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...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
- Proclinical Staffing seeks a Sr. Scientist, Analytical Development & Quality Control in the East Bay Area to provide analytical leadership... ...control throughout the product lifecycle, working across CMC, Regulatory, Quality and Manufacturing in a fast-moving biotech setting....SeniorRegulatory
$105k - $125k
Revance is seeking a Sr. Specialist, Quality Assurance in Newark, CA for hands-on QA within Quality Systems, focusing on lifecycle management of GxP facilities... ...Control, Manufacturing, IT, Supply Chain, and Regulatory Affairs. The role offers a hybrid schedule (3 days...SeniorRegulatoryWork at office- ...Techne is seeking a Sr. Quality Assurance Specialist to ensure quality processes are... ..., internal audits, CAPA activities, and regulatory reporting while supporting batch record... ...environment. The role requires 3+ years in QA, strong communication, and experience with...SeniorRegulatory
$150k - $160k
Sr. Scientist, Analytical Development and Quality Control - Permanent... ..., the company is seeking a Senior Scientist, Analytical... ...significant visibility across CMC, Regulatory Affairs, Quality,... ...regulatory expectations Regulatory submission experience would be highly advantageous...SeniorRegulatoryPermanent employment$36 - $48 per hour
## QA Specialist - Full Time & TemporaryApplyremote type: On-sitelocations... ...for Quality Control and Analytical Laboratories. Working in a... ...(sample plans, sample submission forms, etc.) and quality control... ..., internal SOPs, and regulatory requirements and to resolve...RegulatoryFull timeTemporary workWork at office$140k - $160k
Position: Senior Scientist, Analytical Development & Quality Control Location: Newark, CAJob Id: 426... ...Johnson assuming responsibility for further clinical and regulatory development and commercialization. Protagonist also discovered...SeniorRegulatoryFull timeTemporary workWork at officeWorldwideFlexible hoursProtagonist Therapeutics
Newark, CA6 days ago- Revolution Medicines is seeking a Senior Associate Regulatory Affairs to support management in day-to-day operations and to help coordinate submissions to global health authorities. The base pay ranges reflect onsite responsibilities at our Redwood City, CA headquarters...SeniorRegulatory
- ...Senior Principal Architect If you are excited about shaping the future of technology... ...Corporate Technology – Corporate Data & Analytics Services (CDAS), you are an integral part... ..., data risk management policy, regulatory obligations, and security and resiliency...SeniorRegulatory
Chase
Palo Alto, CA4 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...SeniorRegulatory
$120k - $150k
...Company: Bionova Scientific LLC Job Description: This Sr. QA Specialist, Supplier Quality is part of the Quality Assurance Compliance... ...program for Bionova Scientific Preparing for and supporting regulatory agency audits, client audits and self-inspection Working Conditions...SeniorRegulatoryWork at office3 days per week$89.3k - $146.9k
...improvement are being met. The Quality Assurance Specialist recommends revisions to, or creation of,... ....Prepare quality records and for regulatory inspections.Assist with batch record... ...validationsWrite, review and/or revise QA SOPsOther quality related duties as required...SeniorRegulatoryTemporary workWork experience placementInternshipWork at officeWorldwideFlexible hours$150k - $189k
...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- Scorpion Therapeutics is seeking a Senior Quality Operations Manager to... ...ensures cGMP compliance, leads QA for CMOs, and supports tech transfers and analytical activities. You will manage deviations... ...continuous improvement and regulatory readiness. Hybrid work in Newark...SeniorRegulatory
- Ardelyx is seeking a Senior Quality Operations Manager to provide day-to-day quality oversight... ...standards, quality agreements, and regulatory requirements. You will partner with... ...Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory...SeniorRegulatoryContract work
- 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
- Bio-Techne is seeking a Quality Assurance Specialist to ensure that quality requirements are... ...requirements. Strong communication, analytical, and organizational skills are required,... ...engineering field and at least 3 years in QA. #J-18808-Ljbffr Advanced Cell Diagnostics...Senior
- Matlen Silver is looking for a detail-oriented Senior Technician - Regulatory Sciences in Fremont, CA. This on-site role involves analytical testing, documentation, and research in a regulated laboratory environment. Candidates should have a Bachelor's degree in a scientific...SeniorRegulatoryContract work
- Role: Senior Quality Operations Manager overseeing external manufacturing... ...technology transfers and analytical activities. Responsibilities: provide daily QA oversight of CMOs, suppliers, and... ...pharma/biotech experience with CMOs, regulatory compliance, and quality systems...SeniorRegulatory2 days per week3 days per week
$121.9k - $167.64k
...Motors is seeking a seasoned Senior level Global Supply Chain... ...manufacturing, management, and data analytics.The Senior Global Supply... ...-depth insights into global regulatory environments and their... ...job applications or resume submissions. To be considered for employment...SeniorRegulatoryHourly payLucid Motors
Newark, CA13 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...SeniorRegulatoryFull timeFlexible hoursNova Pneuma, Inc.
Fremont, CA25 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...SeniorRegulatoryFlexible hoursWashington Hospital
Fremont, CA4 days ago- Bionova Scientific LLC is seeking a QA Compliance professional to support GMP quality assurance, supplier qualification, and internal... ..., change control, discrepancy handling, and preparing for regulatory inspections. Requires strong communication, 5+ years in GMP QA,...Regulatory
- ...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
$165k - $175k
...Research Administration, the Senior Space Analyst is responsible... ...cost (IDC) proposal submissions to the federal government. This... ...effectively communicate and defend analytical findings to inform... ...encompasses diverse financial and regulatory complexities. Critical competencies...SeniorRegulatoryHourly payWork at office- Protagonist Therapeutics is seeking a Specialist/Sr. Specialist, Quality Assurance to perform GMP QA activities supporting manufacturing. The role reports to the Head of QA and prioritizes QA GMP support with a risk-based approach, including batch record and deviation...SeniorWork at office
$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$84k - $149k
...Senior Software Engineer At Wells Fargo, we are looking for talented people who will... ...technologies ~3+ years of reporting experience, analytics experience or a combination of both ~3... ...Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively...SeniorRegulatoryWork experience placementRemote workRelocation packagePhenom People
Fremont, CA1 day ago- Work Flexibility: Hybrid or OnsiteStryker is hiring a Senior Staff Clinical Quality Associate for our Neurovascular division. This is... ...you will focus on clinical quality, compliance governance, and regulatory readiness across global clinical research activities. You will...SeniorRegulatoryFull timeFor contractors
Stryker
Fremont, CA1 day 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!
Related searches
- senior consulting engineer Newark, CA
- senior qa Newark, CA
- senior medical science liaison Newark, CA
- senior software engineer remote Newark, CA
- senior performance engineer Newark, CA
- senior manager m&a tax Newark, CA
- senior helpdesk technician Newark, CA
- senior performance tester Newark, CA
- senior international accountant Newark, CA
- senior manager creative operations Newark, CA