Quality Control Specialist I - Raw Materials (Contract)

Join elevatebio as a Quality Control Specialist I focused on raw materials in a contract role. In this position, you will play a crucial role in ensuring the quality and compliance of raw materials used in our innovative biomanufacturing processes. Your attention to detail and commitment to excellence will contribute to the overall success of our operations.

About the Role New England Donor Services is seeking a Quality Systems Specialist I in Waltham. This entry-level position supports the organization’s commitment to quality by helping to develop, implement, and maintain quality systems that meet industry regulations and standards. What You Will Do Assist with the creation and improvement of quality systems and processes Help ensure compliance with relevant regulations and industry standards Support ongoing maintenance and documentation of quality procedures

ElevateBio develops and manufactures advanced therapies, working with partners from early stages through to commercialization. The company combines a range of technologies, services, and manufacturing expertise to help advance new therapies efficiently. Role overview The Quality Assurance Validation Specialist I will join the QA Validation Group and focus on Commissioning and Qualification (CQV) activities for quality control laboratories, manufacturing suites, and related equipment. This position supports quality assurance within a cGMP environment. Main responsibilities Oversee QA activities for CQV processes in cGMP manufacturing facilities and quality control labs. Manage QA oversight for periodic reviews and requalification programs. Review Computerized Maintenance Management System (CMMS) records for asset management, including asset release, database requests, and work orders. Provide QA oversight for quality events related to validation and engineering, such as deviations and CAPAs. Contribute feedback as part of cross-functional teams on inspection readiness activities. Author and review Standard Operating Procedures (SOPs) in Veeva. Requirements Strong understanding of Commissioning and Qualification processes for laboratory and manufacturing environments, including equipment and instrumentation. This role is based in Waltham, Massachusetts.

About Anduril Industries Anduril Industries develops advanced defense technology for the U.S. and allied militaries. The company focuses on delivering autonomy, artificial intelligence, computer vision, sensor integration, and communication systems. Anduril’s products run on Lattice OS, a platform that turns large data streams into a 3D command and control interface. The team aims to bring new capabilities to the field in months rather than years. Role Overview: Material Operations Specialist Based in Waltham, Massachusetts, the Material Operations Specialist works alongside Field Operations leadership to ensure the right hardware reaches each mission. This position calls for strong problem-solving skills, attention to detail, and the ability to work well with others. Success in this role relies on knowledge of logistics, hardware operations, and cross-functional project management. Main Responsibilities Assist with receiving, identifying, and documenting inventory.

This Associate II, Quality Control role at elevatebio focuses on maintaining rigorous quality standards for products and processes. The position is located in Waltham, Massachusetts and supports the company's commitment to compliance and operational excellence. Key Responsibilities Perform quality assessments to ensure both compliance and consistency across operations. Implement established quality control procedures throughout daily activities. Collaborate with colleagues from various departments to address regulatory requirements. Identify opportunities for process improvement and contribute to strengthening quality systems. Requirements Strong analytical skills for reviewing data and evaluating processes. Close attention to detail when handling quality documentation and procedures. Background in regulated environments is considered valuable.

Join Artech Information Systems LLC as a Scientist I, where you will embark on a scientific journey in a dynamic and supportive environment. This entry-level position is an excellent opportunity for recent graduates or those new to the field of science to apply their knowledge and skills in a practical setting. You will engage in research, data analysis, and collaboration with seasoned professionals, contributing to innovative projects that make a difference.

At Xometry (NASDAQ: XMTR), we empower the industries of today and tomorrow by connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with the essential tools to expand their businesses while providing Fortune 1000 companies seamless access to global manufacturing capabilities.We are on the lookout for dynamic Quality Engineers to join our team and support our rapid growth. Are you someone who thrives in challenging environments? Do you aspire to revolutionize an industry? If your strength lies in prioritizing tasks and communicating effectively, then this role could be your next great adventure.As a Quality Assurance Engineer, you will collaborate with a fast-paced team of engineering experts to address quality assurance challenges for customized parts. You will also assist the Senior Director in developing our quality systems in line with corporate policies and AS9100 standards.

The Elevator PitchEvolv Technology is dedicated to enhancing global safety through innovative, AI-driven security solutions. We are looking for a meticulous and commercially adept Senior Contracts Manager to join our Legal Team in its mission to expand the business while fostering a culture of creativity, ongoing learning, and adherence to compliance.This is an exceptional opportunity to contribute to an extraordinarily talented Legal Team supporting a rapidly growing, mission-focused public company that operates at the forefront of physical security and state-of-the-art technology. In this critical role, you will oversee the complete lifecycle of commercial contracts, ensure compliance with industry regulations, and assist our sales and procurement teams in executing deals efficiently and responsibly. You will collaborate with stakeholders across various departments, and your insights and contributions will have an immediate impact due to the size of both the Legal Team and the company.The ideal candidate merges a solid understanding of the contracting and go-to-market processes with a practical business perspective, a keen interest in emerging technologies, and a commitment to facilitating responsible innovation. This position is perfectly suited for someone who flourishes at the intersection of law, business, and process optimization, and is eager to grow alongside Evolv.

