high-impact, onsite leadership role ideal for a seasoned QA executive with strong GMP experience in biologics, advanced therapies, or other regulated modalities. Key Responsibilities Quality Leadership & Strategy Define, implement, and lead the company-wide Quality Assurance strategy in alignment with organizational goals and global regulatory expectations. Serve as the primary authority on QA standards, policies, and GxP compliance across all operations. Provide strategic oversight across GMP, Quality Systems, QA Operations, and Supplier Quality. GMP Compliance & Quality Systems Ensure full compliance with FDA, EMA, ICH, and global regulatory guidelines. Oversee development, maintenance, and continuous improvement of the Quality Management System (QMS). Lead GMP oversight of manufacturing operations, batch record review, and product release activities. Manage deviation investigations, CAPAs, change controls, and quality risk management processes. Manufacturing & Operational Quality Partner closely with internal and external manufacturing teams to ensure quality oversight throughout the product lifecycle. Support tech transfers, scale-up activities, comparability, and process validation from a QA perspective. Provide quality leadership for raw materials, suppliers, CMOs, and testing labs. Regulatory & Inspection Readiness Act as a key interface with regulatory agencies on quality-related matters. Lead site inspection readiness activities and manage responses to regulatory findings. Provide QA input into regulatory submissions, including Module 3 and GxP documentation. People Leadership & Organizational Development Lead, mentor, and build a high-performing QA team covering Quality Systems, QA Operations, Supplier Quality, and Quality Compliance. Establish clear expectations, training, and succession planning to support growth and scalability. Foster a culture of accountability, continuous improvement, and proactive quality thinking. Qualifications Education Bachelor's degree required; advanced degree (M.S., Ph.D., Pharm.D.) in a life sciences discipline preferred. Experience 12-18+ years of progressive experience in Quality Assurance within the biopharmaceutical industry. 7+ years in QA leadership roles managing teams and complex GxP operations. Strong background in GMP quality oversight, manufacturing operations, and QMS management. Experience working with biologics, cell & gene therapies, mRNA, or other complex modalities strongly preferred. Proven track record of inspection readiness and successful interactions with FDA, EMA, or other global authorities. Experience supporting clinical and/or commercial product quality. Skills & Leadership Attributes Deep understanding of global GxP regulations and industry standards. Exceptional communication, influencing, and leadership capabilities. Strong problem-solving skills with a proactive and solutions-driven mindset. Ability to work onsite and engage closely with lab, manufacturing, and technical teams. High integrity and commitment to patient safety and product quality. Additional Information Work Model: Fully onsite in Boston; daily leadership presence required. Travel: Occasional domestic or international travel to partners, CMOs, or regulatory meetings. Compensation: Competitive executive-level compensation including base salary, bonus, equity, and benefits.
$83k-122k yearly est. 21h ago
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 4d 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
Quality Control Specialist, QC Sample Management
Randstad USA 4.6
Quality assurance specialist job in Norwood, MA
Shift Schedule: Wednesday - Saturday, 1st Shift (10-Hour Schedule) Compensation: $45.00/Hour Role Type: Contract with potential extension The Opportunity We are seeking a highly motivated and detail-oriented Quality Control Specialist to lead the growing QC Sample Management function. This is a pivotal, high-impact role operating at the intersection of science, digital systems (like LIMS), and continuous improvement. You will serve as the Subject Matter Expert (SME) for cGMP sample lifecycle activities, leading a team of associates and ensuring timely, compliant sample coordination and testing across internal and external laboratories worldwide. Key Responsibilities: Here's What You'll Do Team Leadership & Operations Management Lead a team of QC Sample Management Associates supporting Chemistry, Microbiology, Bioassay, and Raw Materials workflows from CMOs and Development labs. Oversee and coordinate the daily schedule to ensure timely sample processing, compliance documentation, and lab record completion. Create weekly schedules, lead team meetings, and manage hiring, onboarding, development, and performance reviews (including 1:1 coaching) for associates. Maintain compliance of training records for the team. Quality Systems & Digital Innovation Act as the primary support for audit readiness and actively participate in internal and external inspections. Author and revise SOPs, quality records, deviations, CAPAs, and change controls. Lead investigations and resolution of compliance issues related to sample handling. Partner with Digital teams to expand and optimize the use of our Laboratory Information Management System (LIMS, specifically LabVantage). Contribute to the pathway for incorporating next-generation data tools, including Generative AI, into QC workflows to drive efficiency and data automation. Laboratory Maintenance Manage controlled temperature unit (CTU) systems, including maintenance and troubleshooting. Foster a robust culture of safety and compliance within the lab environment. Basic Qualifications (Here's What You'll Need) BA/BS in a relevant scientific discipline with a minimum of 3-5 years of Quality Control experience in a cGMP organization, OR MS in a relevant scientific discipline with a minimum of 1-3 years of Quality Control experience in a cGMP organization. Technical Skills: Detailed working knowledge of LIMS systems (e.g., LabVantage) and quality document systems (e.g., Veeva). Working knowledge of relevant and current FDA, EU, and ICH guidelines and regulations. Experience with gowning, aseptic technique, and general lab safety practices.
