Quality assurance specialist jobs in Newburyport, MA - 561 jobs

A digital health technology company is seeking a Director of Regulatory Affairs and Quality Assurance to lead regulatory compliance and quality frameworks for their medical-grade digital health products. This role involves overseeing FDA submissions, ensuring quality management systems meet global standards, and mentoring a high-performing regulatory team. The ideal candidate will have a strong background in regulatory affairs, experience with medical devices, and the ability to thrive in a fast-paced environment. Competitive salary offered in Boston, MA. #J-18808-Ljbffr

Your mission The Commercial Quality Assurance Director will be based in Massachusetts and serve as the primary QA contact for commercial operations in the United States, maintaining close alignment with key partners in the United States and Europe. The position requires strategic leadership in developing and expanding a global Quality Management System, as well as extensive knowledge of GMP compliance and regulatory requirements. The Commercial Quality Assurance Director will also manage relationships with external partners, including CMOs, 3PLs, and distributors. The Commercial Quality Assurance Director will also oversee the quality of GMP development partners to ensure seamless integration across the product lifecycle. As we prepare for the launch of pritelivir in 2026, the Commercial Quality Assurance Director will play a critical role in supporting FDA inspection readiness and EMA submission activities while driving quality excellence across global operations. Lead the creation, review, and revision of SOPs to ensure commercial readiness and regulatory GMP compliance. Shape the evolution of the QMS to meet global commercial and regulatory GMP expectations. Implement recall procedures and perform mock recall to ensure recall procedures are adequate. Review, negotiate, maintain and manage quality agreements with CMOs, 3PLs, wholesalers and distributors. Serve as the primary QA contact for external commercial partners (e.g., CMOs, 3PLs, wholesalers, distributors). Develop and deliver training programs on commercial and GMP QA processes across all levels of the organization. Provide strategic oversight of GMP compliance across all outsourced manufacturing and packaging activities. Act as the QA liaison with internal stakeholders (e.g., Supply Chain, CMC, and Regulatory Affairs) and external service providers. Drive vendor qualification, audit strategy, and ongoing performance management. Lead / support internal and external audits, as required. Ensure inspection readiness for the FDA and support EMA submission activities within your area of responsibility. Prepare, review, and/or approve high-impact quality documentation, including batch records, deviations, CAPAs, change controls, product complaints and product quality reviews. Support product release processes and ensure timely QA support for supply chain operations. Drive continuous improvement initiatives within the commercial/GMP QA framework. Your profile Bachelor's, master's, or doctoral degree in a relevant scientific discipline (e.g., biology, chemistry, or pharmacy). Minimum 7 years of experience in biotech/pharma with exposure to commercial products. Deep understanding of FDA regulations (21 CFR Parts 210/211 and 600) and EU GMP (EudraLex, Volume 4) and global commercial quality standards. Proven experience in building and scaling QMS for commercial operations. Ideally, experience with computerized system validation in a GxP-regulated environment. Strong strategic thinking, communication, and stakeholder management skills. Detail-oriented with strong analytical and problem-solving abilities. Experience working in global regulatory environments and managing international QA operations is a plus. Ability to travel occasionally for audits, inspections, and team meetings. Close collaboration and alignment with the global QA team in Germany. Fluency in English. Why us? Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration. Development: We encourage people to grow and strongly support individual development and learning opportunities. Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life. Benefits: Competitive comprehensive benefit plan. #J-18808-Ljbffr

A biopharmaceutical innovator is seeking a PV Quality and Compliance Associate Director. This critical role focuses on ensuring regulatory compliance in pharmacovigilance activities. The successful candidate will lead the development of the Quality Management System and manage audits. Requires a strong background in PV regulations, leadership skills, and experience in compliance initiatives. The position offers a competitive salary range of $150,000-$200,000 based on experience and location in Greater Boston. #J-18808-Ljbffr

A state health department is seeking a Chief Quality Officer to lead hospital quality initiatives and ensure regulatory compliance. Candidates must have a valid RN license in Massachusetts and extensive experience in quality/risk management, including managerial roles. The position involves collaboration with clinical teams to implement effective quality improvement strategies and ensure patient safety across the hospital system. The role offers a salary range of $100,839.08 - $155,529.95 per year with full-time scheduling. #J-18808-Ljbffr

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 .

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

Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS applications during inspections and explaining compliance. Train management and onboard new users to the system. Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports. Support Quality System Vendor Audits as a Business SME. Support KPI reporting and lead commitment meetings. Manage regular system updates/releases and assess and recommend new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/ or modified. Investigate, escalated, and resolve issues identified on system. Execute/facilitate regression testing associated with system upgrades/project implementation. Participate in user forums/industry groups to garner best practice and represent Alkermes. Identify opportunities for continuous improvement and prioritize and manage associated change to completion. Qualifications Bachelor's degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems. Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following:TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently. The annual base salary for this position ranges from $141,000 to $146,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website:************************************* . #J-18808-Ljbffr

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.

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.

