GelSight: Director of Compliance and Quality Anzu PartnersGelSight: Director of Compliance and QualityWaltham, MAFull timeLead investigations into significant quality issues related to product and material including partnering with Product Management for MRB (Material Review Board) reviews and dispositions, identification of root causes, and development of appropriate corrective and preventive actions. Lead a Quality Team and guide the organization to ensure the design, implementation, and continuous improvement of quality system supports effective product development, manufacturing, and fulfilment across the product lifecycle.
Administrative Assistant Apidel TechnologiesAdministrative AssistantBoston, MAContractorA high school diploma or equivalent from an accredited institution with the ability to comprehend, communicate and respond to instructions, orders, signs, notices, inquiries, etc. in English and 5 years of project administration or coordination duties supporting a large department or group may be substituted for the degree requirement. Available to work as per assignment by the MBTA twenty-four (24) hours per day, seven (7) days per week as directed by supervisory staff for severe weather conditions, emergencies or any other circumstances that may potentially impact service or the safety of service.
Lead Quality Engineer HitachiLead Quality EngineerSouth Boston, MassachusettsIf you are passionate about data-driven decision-making, problem-solving, and developing world-class quality systems, we invite you to help shape the future of sustainable energy with Hitachi Energy. As part of our recruitment process, Hitachi Energy uses digital and automated tools, including Al-supported solutions, to assist with activities such as application screening, job matching, and interview scheduling.
GMP Compliance Manager (Devens, MA) The Facilities GroupGMP Compliance Manager (Devens, MA)MACSI International Inc, founded in 1989, provides integrated building services to clients in real estate, property management, pharmaceuticals, telecommunications, higher education, manufacturing, and insurance. This position ensures that cleaning activities, employee training, documentation practices, and quality systems comply with current Good Manufacturing Practices (cGMP), site procedures, and client requirements.
Senior Director, Pharmacovigilance (PV) Sciences Keros TherapeuticsSenior Director, Pharmacovigilance (PV) SciencesLexington, MA$245,000–$302,000 / yearLead and manage all medical safety and risk management related projects including planning, tracking and execution; provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting; lead initiatives from the scientific and PV regulation perspective such as inspection readiness, and launch readiness. The Senior Director, PV Sciences is responsible for safety surveillance and aggregate safety reports and works with PV physicians for signal/risk management for Keros products to support product safety and compliance with global drug safety regulations and functional procedures and provide vendor oversight to PV vendors.
Director of Engineering, Energy Storage SOLV Energy LLCDirector of Engineering, Energy StorageMARemote$170,074–$226,199 / yearFoster effective communication and collaboration between the Energy Storage Engineering group and cross-functional teams, including internal and external engineers, business development managers, project managers, pre-construction managers, procurement specialists, schedulers, estimators, and construction teams. In addition, candidate introductions or resumes can only be submitted to our internal talent acquisition recruiting team if a signed vendor agreement is already on file and the third-party recruiter or agency has received formal instructions from our internal talent acquisition team to submit candidates for a particular job posting.
Quality Associate BiocytogenQuality AssociateWaltham, MassachusettsEvent Tracking: Assist in logging, tracking, and following up on Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls to ensure investigations and facility modifications are properly documented and resolved within timelines. Must be highly proficient in Microsoft Office Suite (Word formatting, Excel data management) and demonstrate the ability to quickly master new electronic tracking systems and document control software.
Legal Specialist III, BD/VC Transaction Boston Scientific CorpLegal Specialist III, BD/VC TransactionMarlborough, MATracking and managing key transactions and legal support timelines, including cross-functional work with treasury, accounting and senior leaders to prepare and document funding commitments and disbursements, as well as tracking requests/responses from governmental authorities (e.g., FTC requests/inquiries). The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
New2nd shift - GMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649 Vertex Pharmaceuticals2nd shift - GMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649Boston, Massachusetts$65–$70 / hourFull timeAgreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. Job Description: The Quality Shop Floor Specialist is responsible for the floor quality oversight of the production of autologous cell and gene therapy product in a controlled cGMP cleanroom environment.