$45 hourly 2d ago
Software Quality Assurance Analyst
Boston Data Pro, LLC
Quality assurance specialist job in Norwood, MA
We are seeking an experienced Manual QA Analyst to validate high-traffic, customer-facing digital platforms, including Point-of-Sale (POS) systems, Mobile Applications, Delivery Platforms, and Web Applications. This is a hands-on manual testing role focused on ensuring reliability, accuracy, and seamless end-to-end user experience across omnichannel systems. THIS IS A HYBRID ROLE : 3 days a week. LOCAL TO BOSTON AREA CANDIDATES ONLY. Roles & Responsibilities Execute manual functional, integration, system, regression, and UAT testing across POS, mobile, delivery, and web platforms Validate end-to-end business workflows, including ordering, payments, discounts, taxes, loyalty, refunds, cancellations, and order fulfillment Create, maintain, and execute detailed test scenarios, test cases, and test execution reports Perform smoke and sanity testing for every new build and release Validate integrations between:POS systems, Mobile apps,Third-party delivery partners,Payment gateways Identify, log, track, and re-test defects using defect management tools such as Jira or Azure DevOps Work closely with Product Managers, Developers, Business Analysts, and Operations teams to understand requirements and ensure complete test coverage Participate in requirement reviews, sprint planning, daily stand-ups, and release validation activities Validate cross-browser, cross-device, and cross-platform compatibility Support User Acceptance Testing (UAT) and post-production validation Ensure testing aligns with real-world business operations, not just technical requirements Continuously improve test coverage, test documentation quality, and QA processes.
$64k-85k yearly est. 21h ago
Radiology Quality Assurance Specialist - MRI Research
Massachusetts Eye and Ear Infirmary 4.4
Quality assurance specialist job in Boston, MA
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. We're offering a generous sign-on bonus ($20,000) to welcome you to our team. Recognizing and valuing exceptional talent, we're eager to discuss the exciting details of this bonus during our interview process. Flexible schedule (4x10 onsite or 5x8 with one remote day) This position is responsible for facilitating a comprehensive quality improvement program within the radiology department. Previous experience as a licensed imaging technologist is required for this position. Job Summary The Quality Assurance Specialist - MRI Research works as part of a multidisciplinary team following established policies and procedures and is responsible for safely operating and training research personnel to acquire research images on imaging equipment. • Participates in the day-to-day technical activities of a wide range of human and animal imaging research projects being conducted in the Radiology Research Imaging Core. Responsibilities include assistance in the implementation of radiology research imaging protocols in collaboration with Principal Investigators, Research Assistants, Clinical Managers, Physicists, Applications Specialists and QA Specialists. • Facilitates imaging protocol development on scanners in accordance with IRB and IACUC approved protocols and imaging manuals. Generates training documents to ensure accurate and consistent imaging acquisition and processing for longitudinal research results. • Daily operational tasks may include scheduling exams in Epic and Research Percipio, monitoring data transfer to Research PACS, assigning images to Principal Investigators and team, and obtaining safety reads by radiologists. • Working independently but under the general supervision of the Director, orders laboratory supplies, equipment, and services as needed. • All other duties, as assigned Qualifications Does this position require Patient Care? Yes Essential Functions Provide data consultation and staff support to clinical, operational process improvement individuals, patient safety individuals, etc. Collect data, implement new protocols, provide education to staff in efforts to improve quality within the department Collaborate with leadership, staff, and radiologists to ensure exam protocols, patient care processes, and image quality are optimized Collects and analyzes quantitative and qualitative statistical data and work with vendors to resolve technical problems Function as technologist to maintain optimal direct patient care skills and imaging skills Provides radiation protection in accordance with prescribed safety standards; records digital images as directed for radiologist interpretation Education Associate's Degree Health Science required Can this role accept experience in lieu of a degree? No Licenses and Credentials Basic Life Support [BLS Certification] - Various Issuers preferred Heartsaver CPR AED [CPR] - American Heart Association (AHA) preferred Magnetic Resonance Imaging [ARRT-MR] - American Registry of Radiologic Technologists (ARRT) required OR American Registry of Magnetic Resonance Imaging Technologists (ARMRIT) required Experience Radiology Technologist experience with multiple patient populations 5-7 years required Quality experience 2-3 years preferred Knowledge, Skills and Abilities Good communication skills. Ability to effectively evaluate and problem solve. Ability to work independently. Ability to guide, teach, and motivate others. Good business acumen and analytical skills. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 221 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $37.55 - $55.48/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
$37.6-55.5 hourly Auto-Apply 11d ago
Quality Assurance Auditor
Thales 4.5
Quality assurance specialist job in North Kingstown, RI
Location: North Kingstown, United States of AmericaThales people architect identity management and data protection solutions at the heart of digital security. Business and governments rely on us to bring trust to the billons of digital interactions they have with people. Our technologies and services help banks exchange funds, people cross borders, energy become smarter and much more. More than 30,000 organizations already rely on us to verify the identities of people and things, grant access to digital services, analyze vast quantities of information and encrypt data to make the connected world more secure. Position Summary This is an on-site position in North Kingstown, RI. This position is eligible for the Americas referral program for external candidates: Tier 1 - $2500 Referral Bonus. Provide quality service to our customer's by the internal auditing of their mail kit product to ensure that the highest production and quality is achieved according to established standards and procedures. Key Areas of Responsibility General understanding of client's completed mail kit product: Job sheet reading/ filling, ISO/ CQM requirements, Process understanding, Control plan interpretation. Understanding of calibration and verification concepts. Understanding of AQL, military standard concept and use. Understanding and application of Non conformity process. Fully understands and follows established QA procedures while performing the internal QA audit function. Must be proficient in QA procedures. Audits jobs from Data Card, Hand Fulfillment and Auto Inserting departments. Understanding of Company's JAAMS system for department's audit input procedures. Hands-on knowledge and usage of job tracking system. Generate non-conformance report to management. Provide feedback to QA manager of any excessive errors discovered during the auditing process. Provide support to production floor on inspection/ segregation of non-conforming product. Validate new products/ portfolios. Maintain a positive attitude and understanding toward fellow co-workers Must be flexible with working nights and weekends as this may be required for major projects. Ensure conformance to vision, mission and values of the company. Must be detail oriented and highly focused to meet the customer's expectations. Ability to work independently with minimal supervision. Minimum Requirements: Education and/or Experience: Must have 1 - 3 years' experience working in a manufacturing and/or production environment. Bachelor's degree preferred . Personal Characteristics: Basic analytical, numerical, and reasoning abilities. Well-developed interpersonal skills. Ability to get along with diverse personalities. Tactful and mature. Ability to work independently and self-directed. Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Excellent people skills, attention to detail. Excellent communication skills, written and verbal skills required. Mathematical Skills: Basic math skills required. Intermediate computer skills also needed. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Results oriented with the ability to balance other business considerations. #LI-Onsite #LI-AS007 This position will require successfully completing a post-offer background check. Qualified candidates with [a] criminal history will be considered and are not automatically disqualified, consistent with federal law, state law, and local ordinances. Successful applicant must comply with federal contractor vaccine mandate requirements. Thales champions inclusion and we believe diversity strengthens the fabric of our culture. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. If you need an accommodation or assistance in order to apply for a position with Thales, please contact us at ************************************.
