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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 4d ago
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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 1d ago
Bioconjugation Quality Assurance Supervisor
Veranova
Quality assurance specialist job in Devens, MA
Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
This role provides Quality Assurance (QA) support for bioconjugation processes and GMP manufacturing of APIs and intermediates, ensuring compliance with global quality standards and regulatory requirements. This role will oversee key quality activities including deviation management, change control, batch record review, and product disposition, while driving continuous improvement and compliance initiatives. As a leader within the Quality Operations team, the QA Supervisor will guide and develop team members, collaborate across functions, and shape the strategic direction of quality within the organization.
Core Responsibilities:
Lead Quality Assurance oversight for bioconjugation manufacturing, ensuring GMP production and release of conjugated APIs, linkers, and payloads meet client expectations, timelines, and quality standards.
Provide hands-on QA support on the production floor during conjugation, purification, and filling operations to ensure compliance with cGMPs, SOPs, and company policies.
Oversee the review and approval of deviations, change controls, CAPAs, batch records, specifications, and other controlled quality documentation.
Coach, mentor, and develop QA staff, providing guidance on quality systems, compliance practices, and real-time problem solving.
Drive operational excellence by aligning local QA initiatives with global objectives and promoting a culture of quality and compliance across the organization.
Support audits, investigations, and regulatory inspections, ensuring timely follow-up and continuous improvement in processes and systems.
Evaluate complex quality or cross-functional issues using a risk-based approach and ensure CDMO partners meet Quality Agreement and regulatory expectations.
Prioritize and allocate QA resources effectively to meet business demands and production schedules.
Serve as a key client interface for Quality topics, fostering strong relationships and clear communication on regulatory and quality matters.
Contribute to organizational quality strategy by participating in forums, continuous improvement initiatives, and talent development efforts.
Qualifications:
Required
Minimum 9 years of quality assurance (QA) experience in a GMP manufacturing setting, preferably within a CDMO or API/intermediate facility, with an undergraduate degree in engineering, science or related field; or a minimum 7 years of QA experience with a graduate degree in engineering, science or related field
Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements
Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
Proven ability to drive complex projects from initiation to completion, with strong analytical, problem-solving, and attention-to-detail skills.
Demonstrated experience working effectively both independently and in team settings, including prior people management or team leadership.
Excellent communication, interpersonal, networking, presentation, and influencing skills to build and lead cross-functional relationships.
Embodies and promotes Veranova's culture, fostering an inclusive, positive work environment and delivering exceptional business results.
Strong collaborative mindset with the ability to motivate, develop, and inspire others while effectively managing priorities and responsibilities.
Preferred
Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred. Familiarity with HPAPI handling and containment requirements a plus
Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc.
Salary Range: $125,000 - $140,000 annual base salary
Our Commitment:
Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .
$125k-140k yearly 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. 1d 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 11h ago
Embedded QA Engineer
Global Connect Technologies 4.4
Quality assurance specialist job in Westford, MA
Job Title: Embedded QA Engineer
Job Type: Full-Time
We are seeking an experienced Embedded QA Engineer to join our agile sprint team in Westford. The ideal candidate will be responsible for hands-on testing of embedded systems, including panels and fire systems, ensuring the delivery of high-quality software through both manual and automated testing. This role requires strong analytical and troubleshooting skills, along with the ability to collaborate effectively within a cross-functional team.
Key Responsibilities
Actively participate as a member of the agile sprint team.
Develop, configure, and execute test cases for embedded systems.
Automate new features and maintain existing automation scripts.
Interpret and validate requirements from feature documentation, diagrams, and Jira tickets.
Perform manual and automated testing of embedded features and assess their impact on overall system behavior.
Conduct white-box testing, compiled code debugging, and detailed log analysis.
Use Python scripting for automation development and troubleshooting.
Identify, reproduce, and escalate defects with detailed logs and reproduction steps.
Collaborate closely with development engineers during issue analysis, re-installation, and retesting cycles.
Proactively learn and adapt to new tools, frameworks, and team processes.
