Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Analytical QA Specialist - Regulatory Submissions in Newark, CA vacancy
  • 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... 
    Regulatory
    Contract work
    Flexible hours

    Scorpion Therapeutics

    Newark, CA
    1 day ago
  •  ...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... 
    Senior
    Regulatory
    Contract work
    For contractors
    Local area

    Revance

    Newark, CA
    3 days ago
  • $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... 
    Senior
    Regulatory
    Work at office
    Local area
    Flexible hours

    Revance

    Newark, CA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Permanent employment

    ProClinical

    Newark, CA
    2 days ago
  • $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... 
    Senior
    Regulatory
    Full time
    Temporary work
    Work at office
    Flexible hours

    Protagonist Therapeutics

    Newark, CA
    2 days ago
  • $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... 
    Regulatory
    Full time
    Temporary work
    Work at office

    Asahi Kasei

    Fremont, CA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Full time
    Contract work
    Monday to Friday

    Eurofins

    Fremont, CA
    1 day ago
  • 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,... 
    Senior
    Regulatory
    Remote job

    Affirm

    Palo Alto, CA
    1 day ago
  •  ...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... 
    Senior
    Regulatory
    Flexible hours

    Retro

    Redwood City, CA
    3 days ago
  •  ...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... 
    Senior
    Regulatory

    Jobtailor

    Palo Alto, CA
    20 hours ago
  •  ...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... 
    Senior
    Regulatory

    Summit Therapeutics

    Palo Alto, CA
    2 days ago
  • $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... 
    Senior
    Regulatory
    Full time
    Work at office
    Local area

    Revolution Medicines

    Redwood City, CA
    4 days ago
  •  ...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... 
    Senior
    Regulatory

    Valid8 Financial, Inc.

    Redwood City, CA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Full time
    Local area

    Revolution Medicines

    Redwood City, CA
    20 hours ago
  • 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),... 
    Senior
    Regulatory
    Work at office

    Allakos

    Redwood City, CA
    4 days ago
  • $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... 
    Senior
    Regulatory
    Work at office
    Flexible hours
    Shift work
    3 days per week

    Unchain Data

    Menlo Park, CA
    2 days ago
  • 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... 
    Senior
    Regulatory
    Work at office

    Payactiv

    Milpitas, CA
    1 day ago
  • $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... 
    Senior
    Regulatory

    Bionova Scientific, Inc.

    Fremont, CA
    1 day ago
  •  ...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,... 
    Senior
    Regulatory

    Scorpion Therapeutics

    Redwood City, CA
    6 hours ago
  •  ...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... 
    Senior
    Regulatory

    Planet Pharma

    Redwood City, CA
    2 days ago
  • 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... 
    Senior
    Regulatory

    Eurofins DiscoverX

    Fremont, CA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Permanent employment
    Contract work

    ProClinical

    Newark, CA
    3 days ago
  • $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... 
    Regulatory
    Contract work
    Internship
    Work at office
    Remote work

    Revance

    Newark, CA
    4 days ago
  • $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... 
    Senior
    Regulatory
    Full time
    Flexible hours

    Nova Pneuma, Inc.

    Fremont, CA
    5 days ago
  • $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... 
    Senior
    Regulatory
    Contract work
    Private practice
    Local area
    Remote work
    Flexible hours
    2 days per week
    3 days per week
    1 day per week

    Lam Research Corporation

    Fremont, CA
    1 day ago
  •  ...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

    Nova Pneuma, Inc.

    Fremont, CA
    2 days ago
  •  ...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... 
    Senior
    Regulatory

    Confidential

    Fremont, CA
    3 days ago
  • $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... 
    Senior
    Regulatory
    Full time
    Contract work
    Local area

    Allogene Therapeutics

    Newark, CA
    3 days ago
  • $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... 
    Senior
    Regulatory
    Flexible hours

    Washington Hospital

    Fremont, CA
    4 days ago
  •  ...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... 
    Senior
    Regulatory
    Private practice
    Local area
    Remote work
    Flexible hours
    2 days per week
    3 days per week
    1 day per week

    Lam Research Corporation

    Fremont, CA
    16 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Analytical QA Specialist - Regulatory Submissions. Be the first to apply!