Document Control Specialist, Quality The Steely GroupDocument Control Specialist, QualityBedford, MAThis role will work closely with members of the Document Control team and support routine daily operations for Document Management. This position will primarily be responsible for the processing and maintaining of GxP documents throughout their lifecycle with a focus on issuance and reconciliation.
Data Review Specialist, Quality Control Ocular TherapeutixData Review Specialist, Quality ControlBedford, MA$98,000–$113,000 / yearPosition Summary: The Data Review Specialist will apply strong technical knowledge of laboratory operations, analytical data review, data integrity requirements, and quality systems to perform thorough reviews of analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations. In addition to data review, this role will support QC data monitoring activities, including evaluation of release data, raw material testing data, and stability data trends to identify emerging patterns, atypical results, potential OOT signals, and opportunities for improved product understanding.
Quality Control Analyst (Contract) 651 Vertex PharmaceuticalsQuality Control Analyst (Contract) 651Boston, Massachusetts$36–$38 / 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: Within our Analytical Service team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
NewQuality Control Analyst Actalent IncQuality Control AnalystCambridge, MA$35–$40 / hourThe Quality Control (QC) department is essential for ensuring compliance with cGMP operations through the inspection of components and raw materials, as well as quality testing of intermediate, stability, and final product samples. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
NewDirector, Quality Control Contractor Centessa Pharmaceuticals PlcDirector, Quality Control ContractorBoston, MA$95–$120 / hourThe Director, Quality Control (contractor) will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development. Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package.
Quality Control Technician Amrize LtdQuality Control TechnicianMASubject to applicable law, employees that are required to wear respirators must be clean shaven where the respirator seal meets the face in order to pass the qualitative and quantitative fit tests. Additional Requirements: Successful candidates must adhere to all safety protocols and proper use of Amrize approved Personal Protection Equipment ("PPE"), including but not limited to respirators.
Associate Director, Analytical Development & Quality Control Alpha-9 Oncology IncAssociate Director, Analytical Development & Quality ControlBoston, MAThe successful candidate will manage relationships with external manufacturing and testing partners while partnering closely with Quality, Regulatory, Technical Operations, and Program Leadership teams to support API development, CMC activities, and timely execution of clinical supply strategies. Alpha-9 Oncology is seeking a highly experienced and motivated Associate Director, Analytical Development & Quality Control, to provide technical and operational leadership for QC activities supporting our clinical-stage radiopharmaceutical programs.
Quality Control Analyst I, Raw Materials Ocular TherapeutixQuality Control Analyst I, Raw MaterialsBedford, MA$68,000–$75,000 / yearOcular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX. Key Responsibilities: The primary responsibilities of this role will be performing qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
Quality Control Analyst LancesoftQuality Control AnalystLexington, MA$34Job Description Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team. This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
Director, Quality Control Dyne TherapeuticsDirector, Quality ControlWaltham, MA$190,000–$230,000 / yearThe Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and commercial stages. Regulatory, Inspection Readiness & Cross-Functional Collaboration Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities.
Document Control Manager - Quality, Compliance, and Oversight Massachusetts Bay Transportation AuthorityDocument Control Manager - Quality, Compliance, and OversightBoston, MAHave a satisfactory work record for the two (2) years immediately prior to the closing date of this posting (unless if current student or recent graduate), including overall employment, job performance, discipline, and safety records (infractions and/or offenses occurring after the closing of the posting and before the filling of a vacancy may preclude a candidate from consideration for selection). Bachelor's degree from an accredited institution in Business Administration, Engineering, Information Technology, Computer Science or a related field with 5 or more years of professional experience in business administration, library management, document management, information technology, training management or related field.
Scientist I, Quality Control ReplimuneScientist I, Quality ControlFramingham, MassachusettsThe 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. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs).
NewSenior Quality Control Analyst Actalent IncSenior Quality Control AnalystNorwood, MA$34–$39 / hourThe ideal candidate will have experience in molecular biology techniques, mammalian cell culture, potency assays, and QC testing within a pharmaceutical, biotechnology, or life sciences setting. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Sr. Quality Specialist, Gxp Document Control Bicara Therapeutics IncSr. Quality Specialist, Gxp Document ControlBoston, MAFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Director, Quality Control Editas MedicineDirector, Quality ControlCambridge, MA$215,000–$235,000 / yearThe successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance, to transfer, qualify and oversee in-process and release testing to advance Editas’ in vivo gene medicine portfolio. The Quality team is seeking a highly motivated and experienced technical and organizational leader in gRNA, mRNA, and Lipid Nanoparticle (LNP) analytical methodologies and GMP testing.
NewSenior Director, Biologics Analytical Development and Quality Control Korsana BiosciencesSenior Director, Biologics Analytical Development and Quality ControlBoston, MassachusettsThis leader will oversee the planning and execution of outsourced analytical development and testing activities and will work proactively with external suppliers including CDMOs and contract labs to define project scope, mitigate risks, and ensure successful delivery in relation to technical quality, timelines and budget. Collaborates with internal stakeholders in the areas of Drug Substance Development, Drug Product Development, Combination Product Development, Clinical Supply Chain, Program Management, Preclinical Development, Clinical Development/Operations, Quality, Regulatory Affairs, and external business partners to push project forward.
NewScientist I, Quality Control Replimune Group IncScientist I, Quality ControlFramingham, MAThe 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. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs).
Sr. Quality Specialist, GxP Document Control Bicara TherapeuticsSr. Quality Specialist, GxP Document ControlBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Quality Control Tech: CRH AmericasQuality Control Tech:Manchester, NHCRH is the leading vertically integrated supplier of asphalt, aggregates, cement, ready-mix concrete, and paving and construction services in North America. CRH operates in a decentralized, diversified structure that allows you to work in a small company environment while having the career opportunities of a large international organization.
Sr. Quality Control Analyst Pace Analytical ServicesSr. Quality Control AnalystWaltham, MassachusettsDesign and develop robust, scalable formulations for small molecules and biologics in early-stage clinical trials; optimize manufacturing processes for drug products. Analyze and interpret complex chemistry, biochemistry, and formulation data to identify trends and provide actionable insights to management and/or clients.