Work independently with minimal supervision while maintaining clear communication and accountability.
Qualifications
3-5 years of hands-on QA/testing experience in embedded systems.
Strong understanding of embedded architectures and system-level testing.
Experience with Atlassian tools (Jira, Confluence) for defect tracking and documentation.
Proficiency in Python scripting for automation and debugging.
Ability to analyze logs, validate fixes, and identify root causes.
Familiarity with white-box testing and compiled code debugging.
Excellent analytical, problem-solving, and communication skills.
Ability to work independently and collaboratively in a team-oriented environment.
Not required to be a full-time coder, but must have a solid grasp of technical and software concepts.
Preferred Skills
Experience with fire systems, life-safety systems, or other safety-critical domains.
Hands-on exposure to embedded hardware panels and system integration testing.
Familiarity with QA automation frameworks and test infrastructure in embedded environments.
$74k-105k yearly est. 5d ago
Environmental monitoring QC Associate
Planet Pharma 4.1
Quality assurance specialist job in Bedford, MA
Responsibilities:
• Perform environmental monitoring (EM) tasks for the aseptic environment, other controlled areas, and plant utility systems following specified instructions and techniques from Standard Operating Procedures (SOP), Training Material, and other GMP documents.
• Incubate and enumerate microbial growth on EM plates.
• Ensure all tasks are completed in a GMP compliant and safe manner.
• Document all tasks within LIMS or standard laboratory paper documentation utilizing GDP principles.
• Entry of information into logbooks as applicable for tasks per SOP.
• Partner and communicate with operations, manufacturing, facilities, and other site departments as required for support of operations and GMP processes.
• Actively participate in daily and weekly laboratory meetings.
• Accurately complete task management tools and handover communications.
• Perform general lab tasks including cleaning and equipment preparation.
• Maintain training for all required tasks.
• May assist in laboratory investigations with limited scope.
Requirements:
• Bachelor's degree with no experience, associate degree with 2+ years' experience, or High School Diploma [or Equivalent (GED)] with 4+ years' experience.
• Good oral, written, and interpersonal communication skills.
• Basic math skills and computer skills such as data entry, along with a high level of attention to detail.
• A demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task) and be able to meet objectives in a team-oriented environment.
• Must maintain aseptic qualifications
Shift is Sunday - Wednesday, 10 hour days, after a 3 month training period of Monday - Friday, 8 hour days
$41k-66k yearly est. 5d ago
Quality Engineer, Analytical Development and Quality Control
Vaxess Technologies
Quality assurance specialist job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Role
The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.
Key Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling.
Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities.
Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards.
Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation
Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records.
Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays.
Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.
Qualifications
Bachelor's degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1-3 years of relevant mechanical testing or QC experience, or a master's degree with applicable laboratory experience.
Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems.
Demonstrated proficiency in tensile, compression, shear, puncture, and force-displacement mechanical characterization.
Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products.
Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+).
Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation.
Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus.
Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
Commitment to collaborative work within interdisciplinary project teams.
At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to
******************
.
$69k-95k yearly est. 1d ago
Entry Level Mortgage Document Specialist
Northpoint Mortgage 3.5
Quality assurance specialist job in Danvers, MA
Northpoint Mortgage, selected as one of the Boston Globe's Top Places to Work three years' running, is a growing New England-based mortgage lender seeking to add an entry-level, full-time employee to our Danvers, MA office. In addition to a great working atmosphere, we offer competitive pay, benefits, and a gateway into an exciting industry. We are seeking a candidate in the Danvers, MA area, as this is an in-office position.
Responsibilities:
Reception: Answer phones and greet clients with the highest level of customer service
Communicate directly with operations staff and loan officers
Sort and organize mortgage loan documents, adhering to compliance deadlines
Review loan package documentation for discrepancies or omissions
Verify loan information for accuracy at time of disclosure
Ensure that all required regulatory, state and investor disclosures are included in disclosed packages
Loan Opening-- provide administrative support through the loan application process
Assist in special projects as needed by management
Skills needed:
Proficiency with Microsoft Office including Excel, Word, and Outlook
Excellent phone manner
Strong detail orientation with a solution-oriented demeanor
Multitasking & a strong sense of responsibility for tasks assigned
Ability to communicate comfortably with all levels of the organization
Post- Secondary education preferred
Compensation is commensurate with experience.