$84k-112k yearly est. Auto-Apply 60d+ ago
QA Automation Specialist
Us Tech Solutions 4.4
Quality assurance specialist job in Boston, MA
Experienced in implementing Agile scrum methodology developing and leading software QA programs and teams developing test metrics, test strategy, test plans, built test beds and automation infrastructure built frameworks to execute tests and analyzing results Experienced in performing all types of testing including manual, automated, functional, installation, acceptance, compatibility, load, stress, UAT, performance, volume, data driven, backend. Extensively used testing tools like Robot Framework, Selenium IDE, Selenium RC, Selenium WebDriver Selenium Grid, QTP, QC, SOAP UI, Winrunner, Loadrunner Extensively worked on Java/J2EE technologies including core Java 1.6, Junit 4, Ant, maven, Apache Tomcat, Jakarta Struts, Spring, Hibernate, Swing, Applet, Apache Tomcat, PL/SQL, Worked in javascript based technologies like nodejs, angular.js, cucumberjs, webdriverjs, protractor, karma, chai, cucumber, mongodb, Grunt Experience in automation technologies like, Chef, Puppet, Rundeck Jenkins, Cruise Control, Selenium Grid/RC/ Webdriver, Maven, Ant, Junit benchmark, Httpwatch, BrowserMob proxy, Jmeter, Watir Experienced in creating Java Technology based web application, web portals, standalone applications, component development, database design and GUI interfaces Strong background in the area of Medical Insurance, Health Information Systems, Coding and Reimbursements, Clinical and Economical research, Geographical Information Systems and Financial Services Familiarity with testing cloud-based applications, AWS, TDD, BDD, agile testing pyramid, collecting quality metrics from CI/CD tooling. Additional Information All your information will be kept confidential according to EEO guidelines.
$53k-86k yearly est. 60d+ ago
Documentation Specialist II (JOB ID- 5608200)
Artech Information System 4.8
Quality assurance specialist job in Canton, MA
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job Description: Processing Quality Assurance Doc Control controlled GMP documentation in support of production activities. Management of documentation lifecycle. Archival of quality controlled documentation. Working with individuals and teams to ensure timely delivery of controlled documentation. Formatting, editing drafts of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work in dynamic with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Experience: 3 to 6 years. Skills: Expert word processing skills including Adobe Acrobat Professional Attention to detail Self-managed critical thinker Ability to learn quickly and acclimate to a fast-paced dynamic culture Education: Degree preferred- level of experience may be considered equivelant Qualifications BS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960
$44k-75k yearly est. 60d+ ago
Haitian Creole Bilingual Quality Assurance Administrator
Maximus 4.3
Quality assurance specialist job in Boston, MA
Description & Requirements Maximus is currently hiring a remote Haitian Creole Bilingual Quality Assurance Administratorto support the Florida Healthy Kids (FL HK) program operations and ensure compliance with established standards and Florida healthcare policies. In this role, you will be responsible for monitoring phone calls and completing back-office quality reviews to determine whether employees are meeting required performance, quality, and compliance standards. You will also participate in special projects and program initiatives as needed and serve as backup support for the call center during periods of high volume or operational need. The ideal candidate demonstrates strong attention to detail, excellent critical thinking and analytical skills, and the ability to accurately interpret and apply Florida healthcare policies. This position requires a high level of organization, consistency, and accountability in a remote work environment. Essential Duties and Responsibilities: - Provide assistance to program clients with completion of paperwork and obtains employment verification documentation. - Support case managers to obtain attendance documentation. - Scan and log all client documentation in an accurate and timely manner. - Ensure activities and processes are in compliance with both company QA standards and applicable contractual standards. - Enter, transcribe, record, store, or maintain information in written, electronic and magnetic form relating to services, processes and quality systems. - Coordinate review activities as assigned by management. - Perform general office duties such as filing, copying, faxing and mail. - Perform other duties as may be assigned by management. Minimum Requirements - High school diploma or equivalent with 0 - 2 years of experience. - Florida residency preferred. - Florida Healthy Kids Program experience preferred. - Bilingual proficiency in both English and Haitian Creole required. Home Office Requirements: - Desktop or Laptop that runs Windows, Mac, or Linux (no Chromebooks or tablets). - OS for Windows - Current release of Windows 10 or newer. - OS for Mac - Big Sur (11.0.1+); MacOS (10.14) or newer. - OS for Linux - Ubuntu (18.04). - Connectivity to the internet via either Wi-Fi or RJ-45 connection for wired network connection to home router (no mobile hotspots). - Internet speed of 25mbps or higher required (you can test this by going to ******************* - USB plug and play wired headset with a microphone (no Bluetooth, AirPods or wireless gaming headsets). - Must currently and permanently reside in the Continental US. - Must have a camera EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 17.00 Maximum Salary $ 18.50
$39k-71k yearly est. Easy Apply 9d ago
QA QMS Associate
Cipla Ltd.
