Search Results: 263 vacancies
...writing, editing, and proofreading skills with keen attention to detail.
Strong understanding of regulatory requirements, including FDA and GMP.
Experience with process mapping and flowcharting tools.
Proficiency with document management systems and Microsoft...
Suggested
Permanent employment
Temporary work
Remote job
...writing, editing, and proofreading skills with keen attention to detail.
Strong understanding of regulatory requirements, including FDA and GMP.
Experience with process mapping and flowcharting tools.
Proficiency with document management systems and Microsoft...
Suggested
Remote job
...Description
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Food Safety and Applied Nutrition (CFSAN), located at Raleigh, North Carolina...
Suggested
Full time
Contract work
Summer internship
Flexible hours
$28.65 - $44.27 per hour
...Degrees, Licensure, and/or Certification
ARRT certification in radiography
ARRT advanced certification in mammography
FDA/MQSA qualified to include meeting the MQSA CE requirements of at least 15 CEUs in a 36 month period that must include at least 6 CEUs...
Suggested
Full time
Relief
Saturday
Monday to Friday
**Company :**
Highmark Inc.
**Job Description :**
**JOB SUMMARY**
This job works in a team oriented environment monitoring FDA-approvals, drug manufacturer pipelines, and assess drug utilization reports, in order to develop and execute the the Organization's Drug...
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For contractors
Local area
...Qualifications:
Education: High school degree or GED required.
Minimum of 5 years' experience with equipment maintenance in an FDA compliant manufacturing environment required.
Specific work experience required in use of Vision systems, electrical...
Suggested
Work experience placement
Shift work
Rotating shift
...healthcare by moving care delivery to the home through the company's spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists, and family members digitally.
The...
Suggested
Local area
Remote job
Flexible hours
...validation resource with periodic review, audit experience.
We are 10 + years Experience in Validating GxP applications.
Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy.
Provides consultation...
Suggested
Permanent employment
...make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus...
Suggested
Local area
Flexible hours
Night shift
....
* Works with Labeling Strategy staff to ensure compliance with US Labeling processes.
* Must be able to effectively articulate FDA and GSK requirements for labeling documents to GSK matrix teams, champion change, and recommend unique solutions, as needed.
* Ensures...
Suggested
...blood collections procedures.
~ Training is performed in accordance to departmental procedures, processes, policies along with FDA and AABB regulations/standards and training records are maintained in a method that ensures completeness and accuracy.
~...
Suggested
Hourly pay
Temporary work
Traineeship
...functional department as they apply to documentation and validation of clinical research statistics. Understands guidelines from the FDA, ICH, EMEA, NIH, or other regulatory agency as they apply to statistics and programming expectations for each project
Manages project...
Suggested
Work experience placement
...ISO microbiological methods such as USP 797, 61, 62, 71, 85, and ISO 14698
~ Strong understanding of regulatory requirements (e.g., FDA, EMA) and industry standards related to microbiological QC testing.
~ Experience with validation and qualification processes, including...
Suggested
Holiday work
Full time
Work experience placement
Flexible hours
...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 a flexible schedule including...
Suggested
Holiday work
Full time
Part time
Flexible hours
Shift work
Night shift
Sunday
Saturday
...utilities, validation, and microbiological monitoring.
~ Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU, and other regulatory agency guidelines, including direct experience completing Quality Assurance function and system within a...
Suggested
Summer work
Seasonal work
Local area
Flexible hours
...with team and supports process improvements
Ability to read and execute compendial methodologies
Strong understanding of current FDA and cGMP regulations
General knowledge of chemistry and scientific calculations
Hands on experience in analytical techniques...
...Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system...
Holiday work
Temporary work
...Write software requirements for the host application and software tools
Provide design input for GUI of system software
Ensure FDA compliance of all software and potential Web-based applications
Responsible for design, development and implementation of cybersecurity...
Permanent employment
...assigned site.
Inspection readiness may include periodic internal audits, client audits, or any external agency
inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality
representative during external agency or client...
...with departmental Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) guidance and applicable regulations including FDA 21 CFR part 11.
Job Responsibilities:
1. Interact with product management, project management and development teams to develop...
Permanent employment
Contract work
Work experience placement
Remote job