$34k-50k yearly est. 27d 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 5d ago
Home Health QA Coordinator
Acclaim Home Health
Quality assurance specialist job in Worcester, MA
Acclaim Home Health is seeking an experienced QA Coordinator to oversee and ensure the accuracy, compliance, and quality of clinical documentation in accordance with state, federal, and payer regulations. The QA Coordinator plays a critical role in supporting high-quality patient care by reviewing OASIS assessments, ensuring accurate coding, and promoting regulatory compliance and best practices across the organization.
Key Responsibilities
Review OASIS assessments for accuracy, completeness, and compliance with CMS guidelines
Ensure correct clinical coding (ICD-10) and documentation consistency
Identify trends, errors, and risk areas; provide feedback and education to clinical staff
Collaborate with clinicians, leadership, and billing to improve documentation quality and outcomes
Monitor compliance with Medicare Conditions of Participation and other regulatory requirements
Assist with audits (internal and external) and performance improvement initiatives
Stay current on OASIS updates, coding changes, and regulatory requirements
Qualifications
OASIS Certification required
Proven coding experience, including ICD-10 coding in a home health setting
Prior experience in home health quality assurance, clinical review, or utilization review preferred
Strong knowledge of Medicare regulations and home health compliance standards
Excellent attention to detail and analytical skills
Strong communication and collaboration skills
Ability to work independently and manage multiple priorities
Preferred Credentials
RN, LVN/LPN, or other licensed clinical background (preferred but not required, if applicable)
Previous experience with QA audits and performance improvement programs
Why Join Acclaim Home Health?
At Acclaim Home Health, we are committed to delivering exceptional patient-centered care while supporting our team members with a positive and professional work environment.
Acclaim Home Health is an Equal Opportunity Employer (EEO). We celebrate diversity and are committed to creating an inclusive environment for all employees.
$59k-86k yearly est. 3d 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 7d ago
Quality Assurance Associate
Pharmaron 4.5
Quality assurance specialist job in Woburn, MA
Quality Assurance Associate Salary: $65,000 to $75,000 per year FLSA Classification: Exempt Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit ******************
Job Overview:
The Quality Assurance Associate will work in a GxP compliant Bioanalytical CRO Laboratory and will be responsible for daily QA duties under the supervision of the Lead Quality Specialist. This onsite role will support the development, implementation, and maintenance of the Pharmaron (Boston) Lab Services Quality Management System.
Responsibilities:
* Perform administrative and support tasks to assist PLSB Head of Quality in maintaining all key Quality Systems including but not limited to; Document Control, Training and Qualification Management, Deviation and CAPA Management, Audits and Inspections, Equipment Qualification and Management, Archival and Records Management, and tracking and trending.
* Perform initial intake, documentation, notification, administrative review, tracking, filing, and completion support for records related to the above referenced quality systems.
* Ensure all records are indexed, labeled, tracked, and filed appropriately in paper and electronic format.
* Maintain robust cross-referencing tracking tools with required information to support Head of Quality review of trends, risks, issues, and gaps.
* Provide reports to Lead Quality Specialist of upcoming, outstanding, and incomplete tasks and events.
* Support PLSB technical and laboratory staff in navigating basic QA procedures and escalate issues to Head of Quality when appropriate.
* Assist Head of Quality on all assigned projects, including reconciliation and organization of legacy information for increased accuracy, reduced error, closure of historical gaps, and ease of access.
* Additional duties, as required
What We're Looking For:
We're seeking individuals who have strong communication skills with attention to detail who thrive in fast-paced environments.