Quality assurance specialist job in Fall River, MA
Job Title QA QMS Associate Organization Name InvaGen Pharmaceuticals, Inc. Fall River, MA Shift General (8:30AM - 5:00PM) Employment Type Full Time Salary Range (Base/salary) $74,600 - $95,000 Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid family leave, employee discounts, and other benefits. Purpose The QA QMS Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals Inc. Fall River Facility. Responsibilities/ Accountabilities The essential and typically expected job duties for this position include but are not limited to the following: * Assist in the development, implementation, and maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (e.g., FDA, ). * Maintain and ensure the proper documentation of all quality systems and records. * Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work instructions, and other quality documents are up to date and correctly implemented. * Assist in the collection, analysis, and reporting of quality data (e.g., quality metrics, CAPA (Corrective and Preventive Action) reports, audit findings). * Support investigations of deviations, non-conformances, and customer complaints, ensuring appropriate follow-up and resolution. * Provide training and guidance to employees on QMS-related processes and regulatory requirements. * Ensure that the company remains compliant with all regulatory requirements (e.g., FDA, ICH, EMA). * Support risk assessments and help mitigate any potential quality risks to product safety and compliance. * Familiar with pharmaceuticals operation (preferably MDI) to ensure required compliance. * Familiar with TrackWise applications for handling Deviation and CAPA. * Prepare and review the investigation related to deviation, OOS, market complaints and microbiological failure. * Prepare and review the trend related to various QMS elements like Deviations, CAPA, Change Request and Environmental monitoring etc. * Preparation and review of the Annual Product Quality Review. * Fulfil the requirement of regulatory submission while closely working with regulatory teams. * Prepare and review risk assessment (FMECA) for various facility, equipment, process and particular event etc. * Prepare and review elemental impurities risk assessment and nitrosamine related risk assessment. * Prepare audit reports, documenting findings, and provide actionable recommendations for improvement. * Other duties as reasonably aligned with this role. Education Qualifications The ideal candidate's minimum qualifications will include: * Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is required. * A bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or a related field preferred. * A master's degree in a field to study relevant to the position is preferred. Experience Minimum of 3 years of experience in MDI or combination products is preferred. Skills/ Competencies * Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications. * Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals. * Effective interpersonal relationship skills and the ability to work in a team environment. * Proficiency in the English language to include usage, spelling, grammar, and punctuation. * Must have current Good Manufacturing Practices (cGMP) knowledge. * Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed. * Must have strong organization and leadership skills (written, verbal, and presentation). * Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines. Physical Requirements * This role works in a current Good Manufacturing Practice (cGMP) office, laboratory and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc. * Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required. * Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period may be required. * Relocation negotiable. * Must be willing to work long hours and some weekends based on a relevant business need, if required. GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. EEO Statement: Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
$74.6k-95k yearly 18d ago
QA QMS Associate
Cipla
Quality assurance specialist job in Fall River, MA
Job Title QA QMS Associate Organization Name InvaGen Pharmaceuticals, Inc. Location 927 Currant Rd, Fall River, MA Shift General (8:30AM - 5:00PM) Employment Type Full Time Salary Range (Base/salary) $74,600 - $95,000 Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid family leave, employee discounts, and other benefits. Purpose The QA QMS Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals Inc. Fall River Facility. Responsibilities/ Accountabilities The essential and typically expected job duties for this position include but are not limited to the following: · Assist in the development, implementation, and maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (e.g., FDA, ). · Maintain and ensure the proper documentation of all quality systems and records. · Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work instructions, and other quality documents are up to date and correctly implemented. · Assist in the collection, analysis, and reporting of quality data (e.g., quality metrics, CAPA (Corrective and Preventive Action) reports, audit findings). · Support investigations of deviations, non-conformances, and customer complaints, ensuring appropriate follow-up and resolution. · Provide