At Crescent Biopharma, we strive to revolutionize oncology by delivering pioneering therapies to cancer patients. Our pipeline features innovative treatments, including a leading PD-1 x VEGF bispecific antibody and advanced antibody-drug conjugates (ADCs). By harnessing various modalities and well-established targets, we are dedicated to expediting the development of potentially transformative therapies, whether as standalone treatments or in combination regimens, to address a multitude of solid tumors. To learn more about our mission, visit us at crescentbiopharma.com and connect with us on LinkedIn and X.We are currently seeking an experienced Associate Director/Director of GMP Quality Assurance Operations. In this pivotal role, you will lead our Quality organization, providing essential oversight for GMP manufacturing activities related to our bispecific antibody and ADC programs. You will manage quality processes across the production of master cell banks, working cell banks, drug substances, and finished products within a highly outsourced development framework. Collaborating closely with the Senior Director of Quality and cross-functional teams, you will ensure compliance with phase-appropriate GMP standards, effectively implement quality systems, and maintain continuous inspection readiness to support our ambitious development timelines.

Join Acorn Product Development, a leading product engineering services firm, dedicated to empowering global companies through innovative engineering solutions. Our collaborative approach enables us to tackle complex engineering challenges, streamline supply chains, and optimize manufacturing and delivery processes. With our extensive expertise and established relationships, we assist clients in launching innovative, reliable, and cost-effective products that make a significant impact in their respective markets.We are currently seeking experienced Mechanical Engineers (contractors) to join our dynamic team in Waltham, MA. Local candidates are preferred.

Zenas BioPharma is a pioneering clinical-stage biopharmaceutical company dedicated to becoming a frontrunner in the development and commercialization of groundbreaking therapies aimed at treating autoimmune diseases. Our strategic approach combines the expertise of our seasoned leadership team with a focused product candidate acquisition strategy to identify, acquire, and develop globally impactful product candidates that can deliver exceptional clinical benefits to patients affected by autoimmune conditions. Currently, Zenas is advancing two late-stage molecules, obexelimab and orelabrutinib. Obexelimab, our leading candidate, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, crucial components in the B cell lineage, designed to inhibit the activity of specific cells involved in autoimmune disorders without depleting them. We believe that obexelimab’s innovative mechanism and self-administered, subcutaneous injection method will effectively address the pathogenic role of B cells in chronic autoimmune diseases. Orelabrutinib is a highly selective, CNS-penetrant oral Bruton’s Tyrosine Kinase (BTK) inhibitor that shows promise in managing compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our earlier-stage projects include a preclinical oral IL-17AA/AF inhibitor and a preclinical oral brain-penetrant TYK2 inhibitor.We are in search of exceptional talent who share our passion for patient care and possess a proven track record in acquiring, developing, and commercializing global products. Joining Zenas offers the opportunity to thrive in a dynamic learning environment and achieve personal and organizational success as we strive to become a leader in immunology and autoimmune disease treatment, while upholding our values of Transparency, Relationships, Urgency, Excellence, and Innovation—embracing TRUE Innovation!Position Summary:The Senior Director of Pricing and Contracting will spearhead the development and implementation of the U.S. pricing and contracting strategy to ensure optimal market access, reimbursement, and financial performance for Zenas BioPharma’s portfolio. This role includes crafting contracting strategies with national and regional payer organizations, pharmacy benefit managers (PBMs), and government payers. Reporting directly to the Vice President of U.S. Market Access, the individual will oversee pricing strategy formulation, gross-to-net modeling, and payer contracting strategies that will support both product launch initiatives and lifecycle management.

