Senior Analytical QA Specialist - Regulatory Submissions
Scorpion Therapeutics
Scorpion Therapeutics is seeking an experienced QA professional to review analytical quality documentation supporting regulatory submissions and batch dispositions. The role emphasizes GMP compliance, method validation oversight, and collaboration with CMOs and laboratories. The candidate will evaluate raw data, CoAs/CoTs, and change controls, ensuring accuracy and traceability across analytical records. Strong communication and multitasking are required. #J-18808-Ljbffr Scorpion Therapeutics
- Responsibilities Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements, annual reports). Review and... ...in analytical development, manufacturing, or QA in biotechnology (or equivalent). 3+ years experience...RegulatoryContract workFlexible hours
- ...is seeking a Sr. Associate Scientist to contribute to our Analytical Development team. The Sr. Associate Scientist will participate... ...testing laboratories. Provide support as required for regulatory submissions. Train other qualified staff to ensure effective execution...SeniorRegulatoryContract workFor contractorsLocal area
$105k - $125k
Job Summary:The Sr. Specialist, Quality Assurance is an intermediate level position with hands-on QA experience. Under moderate supervision... ..., Utilities, Equipment, Analytical Instruments, and... ...Facilities, IT, Supply Chain, and Regulatory Affairs.Location: Newark, CA...SeniorRegulatoryWork at officeLocal areaFlexible hours$150k - $160k
Sr. Scientist, Analytical Development and Quality Control... ...company is seeking a Senior Scientist, Analytical... ...across CMC, Regulatory Affairs, Quality, Manufacturing... ...submission experience would be highly... ...speak to one of our specialists please request a call...SeniorRegulatoryPermanent employment$140k - $160k
Position: Senior Scientist, Analytical Development & Quality Control Location: Newark, CAJob Id: 426... ...Substance, Drug Product, Supply Chain, Quality Assurance, Regulatory, Nonclinical, and Clinical teams to achieve program objectives...SeniorRegulatoryFull timeTemporary workWork at officeFlexible hours$36 - $48 per hour
...Job Description: The QA Specialist will provide Quality Assurance... ...for Quality Control and Analytical Laboratories. Working in a... ...records (sample plans, sample submission forms, etc.) and quality... ...systems, internal SOPs, and regulatory requirements and to resolve...RegulatoryFull timeTemporary workWork at office$125k - $135k
...sciences company, providing a unique range of analytical testing services to clients across... ...over the past 20 years.Job DescriptionThe Senior Scientist, Analytical Development is... ...scientific accuracy, data integrity, and regulatory compliance.Maintain accurate records in...SeniorRegulatoryFull timeContract workMonday to Friday- Affirm is hiring a Senior Analyst to own the end-to-end analytical lifecycle for risk and growth across products and geographies. You will translate regulatory and economic insights into actionable business strategies while collaborating with ML, engineering, product,...SeniorRegulatoryRemote job
- ...seeking a new member of the Analytical Development team to drive hands... ..., specification-setting, regulatory submissions, and long-term control strategy... ...work closely with AD, QC, QA, and regulatory partners.... ...could flex from Scientist to Senior Scientist level. Total compensation...SeniorRegulatoryFlexible hours
- ...department's project portfolio, drive cross-functional roadmaps, ensure regulatory compliance, and deliver data-driven insights to senior leadership. This role requires 10+ years of leadership in analytics and process optimization and a strong preference for insurance...SeniorRegulatory
- ...Therapeutics in Palo Alto, CA, seeks an Associate Director for Regulatory Affairs, focusing on Chemistry, Manufacturing, and Controls (... ...input, document preparation and management of regulatory submissions. Applicants with a Bachelor's degree in Chemistry or related...SeniorRegulatory
$120k - $150k
...governance, and systems remain compliant, efficient and aligned with regulatory requirements and industry standards.Review and coordinate... ...years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.Experience in developing and implementing...SeniorRegulatoryFull timeWork at officeLocal area- ...the San Francisco Bay Area seeks a scientific leader to direct analytical method development for complex large molecule therapeutics,... ...with Chemistry, Translational, Process Development, Quality, Regulatory Affairs, Manufacturing, and external CROs/CMOs to establish robust...SeniorRegulatory
$150k - $189k
...mutations in the RAS signaling pathway.The Opportunity:The Senior Manager, Compliance Monitoring & Data Analytics is responsible for planning, executing, and... ...Commercial, Medical Affairs, Clinical Development, Regulatory, Market Access, Patient Services, Finance, Human Resources...SeniorRegulatoryFull timeLocal area- Position: Sr. Director, Analytical Development and... ...functional areas and to senior leadership Support, in... ...collaboration with Quality and Regulatory, selection of... ...Work with Regulatory, QA and Senior Management... ...sections of regulatory submissions (i.e. IMPD/INDs/NDA),...SeniorRegulatoryWork at office