training and guidance to employees on QMS-related processes and regulatory requirements. · Ensure that the company remains compliant with all regulatory requirements (e.g., FDA, ICH, EMA). · Support risk assessments and help mitigate any potential quality risks to product safety and compliance. · Familiar with pharmaceuticals operation (preferably MDI) to ensure required compliance. · Familiar with TrackWise applications for handling Deviation and CAPA. · Prepare and review the investigation related to deviation, OOS, market complaints and microbiological failure. · Prepare and review the trend related to various QMS elements like Deviations, CAPA, Change Request and Environmental monitoring etc. · Preparation and review of the Annual Product Quality Review. · Fulfil the requirement of regulatory submission while closely working with regulatory teams. · Prepare and review risk assessment (FMECA) for various facility, equipment, process and particular event etc. · Prepare and review elemental impurities risk assessment and nitrosamine related risk assessment. · Prepare audit reports, documenting findings, and provide actionable recommendations for improvement. · Other duties as reasonably aligned with this role. Education Qualifications The ideal candidate's minimum qualifications will include: · Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is required. · A bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or a related field preferred. · A master's degree in a field to study relevant to the position is preferred. Experience Minimum of 3 years of experience in MDI or combination products is preferred. Skills/ Competencies · Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications. · Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals. · Effective interpersonal relationship skills and the ability to work in a team environment. · Proficiency in the English language to include usage, spelling, grammar, and punctuation. · Must have current Good Manufacturing Practices (cGMP) knowledge. · Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed. · Must have strong organization and leadership skills (written, verbal, and presentation). · Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines. Physical Requirements · This role works in a current Good Manufacturing Practice (cGMP) office, laboratory and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc. · Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required. · Sitting at a desk and/or working at a computer or other “screen” 75% or greater of an 8-hour period may be required. · Relocation negotiable. · Must be willing to work long hours and some weekends based on a relevant business need, if required. GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. EEO Statement: Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
$74.6k-95k yearly 18d ago
Assurance Associate
Waldron H. Rand & Co
Quality assurance specialist job in Dedham, MA
Job DescriptionSalary: As an Assurance Associate at Waldron Rand, you will be responsible for applying basic areas of GAAP as necessary and documenting, validating, testing and assessing various control systems. This position may also be involved in compilations, reviews and agreed-upon procedure engagements. You will work closely alongside Partners, Managers, and Senior Associates as a member of the engagement team. Responsibilities Skillfully and accurately perform audits Review procedures as assigned by supervisors Prepare audit work papers and adjusting trial balances Analyze and compile financial statements into a written report to be presented to clients and coworkers Continuously foster relationships with coworkers and clients Qualifications Bachelors degree in Accounting or a related business field 0-3 years experience Must be proficient in Microsoft Excel Self-starter that can manage their day and manage the results of the project Exceptional verbal and written communication and interpersonal skills Relevant work experience (e.g. internships, summer positions, school jobs) Demonstrated leadership, problem solving, and strong business acumen Ability to prioritize tasks, work on multiple assignments, and manage ambiguity Ability to work both independently and as part of a team with professionals at all levels About Waldron Rand Success starts here. Hiring outstanding people is essential to providing the best results for our clients. We take responsibility for fostering talent, building knowledge and skill, and ensuring that professional development is happening every day. Our team-service approach maximizes learning opportunities and exposes staff to the wide-range of accounting, auditing, tax, and business advisory services. The Firms practice of having a member of the leadership team actively involved in all engagements ensures that staff members work directly with leadership from day one, gaining unsurpassed training, experience, and visibility. Waldron Rand is the oldest practicing accounting firm in the country. The Firms successful continuity is a direct result of our people and our commitment to continual advancement of the industry. Our progressive culture invites creativity and innovation into the practice of public accounting. It is the union of our technical skill and forward thinking that makes Waldron Rand a great place to work. Join Us.
