• Serve as the GMP QA partner for the development programs, from early phase through validation • Review and approve analytical method transfer and validation protocols and final reports for Drug Substance and Drug Product • Review and approve analytical methods and specifications, stability protocols and reports • Perform review and approval of analytical and microbiological testing data for Drug Substance, Drug Product Intermediates and Drug Product • Perform batch record review and disposition related activities for Clinical and Commercial Supplies • Review and approve Master Batch Records, review CMO change controls and provide quality impact assessments relating to proposed changes • Coordinate Quality Events (Laboratory Investigations, Deviations, CAPAs) with CMOs and escalate to QA management as appropriate • Oversee QA aspects of API, Drug Product and Packaging and Labeling Operations for Crinetics products • Represent QA in internal and external team meetings • Support QA team on internal and external GMP audits • Perform and/or review impact assessments and risk assessments • Write and review Standard Operating Procedures • Write internal investigations, as applicable; review external, CMO investigations as assigned • Compile metrics of Batch Disposition, deviations, CAPAs, as applicable • Perform vendor audits as assigned and support vendor lifecycle activities

Role Description Lead quality assurance initiatives across our Node.js, TypeScript, and React applications, ensuring robust testing strategies and high-quality deliverables. - Collaborate closely with Product Managers to define acceptance criteria, validate requirements, and establish quality gates throughout the development lifecycle. - Develop and maintain test management processes, creating detailed test cases, test suites, and comprehensive test documentation. - Create and maintain testing playbooks that standardize quality processes across engineering teams and ensure consistent testing approaches. - Build and manage a centralized test index to organize, categorize, and maintain visibility of all test assets across projects and features. - Establish quality metrics and reporting to provide visibility into test coverage, defect trends, and overall product quality health. - Drive continuous improvement of testing processes, tools, and methodologies to enhance efficiency and effectiveness. - Coordinate testing efforts across multiple teams and projects, ensuring quality standards are maintained during rapid development cycles. - Lead defect triage and resolution processes, working with development teams to prioritize and address quality issues effectively. Qualifications - 3+ years of experience in software quality engineering with a strong focus on manual testing and quality processes. - Strong experience with test management platforms for test case management, execution tracking, and reporting. - Demonstrated expertise in collaborating with Product Managers to translate business requirements into testable acceptance criteria. - Strong background in creating and maintaining testing playbooks, documentation, and standardized quality processes. - Experience building and managing test indexes to organize and maintain comprehensive test asset libraries. - Understanding of API testing for RESTful and WebSocket APIs, including tools like Postman, Newman, or similar. - Familiarity with cloud testing environments (preferably AWS) and containerized testing approaches. - Strong analytical and problem-solving skills with attention to detail and systematic approach to quality assurance. - Excellent communication skills for collaborating with cross-functional teams and presenting quality metrics to stakeholders. - Experience with agile methodologies and working in fast-paced, iterative development environments. - Knowledge of accessibility testing and web standards compliance. Benefits - The opportunity to join a goal-driven startup with big ambitions. - An open, inclusive working environment, with founders deeply-rooted in the startup space. - An agile working model focused on goals and performance. - International environment with diverse culture. - Competitive remuneration package. - Remote-first and flexible working arrangements. - Flexible medical benefits scheme. Equal Opportunity Statement At OSOME, creating a culture where individuals of all backgrounds feel comfortable really matters. Everyone who applies will receive fair consideration for employment. We do not discriminate based upon race, colour, religion, sex, sexual orientation, age, marital status, gender identity, national origin, disability, or any other applicable legally protected characteristics in the location in which the candidate is applying. We want to ensure that we represent the diversity of talent in the society we live in today. If you have any accessibility requirements that would make you more comfortable during the application and interview process, please let us know so that we can support you.

Northeast Family Services is looking for a professional Excel guru with exceptional administrative, reporting, and data analytics skills to join our growing team as Clinical Data and Quality Coordinator. As an important member of the operations and quality assurance team, the Clinical Data and Quality Coordinator, in partnership with the QA Manager, will be the in-house expert for all EHR (Electronic Health Record) related projects. Managing and tracking daily productivity reports is a key function of this role, as well as establishing KPIs, QA Plans, data utilization, monitoring, and reporting on compliance. If you're looking to make a change and put your administrative, reporting, and data analytics skills to use, don’t miss this opportunity to take your career to the next level and join a growing, well-regarded organization that truly cares for their employees and clients! This is a remote position, but must reside in RI, MA, NH, or NY. Responsibilities: - Collaborate with QA Manager to review, quality check, and clean data sets - Provide a high level of attention to detail and consultative service skills with interactions of staff - Participate in development of training plans for data utilization - Acts as project coordinator for all Clinical Quality related projects such as establishing KPIs, Quality Assurance Plans, monitoring, and reporting on compliance - Responsibility for problem solving, assessing processes and issues, and collaborating with staff and providers to develop solutions resulting in efficient and functional workflows for end users of our software application. - Identifies, assesses, troubleshoots EHR related issues as they occur, and sees through to full resolution. - Coordinate documentation and training. - Maintains proper user control by adding and deactivating users and updating credentials as necessary - Maintains confidentiality of all patient/client and employee information - Collaborates with Program Directors to disseminate and review data as required - Participates in agency meetings and in-services. Completes staff training as required - Other duties as assigned Qualifications: - High School Diploma or equivalent - Minimum 2 years of experience with data analytics - Minimum 2 years of (EHR) Electronic Health Records technical support, training, and administration experience preferred - Experience in supporting behavioral health programming - Extensive knowledge of and experience with various computer programs including Word, Excel, and Outlook. - SQL experience is a plus! - Excellent communication skills - Ability to formulate positive collaborative relationships with the program managers and staff - Ability to work remotely and must reside in RI, MA, NH, or NY. Benefits: - Health, Dental & Vision - 3 weeks paid vacation - 11 Paid holidays (including Juneteenth, the day after Thanksgiving, Christmas Eve, and NY Eve.) - Generous sick time including mental health days - 401k retirement plan with up to 4% match - Voluntary short and long-term disability - Voluntary Life Insurance - Dependent care savings account - Mileage reimbursement - Longevity award - Monetary bonus and a vacation day annually - Company provided laptop and cell phone - Opportunity for professional growth - Supervision for licensure provided - Tuition Reimbursement - Personal cell phone discount Hours / Compensation: - Full Time - Salary $50,000 - $60,000

Northeast Family Services is looking for a professional Excel guru with exceptional administrative, reporting, and data analytics skills to join our growing team as Clinical Data and Quality Coordinator. As an important member of the operations and quality assurance team, the Clinical Data and Quality Coordinator, in partnership with the QA Manager, will be the in-house expert for all EHR (Electronic Health Record) related projects. Managing and tracking daily productivity reports is a key function of this role, as well as establishing KPIs, QA Plans, data utilization, monitoring, and reporting on compliance. If you're looking to make a change and put your administrative, reporting, and data analytics skills to use, don’t miss this opportunity to take your career to the next level and join a growing, well-regarded organization that truly cares for their employees and clients! This is a remote position, but must reside in RI, MA, NH, or NY. Responsibilities: - Collaborate with QA Manager to review, quality check, and clean data sets - Provide a high level of attention to detail and consultative service skills with interactions of staff - Participate in development of training plans for data utilization - Acts as project coordinator for all Clinical Quality related projects such as establishing KPIs, Quality Assurance Plans, monitoring, and reporting on compliance - Responsibility for problem solving, assessing processes and issues, and collaborating with staff and providers to develop solutions resulting in efficient and functional workflows for end users of our software application. - Identifies, assesses, troubleshoots EHR related issues as they occur, and sees through to full resolution. - Coordinate documentation and training. - Maintains proper user control by adding and deactivating users and updating credentials as necessary - Maintains confidentiality of all patient/client and employee information - Collaborates with Program Directors to disseminate and review data as required - Participates in agency meetings and in-services. Completes staff training as required - Other duties as assigned Qualifications: - High School Diploma or equivalent - Minimum 2 years of experience with data analytics - Minimum 2 years of (EHR) Electronic Health Records technical support, training, and administration experience preferred - Experience in supporting behavioral health programming - Extensive knowledge of and experience with various computer programs including Word, Excel, and Outlook. - SQL experience is a plus! - Excellent communication skills - Ability to formulate positive collaborative relationships with the program managers and staff - Ability to work remotely and must reside in RI, MA, NH, or NY. Benefits: - Health, Dental & Vision - 3 weeks paid vacation - 11 Paid holidays (including Juneteenth, the day after Thanksgiving, Christmas Eve, and NY Eve.) - Generous sick time including mental health days - 401k retirement plan with up to 4% match - Voluntary short and long-term disability - Voluntary Life Insurance - Dependent care savings account - Mileage reimbursement - Longevity award - Monetary bonus and a vacation day annually - Company provided laptop and cell phone - Opportunity for professional growth - Supervision for licensure provided - Tuition Reimbursement - Personal cell phone discount Hours / Compensation: - Full Time - Salary $50,000 - $60,000