Immediate need for a talented Third Party Management Specialist/Quality Assurance Associate II (Scientific). This is a 06+ Months Contract opportunity with long-term potential and is located in Framingham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:25-95197 Pay Range: $35 - $48/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Role will work with some of the smaller vendors, will reach out to and worker. This is not a post market compliance role, this is on material compliance role - single use system, defects of materials, they'll reach out to supplier to conduct investigations. Key Requirements and Technology Experience: Skills-Material Compliance, Quality Operations, quality agreement, Change Notification, FDA. Must have a Bachelor's degree + 6 years of applicable experience. Manager is open to all levels of experience Previous experience with Veeva, quality agreements, supplier compliance, and supplier change notifications preferred. Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

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 **********************

A leading global energy management company seeks a dedicated individual for a software quality role to manage best practices and ensure quality processes. This position focuses on improving customer satisfaction through software quality initiatives and requires a strong background in software development over 15 years. The candidate should have extensive knowledge of software methodologies and effective leadership skills to drive change in software systems. This is a full-time role based in Boston, MA, which offers competitive compensation and a comprehensive benefits package. #J-18808-Ljbffr

Function: Legal / Compliance Workplace Type: Remote Schedule: Full-time Reports to: Head of Compliance Virtual Schools Pearson Virtual Schools provides full-time, online K-12 public schools and district partnership solutions across the United States. Through the Connections Academy model, we deliver a comprehensive, turnkey online education solution to school districts and charter school boards nationwide. About the Role The Senior Compliance Specialist plays a key role in ensuring Pearson Virtual Schools and its partner schools operate in compliance with applicable education laws and regulations. Reporting to the Head of Compliance, you will serve as a subject matter expert in assigned compliance areas, providing guidance to internal teams and partner schools on regulatory requirements that impact school operations, policies, and services. This is a hands‑on, analytical role suited to someone who enjoys legal research, interpretation of legislation, and translating complex regulatory requirements into practical guidance. Key Responsibilities Conduct legal research and provide compliance guidance to internal business teams and partner schools Respond to inquiries related to day‑to‑day school operations and compliance with state laws and regulations Analyze and interpret new legislation, preparing written summaries outlining impacts on business and school operations Collaborate cross‑functionally with teams including School Operations, State Policy & Partnerships, Curriculum, and Technology Draft and update school policies to ensure alignment with regulatory requirements Review and revise school handbooks to reflect current legislation Own and deliver special projects aligned to business objectives Develop and maintain School Safety and Emergency Operations Plans Respond to public records requests received by partner schools Perform additional duties as assigned Required Skills, Experience & Competencies Qualifications & Experience Bachelor's degree required 5-7 years' experience in a law firm, legal department, or equivalent professional setting Skills & Capabilities Strong ability to analyze and interpret complex legal and regulatory concepts Excellent legal research and writing skills Strong analytical, problem‑solving, and critical thinking abilities Highly detail‑oriented, organised, and able to manage multiple priorities Proven ability to work independently while knowing when to elevate issues Comfortable operating in a fast‑paced, evolving environment Strong proficiency in Microsoft Office applications Compensation at Pearson is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific location. As required by the California, Colorado, Hawaii, Illinois, Maryland, Minnesota, New Jersey, New York State, New York City, Vermont, Washington State, and Washington DC laws, the pay range for this position is as follows: The minimum full‑time salary range is between $80,000 - $85,000. This position is eligible to participate in an annual incentive program, and information on benefits offered is available here. Applications will be accepted through January 9th, 2026. This window may be extended depending on business needs. Pearson is an Equal Opportunity Employer and a member of E‑Verify. Employment decisions are based on qualifications, merit and business need. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, age, national origin, protected veteran status, disability status or any other group protected by law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by emailing ******************************************. #J-18808-Ljbffr

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.

A leading biotechnology company in Boston is seeking an Associate Director, GMP Operational Quality to ensure compliance and quality oversight for commercial drug manufacturing. The role includes managing relationships with vendors, mentoring team members, and leading quality improvement initiatives. Candidates should possess strong knowledge of cGMPs, a scientific degree, and extensive experience in quality assurance and project management. This position offers a hybrid work model and competitive compensation package. #J-18808-Ljbffr

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 ****************** .

Job Title: Quality Assurance AssociateJob Description We are seeking a dedicated Quality Assurance Associate to support on-the-floor QA issues within our manufacturing suite. You will play a crucial role in mitigating gaps and risks for all quality and GMP processes, and will run investigations for deviations, change controls, CAPAs, and out-of-specifications. Additionally, you will review and author SOPs to ensure compliance with industry standards. Responsibilities * Support on-the-floor QA issues within the manufacturing suite. * Mitigate gaps and risks for all quality and GMP processes. * Conduct investigations for deviations, change controls, CAPAs, and out-of-specifications. * Review and author Standard Operating Procedures (SOPs). Essential Skills * Proficiency in quality assurance and document control. * Experience with batch record review, CAPA, and deviation management. * Knowledge of compliance, audits, and quality systems management. * Familiarity with cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines. Additional Skills & Qualifications * Bachelor's degree with 3-5 years of experience. * Experience supervising or managing direct reports. * Capability to support GMP requirements and compliance. Work Environment The role involves working with a team of 3-4 individuals. It is a first shift, Monday to Friday business casual environment, with occasional weekend work required. The company values hard-working individuals who are great team players. Enjoy contractor perks such as participation in all company events, a fully stocked kitchen, company-provided lunches twice a week, and access to an on-site gym that's open 24/7. Job Type & Location This is a Contract to Hire position based out of Waltham, MA. Pay and Benefits The pay range for this position is $43.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Waltham,MA. Application Deadline This position is anticipated to close on Jan 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.

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

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: 01/16/2026 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!