$51k-74k yearly est. 6d ago
Food Quality Assurance Assistant
Gategroup
Quality assurance specialist job in Boston, MA
We're looking for motivated, engaged people to help make everyone's journeys better. This position is responsible for the oversight of all HACCP logs in the Hot Foods Production ensuring that the logs are completed as per company policies and procedures. The position is also responsible for ensuring that all FDA processes are followed. Annual Hiring Range/Hourly Rate: $21.50 - $22.00 Benefits Paid time off 401k, with company match Company sponsored life insurance Medical, dental, vision plans Voluntary short-term/long-term disability insurance Voluntary life, accident, and hospital plans Employee Assistance Program Commuter benefits Employee Discounts Free hot healthy meals for unit operations roles Main Duties and Responsibilities: Conducts temperature checks on products and ensures that all HAPPC, and FDA rules and regulations are followed along with managing the units log books. Performs quality checks in the Hot Food kitchen to ensure that the specifications of the customer are followed Ensures food produced in the Hot Foods is checked for temperature and placed in the refrigeration system per company policy Checks temperature of food prior to moving the food into the refrigeration system Randomly checks temperature of foods to verify that company policies are followed Monitors personal hygiene Supports customer audits and government audits to meet compliance Monitors company policies and procedures and notifies management of issue if they arise Responsible for safety, quality and compliance to customer specification Monitors equipment for cleanliness and sanitation Completes HACCP logs Communicates product deviation to the unit production manager immediately Ensures proper color code are applied to the product Qualifications Education: High School graduate or equivalent with experience in related discipline required Work Experience: In-Flight catering experience is highly desired Experience in a customer service environment is preferred Technical Skills: (Certification, Licenses and Registration) ServSafe training and certification required once hired Language / Communication Skills: Excellent oral and written communication skills Job Dimensions Geographic Responsibility: Unit Type of Employment: Full time Travel %: None Exemption Classification: Non-exempt Internal Relationships: Hot Food kitchen External Relationships: N/A Work Environment / Requirements of the Job: Regularly, stands, bends, lifts, and moves intermittently during shifts of 10+ hours. In a normal production kitchen facility there may be physical discomfort due to temperature and noise. Must be able to lift, push, pull and move product, equipment, supplies, etc., in excess of twenty-five (25) pounds. Detail oriented Strong organizational skills, able to prioritize responsibilities and multi-task Strong interpersonal skills, interact well with multiple departments as required Able to work with little supervision Organization Structure Direct Line Manager (Title): QA/Manager/Production Manager Dotted Line Manager (Title, if applicable): N/A Number of Direct Reports: 0 Number of Dotted Line Reports: 0 Estimated Total Size of Team: 1 gategroup Competencies Required to be Successful in the Job: Thinking - Information Search and analysis & problem resolution skills Engaging - Understanding others, Team Leadership and Developing People Inspiring - Influencing and building relationships, Motivating and Inspiring, Communicating effectively Achieving - Delivering business results under pressure, Championing Performance Improvement and Customer Focus Demonstrated Values to be Successful in the Position Employees at gategroup are expected to live our Values of Excellence, Integrity, Passion and Accountability. To demonstrate these Values, we expect to observe the following from everyone: We treat each other with respect and we act with integrity We communicate and keep each other informed We put our heads together to problem solve and deliver excellence as a team We have passion for our work and we pay attention to the little details We foster an environment of accountability , take responsibility for our actions and learn from our mistakes We do what we say we will do, when we say we are going to do it We care about our coworkers, always taking an opportunity to make someone's day better The above statements are intended to describe the general nature and level of work being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Management reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. gategroup is an equal opportunity employer committed to workforce diversity. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status or other category under applicable law. For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: **************************************************************** We anticipate that this job will close on: 12/29/2025 For California Residents, please clic k here to view our California privacy notice. If you want to be part of a team that helps make travel and culinary memories, join us!
$21.5-22 hourly Auto-Apply 33d 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
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 2d ago
Documentation Specialist-I
Artech Information System 4.8
Quality assurance specialist job in Boston, MA
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Experience: 1 to 3 years Required Skills: Strong organizational skills Attention to detail Ability to work cross-functionally Ability to organize work to meet deadlines Qualifications Education: High School Diploma and 1-3 years administrative/professional experience Experience with Microsoft Office products Additional Information For more information, Please contact Sneha Shrivastava ************
$44k-74k yearly est. 6h ago
QA Documentation Control Associate
Cipla Ltd.