NewGMP Operational Quality Sr Specialist (Batch Record Review) (Contract) 649-2 Vertex PharmaceuticalsGMP Operational Quality Sr Specialist (Batch Record Review) (Contract) 649-2Boston, Massachusetts$65–$70 / hourFull timeAgreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. Job Description: The operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT.
NewGMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649-1 Vertex PharmaceuticalsGMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649-1Boston, Massachusetts$65–$70 / hourFull timeAgreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. Job Description: The Quality Shop Floor Specialist is responsible for the floor quality oversight of the production of autologous cell and gene therapy product in a controlled cGMP cleanroom environment.
Senior Manager, Investigations, Diligence, and Compliance - Specialist Kroll, LLCSenior Manager, Investigations, Diligence, and Compliance - SpecialistBoston, MA$90,000–$200,000 / yearPlan and manage a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client) investigations, insider risk compliance assessments, consulting projects and forensic matters, with the support of Kroll's expert resources. The Senior Manager will develop and manage investigations and consulting cases, including client relationships, proposals, consulting and project management, and will have responsibility for quality and case completion and follow-up.
Senior Manager, Software Device Quality 3316 Takeda Development Center AmericasSenior Manager, Software Device QualityLexington, MassachusettsThe Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle - from design and development through manufacturing, distribution, and post-market support. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Mechanical Project Engineer DRAGADOSMechanical Project EngineerBoston, MA$85,000–$130,000 / yearWhite Contracting Company's Mechanical Division is seeking a driven and detail-oriented Mechanical Project Engineer to support the delivery of complex HVAC and mechanical construction projects throughout Greater Boston. Bachelor's degree in Construction Management, Mechanical Engineering, Civil Engineering, or a related field - OR - 3+ years of hands-on experience in mechanical or HVAC construction.
Mechanical Project Engineer DragadosMechanical Project EngineerBoston, Massachusetts$85,000–$130,000 / yearWhite Contracting Company's Mechanical Division is seeking a driven and detail-oriented Mechanical Project Engineer to support the delivery of complex HVAC and mechanical construction projects throughout Greater Boston. Bachelor's degree in Construction Management, Mechanical Engineering, Civil Engineering, or a related field — OR — 3+ years of hands-on experience in mechanical or HVAC construction.
Corporate Governance Specialist Total SuccessCorporate Governance SpecialistBoston, MAWe are looking for an experienced Corporate Governance Specialist to support board governance, legal department operations, regulatory coordination, and executive-level records management for a mission-driven financial services organization in Boston. This role is ideal for someone with experience supporting a Board of Directors, managing board materials and minutes, coordinating committee meetings, handling confidential documents, and working in a regulated environment.
Director, Manufacturing ReplimuneDirector, ManufacturingFramingham, Massachusetts$188,500–$243,500 / yearReporting to the Senior Director of Manufacturing, the incumbent works closely with internal stakeholders (Operations, Engineering, Validation, Facilities, Quality Control and Quality Assurance) to ensure an aseptic program that adheres to contamination control strategy (CCS) and focuses on continuous improvement including providing support for GMP document management as part of day-to-day operations. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
Senior Quality Systems Engineer Access VascularSenior Quality Systems EngineerBillerica, MA$93,000–$160,000 / yearThis role helps oversee our Quality Management System and provides Quality Engineering support across Operations, working closely with a small, hands-on team under AVI's QMS and FDA QMSR requirements. Proven track record with implementing, evolving, and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971.
Environmental, Health, and Safety Specialist Straumann Holding AGEnvironmental, Health, and Safety SpecialistAndover, MA$92,000–$112,000 / yearThe position independently manages assigned EHS programs and partners with all departments to ensure regulatory compliance, drive continuous improvement, reduce environmental impacts, and foster a proactive safety culture. We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
Training Associate Teleflex IncTraining AssociateChelmsford, MA$56,500–$79,100 / yearThe Training Associate supports the Quality Management System (QMS) training program by administering training assignments, maintaining training records, monitoring training compliance, and supporting training processes related to controlled document changes. The pay range for this position at commencement of employment is expected to be between $56,500 - $79,100 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.