Search Results: 303 vacancies
...risk
Noncritical-Sensitive (NCS)/Moderate Risk
* Trust determination process
Suitability/Fitness
* Announcement number
FDA-ORA-24-RG-12388601-WW
* Control number
787388800
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This job is open to
* Recent graduates
Individuals who have graduated...
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...Title XXII, United States Department of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and United States Pharmacopeia (USP).
Job Shift:
Days
Schedule:
Full Time
Shift Hours:
8
Days of the Week:...
Suggested
Hourly pay
Full time
Immediate start
Shift work
Weekend work
Monday to Friday
...knowledgeable of, biopharmaceutical processing techniques
Advanced knowledge of process development activities, cGMP's guidelines and FDA and EMEA process validation requirements
Experience in dealing directly with customers and sales organizations on capital projects...
Suggested
Local area
Relocation package
Flexible hours
...public health and safety measures, EXOS requires that all successful applicants shall be required to show proof of full vaccination by an FDA-approved COVID-19 vaccine before beginning employment, unless an exemption from this policy has been granted as an accommodation or...
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Worldwide
...Good Manufacturing Practices (cGMPs), established cleaning policies and procedures, to maintain compliance with quality standards and FDA regulations. The incumbent plays a critical role in assuring sanitary conditions of the controlled areas are maintained, to allow for...
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Holiday work
Full time
Local area
Night shift
Weekend work
Day shift
Afternoon shift
...or High School diploma with 2-4 years related experience.
Experience in a pharmaceutical, medical device, bioscience, or other FDA-regulated environment required.
Must be familiar with cGMP and FDA requirements.
Knowledge of aseptic techniques helpful....
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Local area
Immediate start
...engineering/science principals and laboratory skills.
Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements.
Experienced in one or more of the following: Electro-mechanical, software, mathematical,...
Suggested
Local area
Shift work
...Working knowledge of IVD regulations, such as IVDR and IVD quality strategy is a plus
GLP experience is a plus
Understanding of FDA + Global regulations and Guidance for GLP/ GCLP, and how to apply them
Must have experience advising business in a compliance...
Suggested
...industry is required.
Strong utility and facility commissioning, qualification and validation experience.
Experience with FDA compliance and cGMP is required.
Must be results oriented with several years of hands-on experience, familiar with industry concepts...
Suggested
...Practices (GLPs).
Demonstrates working knowledge of quality assurance systems, methods and procedures.
Demonstrates knowledge of FDA / EMEA standards and quality systems.
Demonstrates basic knowledge of six sigma, LEAN and root cause analysis tools used for...
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Contract work
...standards for medical device development and in vitro diagnostic device (IVD) including but not limited to ISO 13485, ISO 14971, and FDA Guidance for medical device development.
Experience in performing complex engineering calculations and relating results to design...
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Local area
Shift work
...abilities
Good computer skills are required
Working knowledge of MS word, Excel, Power point is a plus
Experience working in an FDA regulated environment is highly desired
Must be willing to work as part of a team and demonstrate good interpersonal skills...
Suggested
...required.
Knowledge of combination product packaging and associated regulations and familiarity with design controls.
Knowledge of FDA and cGMP standards is required.
Strong verbal, written, and interpersonal communication skills are required.
Strong computer...
Suggested
Contract work
Night shift
...software or application development, including software architecture knowledge.
+ Experience with medical device systems development per FDA and EU design control regulations.
+ Experience with model based systems engineering (MBSE), UML, and SysML
+ Demonstrated...
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Local area
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work in a wet and cold environment....
Suggested
Hourly pay
Holiday work
Full time
Traineeship
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...partnership between QuantumLeap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 40 major cancer research centers across the United States and Canada.
The CRC will perform independently...
Local area
...International Standards, such as ISO13485, IEC60601.
Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
Ability to manage...
...experience
? Help to implement, monitor, and promote good practice of all Quality Assurance Systems to
ensure compliance with relevant FDA, EMA/other regulations/directives/requirements and ICH
guidelines
? Establish and oversee required phase-appropriate GxP systems...
Remote job
Flexible hours
...policies in a major segment of the company
+ Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, EFSA, CODEX regulations, GMP etc.)
+ Makes and executes operational decisions with a strategic perspective
+ Indirectly controls...
...manager/trial or project manager level required.
~ Experience conducting vaccine clinical trials a plus.
~ Thorough understanding of FDA, ICH and GCP guidelines.
~ Strong organizational, documentation and interpersonal skills as well as a willingness to work within a...
Holiday work
Remote job
Flexible hours