Are you eager to contribute to the future of engineering?Simpson Gumpertz & Heger (SGH) is a premier national engineering firm dedicated to providing holistic solutions for our clients' most intricate challenges. We combine our diverse expertise, technical skills, and industry knowledge in structures and building enclosures, advanced analysis, performance and code consulting, and applied science and research to create unparalleled solutions that enhance performance. With a team of 800 professionals across various offices nationwide, SGH continually strives to redefine possibilities in the engineering field.What sets careers at SGH apart?At SGH, we believe in the power of inquiry and exploration. Each team member is both a learner and an educator, devoted to personal and professional growth for themselves, their teams, and the industry as a whole. Together, we are cultivating a community that continually seeks improvement and innovation.Reasons to join SGH:Our Work: Our clients rely on us for clarity and exceptional solutions for their most challenging projects.Our People: We are innovative thinkers and supportive teammates, dedicated to lifelong learning and career advancement.Our Commitment: We act with integrity and are dedicated to contributing positively to our professions and communities.Our Benefits: We offer a generous compensation and benefits package, including both company-paid and voluntary programs to promote healthy lifestyles, strong relationships, and financial security. Work Arrangement: This role can be performed in-office or in a hybrid format, based out of our Waltham, MA office.We are seeking an individual who is passionate about delivering high-quality legal support.Join our dynamic team committed to providing outstanding legal support within one of the leading engineering firms in the country! We are looking for a detail-oriented, resourceful individual with excellent customer service skills, the ability to juggle multiple competing priorities, and a strong commitment to teamwork.Key Responsibilities:Manage and prioritize incoming requests to the Legal Department for contract reviews, insurance certificates, and other inquiries, collaborating closely with both operations and technical staff to gather required information for timely reviews and responses.Review, modify, and summarize incoming contract revisions, ensuring compliance with company standards.

About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.

As the Manager of Quality Systems and Compliance at Deciphera Pharmaceuticals, you will lead the initiatives to ensure that our quality systems comply with regulatory expectations and industry standards. You will play a crucial role in maintaining the integrity of our processes and overseeing compliance with Good Manufacturing Practice (GMP) regulations.Your leadership will be pivotal in driving continuous improvement across our quality systems, supporting our commitment to delivering high-quality pharmaceutical products. You will collaborate with cross-functional teams to implement strategies that promote compliance and enhance operational efficiency.

About the Role Zenas Bio is looking for a Director of Global Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This leader will guide the company’s quality assurance activities and maintain compliance with regulatory standards. Key Responsibilities Oversee global quality assurance processes related to GCP and GLP. Ensure all practices meet current regulatory requirements and industry standards. Location This position is based in Waltham, MA.

Deciphera Pharmaceuticals is looking for a dynamic and strategically minded Associate Director of Global Site Contracts, Budgets, and Payments to spearhead our global site contracting and investigator grant initiatives across our clinical programs. This pivotal role is essential for ensuring the timely initiation and execution of studies by providing finalized site agreements, budgets, and payment plans that are in sync with corporate and program timelines. Key Responsibilities:Act as the go-to expert and primary point of escalation for global site contracts, budgets, and payments.Lead the creation of investigator grant budgets, payment terms, and contracting strategies.Manage contract tracking, documentation, and compliance within our internal systems and with external partners.Offer oversight and support to study teams and CROs during feasibility, startup, maintenance, and closeout phases.Collaborate across functions with Clinical Operations, Legal, Compliance, Finance, and CROs to facilitate efficient study startup and lifecycle execution.Participate in bid defenses, joint operating committees (JOCs), kickoff meetings, and other program discussions.Drive department initiatives, implement process enhancements, and mentor team members.Willingness to travel up to 25% as required.

Deciphera Pharmaceuticals, Inc. is hiring a Senior Manager, Clinical Quality Assurance in Waltham. This position leads the Clinical Quality Assurance team and plays a central role in maintaining high standards for clinical trial quality and regulatory compliance. Role Overview The Senior Manager, Clinical Quality Assurance develops and implements quality assurance strategies for clinical programs. The role involves oversight of compliance with regulatory requirements and internal quality expectations throughout all phases of clinical trials. Key Responsibilities Lead the Clinical Quality Assurance team Develop and execute quality assurance strategies for clinical trials Conduct audits to assess compliance with regulatory standards Ensure all clinical trial activities meet regulatory and company quality requirements What We’re Looking For Extensive experience in clinical quality assurance Strong knowledge of regulatory requirements for clinical trials Proven ability to develop and implement quality assurance processes Experience conducting audits in a clinical setting

Role Overview Boston Engineering Corporation is hiring a Senior Electrical Engineer with a focus on embedded systems and controls. This position is based in Waltham and plays a key part in designing and developing electrical solutions for a range of projects. What You Will Do Design and develop electrical systems for embedded and control applications Work closely with engineers from multiple disciplines Contribute technical expertise to projects across different industries Team and Impact Collaborate with a skilled engineering team to deliver solutions that support innovative client projects. The work spans several industries and helps advance new developments at Boston Engineering Corporation.

We are seeking a passionate and detail-oriented Quality Assurance Analyst to join our dynamic team in Waltham. In this role, you will play a critical part in ensuring the quality and reliability of our software products through rigorous testing and analysis. You will collaborate closely with developers and project managers to identify issues and recommend solutions, contributing to our commitment to excellence.

At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.