$179k - $210k
...high, and so are the rewards. Robinhood’s Analytics Engineering team, part of the Data... ...power everything from product innovation to regulatory compliance and operational excellence. Our... ...clear, actionable intelligence. As a Senior Analytics Engineer , you will be a key architect...SeniorRegulatoryWork at officeFlexible hoursShift work3 days per week- Position: Senior Director of Decision Analytics Location: Milpitas, CA Job Id: 229 # of Openings: 1 Job Title: Senior Director of Decision Analytics... ...monitoring, and controls that keep pace with regulatory expectations. Act as a trusted advisor to Product, Engineering...SeniorRegulatoryWork at office
$155k - $200k
...This role involves leading all QC functions, ensuring compliance with regulatory standards, and optimizing laboratory IT systems. The ideal candidate has over 6 years of experience, strong analytical skills, and a Bachelor's degree in a scientific field. The position offers...SeniorRegulatory- ...Position Summary Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory... ...clinical development through regulatory submission, approval, and product launch, with... ...managing personnel and setting goals. Strong analytical, communication, conflict management,...SeniorRegulatory
- ...Opportunity:Seeking a Senior Manager, GMP Quality who... ...for providing QA support for batch disposition... ...(CMC), Supply Chain, Analytical Development, and other... ...Support quality review of regulatory documents (IND/IMPD,... ...late-stage regulatory submissions, and commercial...SeniorRegulatory
- Eurofins USA Discovery Services is seeking a Senior Scientist, Analytical Development, to design and develop cell-based bioassays for potency and... ...collaboration, high-quality documentation, and regulatory compliance. The candidate will lead assay development, qualification...SeniorRegulatory
$140k - $160k
Specialist/Senior Specialist GMP QA - CMC Operations - Permanent - Newark CAAre you passionate about GMP quality... ...compliance, ensuring adherence to regulatory standards. This position involves... ...Records, Executed Batch Records, analytical results, and supporting data...SeniorRegulatoryPermanent employmentContract work$90k - $105k
...Quality Control Analyst II, Analytical ( Newark, CA) Revance Therapeutics, Inc. JOB DESCRIPTION... ...and review data to ensure accuracy and regulatory compliance. Support sample receiving,... ...collaboratively with Manufacturing, QA and Regulatory to support CMC analytical...RegulatoryContract workInternshipWork at officeRemote work$161k
...software validation, compendial monitoring/regulatory surveillance, QC document lifecycle... ...ICH Guidelines, and ISO certifications ~ QA experience reviewing documentation preferred ~ Advanced knowledge of analytical methods and testing using QC related instrumentation...SeniorRegulatoryFull timeFlexible hours$165k - $348k
The group you’ll be a part ofThe impact you’ll makeAs Senior Manager, Regulatory Counsel, you will play a critical role in providing strategic... ...that supports business objectives.Strong business judgment, analytical skills, and a pragmatic, solution-oriented approach to...SeniorRegulatoryContract workPrivate practiceLocal areaRemote workFlexible hours2 days per week3 days per week1 day per week- ...Pneuma, Inc. is a clinical-stage biotechnology company seeking a senior regulatory affairs leader to manage all regulatory activities and... ...requirements into practical plans and coordinate with partners for submissions. This role requires IND and NDA experience, CDER/CDRH...Regulatory
- ...Senior Vice President of Consumer Lending About the Company Large federal credit... ...lending goals, responding to changes in regulatory and market conditions, and championing continuous... ...communication, problem-solving, and analytical skills, as well as the ability to...SeniorRegulatory
$155k - $180k
...highly motivated individual to join us as a Senior Manager, External Manufacturing. This... ...which meets quality, compliance and regulatory requirementsLead cross-functional Joint... ...preferred.Experience with CMC regulatory submissions preferred.Highly developed leadership skills...SeniorRegulatoryFull timeContract workLocal area$92k - $133k
...supporting schedules. 10.Assist with the preparation and review of regulatory reports, including HCAI reports and other reimbursement... ..., and net revenue accounting preferred. 2.Strong analytical and problem-solving skills with attention to detail and accuracy...SeniorRegulatoryFlexible hours- ...including state and federal courts and regulatory agencies.Oversee internal investigations... ...closely with internal investigators, HR, and senior management.Develop employment-related... ...-energy environment.Must have strong analytical and communication skills, and demonstrated...SeniorRegulatoryPrivate practiceLocal areaRemote workFlexible hours2 days per week3 days per week1 day per week
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