Quality Control Analyst - Lexington, MA 02421( onsite) Alpha Business SolutionsQuality Control Analyst - Lexington, MA 02421( onsite)Lexington, MA$32–$36 / hourIdeal Candidate: A laboratory-focused Chemistry, Biology, or Biochemistry professional who is comfortable performing hands-on experiments while also supporting technical documentation, SOP revisions, analytical method/instrument projects, and GMP quality control activities. The role will involve working under the guidance of the Lab Manager and experienced QC staff while ensuring all activities are performed in compliance with GMP, regulatory requirements, and established quality control practices.
Manager, Quality Control Consultant The Steely GroupManager, Quality Control ConsultantHybrid, Waltham, MAThe selected candidate will work collaboratively with Analytical Quality Control leaders to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs and Quality Assurance to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. Contribute to regulatory and technical documentation by reviewing QC data for accuracy, completeness, and traceability; verifying data transcription and data checks supporting regulatory submissions; and ensuring information is ready for inclusion in internal reports, APQRs, Module 3 submission-supporting documents, and responses to regulatory authorities.
Quality Control Chemist Integrated Resources, IncQuality Control ChemistNorton, MA$25–$30 / hourThe Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization. Key Responsibilities (including but not limited to): Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies under supervision, following established SOPs.
Quality Control Inspection - DEFENSE The Structures Company, LLCQuality Control Inspection - DEFENSEChelmsford, MAAs trusted partners to major aerospace OEMs and Tier 1 suppliers, we connect professionals with opportunities to grow and excel in the aviation and aerospace industries. Perform all types of inspections to support all phases of assembly and manufacturing, including subcontracted and purchased parts.
Associate Director, Quality Control Lab Automation ModernaTXAssociate Director, Quality Control Lab AutomationNorwood, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. The Associate Director, Quality Control Lab Automation Strategy & Digital Integration is responsible for leading the strategy, implementation, and lifecycle management of laboratory automation and digital integration across Moderna’s Quality Control laboratories.
Associate Director, Quality Control (56861) Praxis Precision MedicinesAssociate Director, Quality Control (56861)Boston, MAPraxis is seeking a highly experienced, motivated, and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate Director, Quality Control to support QC product release and stability activities. Reporting to Senior Director, Quality Operations CMC, this position will be responsible for managing and executing Quality Control activities in support of product testing, release, and stability, and toxicology studies test material inventory support.
Vice President, Quality Control Candel TherapeuticsVice President, Quality ControlNeedham, MAFull timeThe Vice President, Quality Control will provide strategic, technical, and operational leadership for all Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. This role will work closely with CMC leadership, Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Development, Supply Chain, Program Management, external laboratories (CROs/CDMOs), and executive leadership.
Senior Manager/Associate Director, Quality Control Xenon PharmaceuticalsSenior Manager/Associate Director, Quality ControlNeedham, MassachusettsLead the assigned program’s stability activities, including trending, statistical evaluation, and scientific interpretation of stability data to assess product performance throughout its lifecycle, support shelf-life extensions and expiry dating justifications, and proactively identify and evaluate emerging stability risks and trends. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Analyst II, Quality Control Molecular Biology The Steely GroupAnalyst II, Quality Control Molecular BiologyWoburn, MAThe QC Analyst II will perform analytical methods including but not limited GC titer determination by ddPCR and qPCR, impurity testing, and other methods as needed to support in-process, drug substance and drug product release, stability to support AAV-based gene therapy programs. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.
Quality control manager Integrated Resources, IncQuality control managerCambridge, MassachusettsContractorExperience directing activities related to analytical method development, qualification and validation of small molecules, oral solid dosage assays, method performance monitoring, methods transfer and working with external laboratories. Manage small molecules/oral solid dosage analytical test methods validations and transfers for release and stability testing of commercial pharmaceutical products.
Quality Control Analyst Integrated Resources, IncQuality Control AnalystLexington, MassachusettsContractorA Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Quality Control Analyst III Integrated Resources, IncQuality Control Analyst IIILexington, MassachusettsContractorTesting may include but not limited to samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendial and non-compendial sources. Experience Required: Specific QC Focus Areas: Product Testing: Area focuses on techniques such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays.
Quality Control Technician ManpowerQuality Control TechnicianFranklin, MAp> ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
Quality Control / Documentation Analyst Karwell TechnologiesQuality Control / Documentation AnalystLexington, MAJob 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.
Senior Director, Analytical Development & Quality Control Rhythm PharmaceuticalsSenior Director, Analytical Development & Quality ControlBoston, MA$210,000–$300,000 / yearYou will lead and develop a high-performing organization while overseeing external partners, including CDMOs, CROs, and contract laboratories, to deliver analytical development and QC activities across drug substance and drug product. As the Senior Director, Analytical Development and Quality Control, you will provide strategic and technical leadership for analytical development and quality control across Rhythm's portfolio, spanning discovery through commercialization and lifecycle management.
Training Instructor /Quality Control Monitor - AIS AhtnaTraining Instructor /Quality Control Monitor - AISAndover, MassachusettsOutlines comprehensive documentation, QC measures, inspection programs, internal audits, personnel training, and master file of QC inspections (includes inspections scheduled and performed, results of completed inspections, and dates/details of any corrective actions taken). Complete and/or maintain an approved and accredited Principles of Instruction course or similar training (NRA, Police Academy, state POST Academy, FLETC, or military training course) certifying the individual as an instructor showing competency in the performance areas of: Presentation skills.
Scientist I, Analytical Development and Quality Control Kailera TherapeuticsScientist I, Analytical Development and Quality ControlWaltham, Massachusetts$106,000–$130,000 / yearThe Scientist I, Analytical Development and Quality Control is an experienced scientist within the Analytical Development and Quality Control (AD/QC) organization, with a primary focus on analytical quality control, method validations, stability programs, and data integrity. Evaluate temperature excursions for stability and release samples, assessing potential impact on product quality using scientific judgment, stability data, and relevant regulatory/technical guidance.
Senior Manager, Quality Control Stoke Therapeutics, Inc.Senior Manager, Quality ControlBedford, MA$172,000–$192,000 / yearManager, Quality Control (QC) is responsible for overseeing all aspects of GMP testing and supporting stability program management for Stoke' IMPs at Stoke's Contract Testing Laboratories (CTLs) / Contract Manufacturing Organizations (CMOs). Oversee day-to-day management of outsourced GMP release testing at various CTLs / CMOs to ensure successful and compliant execution of laboratory operations to meet GMPs, regulatory requirements, guidelines, internal policies, and procedures.
Senior Manager, Analytical Development & Quality Control Alpha-9 Oncology, Inc.Senior Manager, Analytical Development & Quality ControlBoston, MA$175,000–$194,000 / yearAlpha-9 Oncology is seeking a highly motivated Senior Manager, Analytical Development & Quality Control, to provide technical and operational leadership for quality control and analytical lifecycle activities across clinical-stage radiopharmaceutical programs. This role will serve as a primary analytical and QC representative supporting development programs through data trending, statistical analysis, batch release support, investigation management, CDMO oversight, analytical readiness activities, and clinical supply support.
Data Integrity Program Manager - Quality Control Rentschler BiopharmaData Integrity Program Manager - Quality ControlMilford, MassachusettsThe QC Data Integrity Program Manager, will be responsible for ensuring compliance and alignment to all relevant regulatory and internal requirements related to data integrity as well as developing training material and leading training efforts with Quality Control Staff. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.