Quality assurance specialist job in Fall River, MA
NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Document Control Associate FLSA Classification: Full-Time, Professional Work Location: Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM (May vary based on business needs) Reports To: QA QMS Lead Salary Range: $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible for managing controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, including creation, review, approval, distribution, and archival. JOB DESCRIPTION The QA Document Control Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders within the Quality. The essential and typically expected job duties for this position include but are not limited to the following: * Maintain the Documentation Control Room. * Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. after proper verification ensuring GDP. * Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. to cross functional department based on requirements. * Scan the document and keep them with proper naming. * Arrange all the documents with proper naming and proper tracking within documentation control room. * Train staff on document control procedures and Good Documentation Practices. * Maintain the accessories/day to day item required to maintain the documentation control room. * Support internal and external audits by providing accurate documentation packages. * Manage controlled documents such as SOPs, batch records, validation protocols, and specifications. * Send the document to outside agencies after proper scanning. * Control the issuance, tracking, retrieval, and final reconciliation of all site-critical logbooks for equipment and controlled areas. * Enforce strict adherence to Data Integrity principles (ALCOA+) and GxP documentation practices during all processing steps. * Assist in the preparation and execution of internal and external audits by efficiently locating and retrieving requested controlled documentation. * Involve in department QMS such as deviation, CAPA, Change Control, APQR preparation. * Any other work assigned by Operation Lead, QMS Lead, Head Unit Quality Assurance and Quality Head. EDUCATION AND EXPERIENCE QUALIFICATIONS * Bachelor's degree industrial management or related field of study from an accredited college/university is required for this position. * Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment. * Experience in MDI preferred. KNOWLEDGE, SKILLS, AND ABILITIES * Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications. * Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals. * Effective interpersonal relationship skills and the ability to work in a team environment. * Proficiency in the English language to include usage, spelling, grammar and punctuation. * 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 multitask and prioritize tasks with strict deadlines. GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. EEO Statement: Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
$64.3k-77.7k yearly 8d ago
QA Documentation Control Associate
Cipla
Quality assurance specialist job in Fall River, MA
NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Document Control Associate FLSA Classification: Full-Time, Professional Work Location: Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM (May vary based on business needs) Reports To: QA QMS Lead Salary Range: $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible for managing controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, including creation, review, approval, distribution, and archival. JOB DESCRIPTION The QA Document Control Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders within the Quality. The essential and typically expected job duties for this position include but are not limited to the following: Maintain the Documentation Control Room. Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. after proper verification ensuring GDP. Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. to cross functional department based on requirements. Scan the document and keep them with proper naming. Arrange all the documents with proper naming and proper tracking within documentation control room. Train staff on document control procedures and Good Documentation Practices. Maintain the accessories/day to day item required to maintain the documentation control room. Support internal and external audits by providing accurate documentation packages. Manage controlled documents such as SOPs, batch records, validation protocols, and specifications. Send the document to outside agencies after proper scanning. Control the issuance, tracking, retrieval, and final reconciliation of all site-critical logbooks for equipment and controlled areas. Enforce strict adherence to Data Integrity principles (ALCOA+) and GxP documentation practices during all processing steps. Assist in the preparation and execution of internal and external audits by efficiently locating and retrieving requested controlled documentation. Involve in department QMS such as deviation, CAPA, Change Control, APQR preparation. Any other work assigned by Operation Lead, QMS Lead, Head Unit Quality Assurance and Quality Head. EDUCATION AND EXPERIENCE QUALIFICATIONS Bachelor's degree industrial management or related field of study from an accredited college/university is required for this position. Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment. Experience in MDI preferred. KNOWLEDGE, SKILLS, AND ABILITIES Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications. Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals. Effective interpersonal relationship skills and the ability to work in a team environment. Proficiency in the English language to include usage, spelling, grammar and punctuation. 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 multitask and prioritize tasks with strict deadlines. GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. EEO Statement: Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
$64.3k-77.7k yearly 8d ago

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How much does a quality assurance specialist earn in New Bedford, MA?

The average quality assurance specialist in New Bedford, MA earns between $54,000 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 New Bedford, MA

$78,000

$54,00010%

$78,000Median

$114,00090%

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Quality Assurance Specialist New Bedford, MA Jobs

Quality assurance specialist jobs in New Bedford, MA

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Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in New Bedford, MA?