IVD GMP Documentation Scientist - Manufacturing & Compliance
DELFI Diagnostics, Inc.
DELFI Diagnostics, Inc. is seeking an experienced scientist specialized in GMP reagent manufacturing documentation under ISO 13485 and FDA PMA readiness. You will craft procedures, batch records, CoAs, study plans, and DHF content while coordinating with assay development, regulatory, and quality teams. Responsibilities include drafting and maintaining manufacturing processes, QA documentation, and regulatory submission support, with collaboration across GMP operations and supplier oversight. #J-18808-Ljbffr DELFI Diagnostics, Inc.
- DELFI Diagnostics is seeking an experienced scientist to own GMP manufacturing documentation for high-risk IVD devices. You will craft batch records, CoAs, and SOPs, and maintain DHF/DMR content for PMA submissions. Collaboration with assay development, regulatory, and...SuggestedWork at office
$62 - $80 per hour
...offices We are seeking an experienced scientist who is a subject-matter expert in GMP reagent manufacturing under ISO 13485 and IVD medical device documentation. This role will be the key... ...CoAs, deviation reports) for GMP compliance prior to lot release Support incoming...SuggestedContract workWork at office- ...Diagnostics, Inc. is seeking an experienced scientist to own GMP reagent manufacturing documentation under ISO 13485 for high-risk IVD devices. You will craft procedures,... ...CoAs and study plans, ensuring regulatory compliance and fitness for PMA submissions. Hybrid workdays...Suggested
$120k - $140k
...dedicated to the development and manufacture of best‑in‑class diagnostic... ...you an innovative, hands‑on scientist with a passion for research... ...manufacturing from bench‑scale to GMP full‑scale manufacturing. Use... ...solve technical problems. Document ongoing experiments and test...SuggestedCasual workWork at officeLocal area- AccuraGen seeks a Scientist for Reagent Manufacturing & QC to drive production, characterization, and release testing of enzymes and critical reagents... ...-on manufacturing, analytical testing, and rigorous documentation to meet design control, traceability, and regulatory...Suggested
- ...Job Description The Scientist, Reagent Manufacturing & Quality Control (... ...in vitro diagnostic (IVD) products. This role... ..., and rigorous documentation practices to support... ...traceability, and regulatory compliance. The scientist will... ...Practices (GMP) and controlled documentation...
- Eyconis, Inc. in Redwood City, CA is seeking a Scientist/Sr. Scientist in protein chemistry to drive bioconjugation discovery and... ...bioconjugation work, perform downstream purification, and support GMP manufacturing at partner CMOs. You will collaborate with Analytical...
$25 - $29 per hour
...requirements, and company procedures Ability to perform and document lithologic logging of wells and boreholes accurately during... ...environmental regulations and ability to conduct site work in compliance with applicable requirements Technical data and mapping skills...Hourly payFull timeTemporary workFor subcontractorLive inWork at office$160k - $175k
The Sr. Scientist in Quality Control will be leading analytical... ...of the QC laboratory in a GMP manufacturing facility. This is an on-site... ...quality mindset with a focus on compliance and execution Adaptability... .... Support QC systems, documentation, laboratory practices, and...Full timeTemporary workWork experience placementSummer holidayFlexible hours$124k - $171k
...and service cutting-edge equipment that helps our customers manufacture display and semiconductor chips - the brains of devices we use... ...issues. You'll also measure film properties, generate technical documentation, and engage with customers to resolve concerns. Process...Full time$146k - $171k
...making.Summary:Vaxcyte is seeking a talented and experienced Scientist II, to join the Upstream Process Development group within the... ...project meetings. Participate in upstream database management and documentation in electronic notebooks.Collaborate with Downstream Process...$116.8k - $146k
...with a non-invasive test.We are looking for a highly motivated Scientist with a strong focus on process optimization and product verification... ...will be working with internal cross functional teams to develop IVD products. The ideal candidate is a driven professional who...Immediate startWorldwide$185k - $215k
...assistance systems (ADAS), robotics, smart manufacturing, enterprise AI, health care, smart home... ....Job DescriptionAs a Senior Research Scientist- Robotics AI, you contribute to... ...conferences, workshops, and technical events.Document and disseminate research findings through...Work experience placementLocal areaWorldwide$185k - $215k
...assistance systems (ADAS), robotics, smart manufacturing, enterprise AI, health care, smart home... ....Job DescriptionAs a Senior Research Scientist- Vision-Language-Action (VLA) Models,... ...conferences, workshops, and technical events.Document and disseminate research findings...Work experience placementLocal areaWorldwide$97.4k - $168k
Scientist, Biochemistry I or IIPacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical... ...and production environment in compliance with quality standardsConduct...Full time$136.3k - $231.7k
...diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic... ...teams of physicists, engineers, data scientists and problem-solvers work together with... ...system performanceContribute to documentation, technical reviews, and design discussionsDevelop...Minimum wageFull timeWork at officeFlexible hours$113.1k - $145k
...highly motivated and hands‑on Scientist to join the Drug Product... ...technical support for outsourced GMP manufacturing activities.... ...manufacturing activities including document review. Maintain accurate... ...continuous process improvement and compliance. Actively contribute to a...Full timeLocal areaShift work$115k - $140k
...who will help us ramp toward manufacturing readiness. In the near term,... ...related activities in support of GMP readiness and production.... ...and contribute to supporting documents. Perform regular lab organization... ...from Senior RA or Associate Scientist. Total compensation also...Flexible hours$112k - $168k
## Scientist II, Field Applications Bioinformatics SupportApplylocations: US - California - Menlo Parktime type: Full timeposted on:... ...life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical...Work at officeHome office- .... The Process R&D organization is seeking a highly motivated scientist or engineer to support the development, scale-up, and commercialization... ...groups. This role will work at the interface of research, manufacturing, engineering, quality, regulatory, and commercial teams to...Full time
- Guardant Health is looking for a Clinical Development Scientist in Palo Alto, CA, to develop and execute clinical validation strategies for... ...ideal candidate will have a PhD and significant experience in IVD product development, particularly in oncology. Strong communication...
- ...Alto, CA, is seeking a Clinical Development Scientist to design and lead clinical validation studies for oncology IVD products, supporting regulatory submissions to... ...evidence strategies, ensure regulatory‑grade documentation, and participate in product development, #J-...
- Array Labs is seeking a 3D Reconstruction Scientist to develop algorithms that reconstruct 3D structures from radar and optical sensors... ...via thorough testing. This position offers competitive pay with flexible compensation options. #J-18808-Ljbffr Dormont Manufacturing CoFlexible hours
$89k - $105k
...Expectations are high, and so are the rewards. The Tax Operations team’s mission is to support our tax information reporting and compliance efforts related to the purchase and sale of equities and crypto. We collaborate closely with internal partners to ensure robust processes...Work experience placementWork at officeFlexible hoursShift work3 days per week$138.4k - $190.3k
....About the RoleThe Clinical Development Scientist will support the design, execution, and... ...clinical development strategies for oncology IVD products, including clinical validation... ...generation, and regulatory-grade documentation.Ability to work effectively in cross-functional...Full timeWork at officeWork from home- ...Engineering Physics team. You will lead dosimetry and radiation-physics analyses to ensure beam performance, safety, and regulatory compliance, and collaborate across engineering and regulatory partners. The role requires a PhD in a related field and 2+ years in radiation...
$30 - $40 per hour
...known for developing innovative laboratory, analytical, and manufacturing solutions in Sunnyvale, CA . Location: Sunnyvale, CA Work Arrangement... ...also support batch record generation and review, technical documentation, deviation investigations, in-process testing, and...Hourly payWeekly payContract workTemporary workLocal areaMonday to Friday$95.64k - $147.56k
...construction activities tied to regulatory permit compliance, and support environmental permitting,... ...Practices (BMP) implementation and documenting compliance with regulatory permit... ...medium-size projects or assist more‑senior scientists on larger projects. Conduct biological...Full timeTemporary workWork at officeLocal areaNight shift- ...products.• Plan, organize, perform, and document complex scientific experiments requiring... ...SOPs.• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC, and company Guidelines... ...improvement of existing Quality, Compliance and Safety processes and systems.• Contribute...Immediate start
$186.2k - $316.5k
...global leader in diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic device in the world is... ...into R&D. Our expert teams of physicists, engineers, data scientists and problem-solvers work together with the world’s leading technology...Minimum wageFull timeWork at officeFlexible hours
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