Search Results: 44 vacancies
...materials to growth and quality attributes. GMP experience is a huge plus - someone who has dealt with regulatory inspectors/auditors (FDA, other regulatory agencies from other countries)
Top 3 Must Have Skill Sets:
Must have at-scale biologics cell culture...
Suggested
Remote job
2 days per week
3 days per week
1 day per week
...industry in Puerto Rico & USA.
Responsibilities
Responsible for providing facility/equipment cleaning, and sanitation, in support of FDA regulated manufacturing areas.
All work to be completed to assure minimal impact to production while complying with Standard...
Suggested
Shift work
Day shift
...Technology (MSAT) as Final Product Technical Lead
+ Support Pre-Approval Inspections, Audits, and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed
**Win**
**What we expect of you**
We are all different, yet we all use our outstanding contributions to...
Suggested
Remote job
Worldwide
Flexible hours
...Requirements: Remedy Onboarding completed (Steps provided in branch) Ability to stand for along period of time in a designated area Due to FDA regulations a stringent dress code must be adhered to:No jewelry, no makeup, no false lashes, no nail polish, no acrylic nails, and...
Suggested
Weekly pay
Permanent employment
Temporary work
Immediate start
Shift work
Day shift
Monday to Friday
...immediate release and controlled release oral solid dosage drug products.
+ Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, early phase development, etc...
Suggested
Contract work
Immediate start
Remote job
Worldwide
Flexible hours
...organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Clinical Research Coordinator collaborates with the...
Suggested
Hourly pay
Remote job
Flexible hours
Monday to Friday
...plans, to provide technical and strategic advice, and to meet milestones and budgets.
* Strong knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
* Ability to effectively evaluate outside expert advice.
* Ability...
Suggested
Local area
Remote job
Flexible hours
...important projects aimed at helping people with serious medical conditions live life more humann.
Key Responsibilities:
* Manage the FDA website ClinicalTrials.gov to ensure compliance and accuracy of trial information.
* Utilize data mining techniques to extract and...
Suggested
Full time
Temporary work
Internship
Monday to Friday
...agency organization, guidelines, and practices and ability to negotiate with these groups
+ Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
+ Understanding of new drug commercialization and...
Suggested
Remote job
Worldwide
Flexible hours
...agency organization, guidelines, and practices and ability to negotiate with these groups
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Understanding of new drug commercialization and...
Suggested
Full time
Remote job
Worldwide
Flexible hours
...and pulling
Occasionally access high storage shelving with the use of a step ladder
Lift and carry up to 35 lbs.
Exposure to FDA-approved cleaning chemicals
Exposure to varying temperatures, including freezers, refrigerators, indoor air conditioning and...
Suggested
Hourly pay
Holiday work
Part time
Casual work
New year
Outdoor
Flexible hours
Day shift
Afternoon shift
...centers, Greenbrook is a leading provider of Transcranial Magnetic Stimulation ("TMS") therapy and Spravato® (esketamine nasal spray), FDA-cleared, non-invasive therapies for the treatment of Major Depressive Disorder ("MDD") and other mental health disorders, in the...
Suggested
Local area
Night shift
Weekend work
...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
Holiday work
Full time
Flexible hours
Night shift
...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
...materials to growth and quality attributes. GMP experience is a huge plus - someone who has dealt with regulatory inspectors/auditors (FDA, other regulatory agencies from other countries)
Seeking a Process Development Engineer to join the Drug Substance Technology...
Suggested
Contract work
Temporary work
Immediate start
Remote job
Worldwide
2 days per week
3 days per week
1 day per week
...and pulling
Occasionally access high storage shelving with the use of a step ladder
Lift and carry up to 50 lbs.
Exposure to FDA-approved cleaning chemicals
Exposure to varying temperatures, including steam, high kitchen temperatures, humidity, freezers,...
Hourly pay
Holiday work
Full time
Casual work
Outdoor
...field
* 2+ years of relevant work experience in operations/manufacturing environment
* Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
* Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech...
Contract work
Temporary work
Work experience placement
Immediate start
Worldwide
Relocation
Flexible hours
...communication and technical writing skills with cross-functional groups (QA, MFG., Leadership).
Direct experience in regulated environments (FDA, OSHA) with an emphasis on promoting safety and quality
Bachelor's degree in engineering or another science-related field with 5+...
Hourly pay
Holiday work
Full time
Contract work
Work experience placement
...communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)
Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.
Bachelor's degree in engineering or another science...
Work experience placement
Relocation
...performance qualifications of: Vial Washers, Depyrogenation Tunnels, Isolators, Sterile Fillers and Cappers
~7+ years of relevant FDA regulated industry experience
~ Knowledge of cGMP, good documentation practices and other regulatory standards
~ Exceptional technical...
Permanent employment
Full time