* Bachelor's degree in science, preferably in biology or similar field (preferred)
* Two years of Quality Assurance experience within the pharmaceutical or biotechnology industry, in a regulated environment; GLP or other regulatory experience is desired
* ISO 9001:2015 Quality Systems experience, a plus
* Strong technical writing skills
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centred" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
* Insurance including Medical, Dental & Vision with significant employer contributions
* Employer-funded Health Reimbursement Account
* Healthcare & Dependent Care Flexible Spending Accounts
* 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
* 401k plan with generous employer match
* Access to an Employee Assistance Program
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#LI-JB1
$65k-75k yearly 32d 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. 1d 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. 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 4d 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 11h ago
Quality Assurance Associate
Pharmaron 4.5
Quality assurance specialist job in Woburn, MA
Job Description
Quality Assurance Associate
Salary: $65,000 to $75,000 per year
FLSA Classification: Exempt
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit ******************
Job Overview:
The Quality Assurance Associate will work in a GxP compliant Bioanalytical CRO Laboratory and will be responsible for daily QA duties under the supervision of the Lead Quality Specialist. This onsite role will support the development, implementation, and maintenance of the Pharmaron (Boston) Lab Services Quality Management System.
Responsibilities:
Perform administrative and support tasks to assist PLSB Head of Quality in maintaining all key Quality Systems including but not limited to; Document Control, Training and Qualification Management, Deviation and CAPA Management, Audits and Inspections, Equipment Qualification and Management, Archival and Records Management, and tracking and trending.
Perform initial intake, documentation, notification, administrative review, tracking, filing, and completion support for records related to the above referenced quality systems.
Ensure all records are indexed, labeled, tracked, and filed appropriately in paper and electronic format.
Maintain robust cross-referencing tracking tools with required information to support Head of Quality review of trends, risks, issues, and gaps.
Provide reports to Lead Quality Specialist of upcoming, outstanding, and incomplete tasks and events.
Support PLSB technical and laboratory staff in navigating basic QA procedures and escalate issues to Head of Quality when appropriate.
Assist Head of Quality on all assigned projects, including reconciliation and organization of legacy information for increased accuracy, reduced error, closure of historical gaps, and ease of access.
Additional duties, as required
What We're Looking For:
We're seeking individuals who have strong communication skills with attention to detail who thrive in fast-paced environments.
Bachelor's degree in science, preferably in biology or similar field (preferred)
Two years of Quality Assurance experience within the pharmaceutical or biotechnology industry, in a regulated environment; GLP or other regulatory experience is desired
ISO 9001:2015 Quality Systems experience, a plus
Strong technical writing skills
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centred" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
Insurance including Medical, Dental & Vision with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
401k plan with generous employer match
Access to an Employee Assistance Program
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#LI-JB1
$65k-75k yearly 2d 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 Associate
Actalent
Quality assurance specialist job in Waltham, MA
We are seeking a Quality Assurance Associate to support on-the-floor QA issues within the manufacturing suite. This role requires mitigating gaps and risks for all quality and GMP processes, running investigations for deviations, change controls, CAPAs, and out-of-specifications, as well as reviewing and authoring SOPs.
Responsibilities
* Support on-the-floor QA issues within the manufacturing suite.
* Mitigate gaps and risks for all quality and GMP processes.
* Run investigations for deviations, change controls, CAPAs, and out-of-specifications.
* Review and author SOPs.
Essential Skills Needed
* Quality assurance experience
* Document control
* Batch record review
* CAPA management
* Deviation handling
* Compliance with audits and quality systems management
Qualifications
* BS degree in a specific science with 3-5 years of experience
* Experience supervising or managing direct reports
* Support for GMP requirements and compliance
* Knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines
Pay and Benefits
The pay range for this position is $25.00 - $27.00/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 May 2, 2025.
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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$25-27 hourly 60d+ ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Lawrence, MA?
The average quality assurance specialist in Lawrence, MA earns between $53,000 and $110,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.
Average quality assurance specialist salary in Lawrence, MA
$76,000
What are the biggest employers of Quality Assurance Specialists in Lawrence, MA?
The biggest employers of Quality Assurance Specialists in Lawrence, MA are: