- UpvoteDownvoteShare Job
- Suggest Revision
Must possess a thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND, and other applicable regulations. The Senior Clinical Research Associate performs and coordinates aspects of field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical Standard Operating Procedures (SOPs.
Full-timeExpandUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Perform inspection in accordance with the FDA, ISO, and other applicable regulations. Job Title/High Level Position Summary : Receiving Inspector. Dimensional & visual inspection to drawings, using gauges and other reliant inspection equipment.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations. Good knowledge of FDA guidelines and review processes, IND and NDA processes, and GCPs; project management skills including client management, fiscal/contract management, and quality management; as well as strong time management skills and the ability to thrive in a stressful environment with multiple priorities.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Working with FDA in CMC aspects - tenure with products through multiple stage gates in the development process. We are seeking an Executive Director (flexible on title) of Process Sciences, CMC to join our small team in innovating regenerative medicine.
Full-timeExpandUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUauthorized, rapid PCR, point-of-care system. This individual will oversee all technical and product support facets of instrument manufacturing engineering operations, ensuring adherence to FDA regulations and GMP guidelines.
ExpandUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Knowledge of FDA & US Government regulations, including labeling & nutritional facts with use of Genesis Nutritional Software. BS. Degree in a related field of Food Science, Microbiology, Meat Science, Animal Science or Chemistry.
ExpandUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Quality assurance, gmp, sop, fda, audit, document control, laboratory, data entry, report writing, quality control, inspection, pharmaceutical, medical device. quality assurance, gmp, sop, fda, audit, document control, laboratory, data entry, report writing, quality control, inspection, pharmaceutical, medical device.
ExpandUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
RemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Review and approve validation documentation, including master validation plans, protocols, and reports, ensuring alignment with FDA/AAMI/ISO/EN guidelines and standards. As a Process Validation Engineer, you will play a critical role in evaluating the validation of equipment, software, and processes utilized in the development and production of medical products.
ExpandUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Familiarity with 21 CFR Part 11, FDA, and GCP requirements. College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
- Suggest Revision
Direct key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Experience in library construction for NGS, with emphasis on Process Development and optimization of diagnostic assays in a CLIA or FDA regulated laboratory environments is highly desired. Understanding of essential molecular biology methods such as PCR, nucleic acid purification, gel electrophoresis, analysis tools and instrumentation, DNA quantitation, and quality control are required.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Experience working within FDA & ISO manufacturing practices, preferred. Sew and assemble sewing cuffs to specification in a cleanroom environment. Inspect materials and components, in-process assemblies, and finished goods with aid of a microscope.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. Participate in the validation and verification of electrical systems to meet FDA and safety agency requirements and support the preparation of relevant documentation for regulatory submissions.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
- Suggest Revision
As a Clinical Research Coordinator, you will be responsible for orchestrating and overseeing clinical trials in accordance with FDA requirements and GCP guidelines. As a Clinical Research Coordinator, you will be responsible for orchestrating and overseeing clinical trials in accordance with FDA requirements and GCP guidelines.
Full-timeExpandApply NowActive JobUpdated 17 days ago
fda job in Austin, TX
FEATURED BLOG POSTS
Looking for New Candidates?
Before the turn of the century, recruiters could put their "help wanted" ads in the newspaper, and applications would pour in. Since then, recruiting has turned a new page. The use of the internet and other technologies allows recruiters to broaden their candidate pool for the simple reason being
Decline a Job Offer Professionally: When to Rescind
Your job search has finally paid off! After countless job applications, numerous emails, and several interviews, the hiring manager and other stakeholders have decided that you’re the right person for the job! All you have to do now is accept the offer and walk into the sunset, right?
Resume Job Description Samples - 8 Tips to Follow
When looking for a job, your resume becomes a crucial element. From making a great first impression to showcasing all your achievements and potential, your resume has to portray your professional story in minutes.
Internship Cover Letter Tips with Examples
Until now, college has been about learning, absorbing, and experiencing. It’s not until you become eligible for an internship that things start getting real—real-world experiences using real-life scenarios. Applying for internships takes time, and there’s no college course on “how to apply for jobs.” (We’d sign up immediately if there was, though!) But here's a spoiler alert: most internships require a cover letter. And while this may seem like a burden, it’s actually a blessing.
5 Practical Ways to Remove Bias from your Hiring Process
Many employers think their hiring process is perfect. However, research shows that the hiring processes are generally impartial and unfair, especially if you are part of certain demographics. Women, people of color, people with disabilities, or even people in lower socioeconomic status are more likely to be subject to implicit bias. As diversity and employer branding become major aspects of business, it is important that employers take the lead to identify and remove bias from the hiring process. So, here are 5 practical ways to get you started.
Tips to Get Your First Job Confidently
Whether you’re a recent graduate or you still have a few exams left, you may be itching to put your polished leather shoes on and join the workforce. After all, your first job is an entryway into the professional life you’d lead for the decades to come.
Tips for a Good Character Reference Letter with Examples
Hiring managers love a resume laden with relevant skills and qualifications. Hard skills specific to the role, like SEO strategy or Java programming languages, are easy to qualify using achievements or facts and figures. But how exactly can they verify personality traits, work ethic, relationship management skills, or curious nature during an interview when they barely know you?