Search Results: 169 vacancies
...possibility of extending or converting to permanent.
Work Schedule - 7:30am-4:00pm M-F
Responsible for maintaining compliance with FDA, AATB, international and state regulations during the second level quality review of all tissue donor files for tissue submitted to...
Suggested
Permanent employment
Contract work
...which will impact the quality and duration of life.
Job Description:
Responsibilities:
Responsible for maintaining compliance with FDA, AATB, international and state regulations during the second level quality review of all tissue donor files for tissue submitted to...
Suggested
Permanent employment
...and perform all functions associated with commercial and clinical manufacturing and packaging and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations.
Oversees unit operations consisting of and not limited to Hot Melt Extrusion, Fluid Bed, high...
Suggested
Holiday work
Permanent employment
Full time
Local area
Worldwide
Shift work
Afternoon shift
Monday to Friday
...skills, including proficient knowledge of medical terminology
Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
EDC experience in multiple systems
Ability to deliver results and execute...
Suggested
Permanent employment
Contract work
...with clinical trial data
Advanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
Experience in handling and processing upstream data, e.g., EDC, eDT, SDTM, and in providing outputs to meet downstream...
Suggested
Permanent employment
...will ensure that study execution is performed in line with the Code of Federal Regulations (CRF) of the Food and Drug Administration (FDA) and the International Conference of Harmonization - Good Clinical Practice (ICH-GCP).
Job Responsibilities:
Prepares and...
Suggested
Interim role
Local area
2 days per week
1 day per week
...visibility to the reporting and where they are in the process
Manages regular reporting needs and external requests (i.e. from the FDA)
Manage the timeline for end to end reporting
Owns translation services for reporting
Qualifications
~ Bachelor’s Degree...
Suggested
Holiday work
Full time
Temporary work
Work experience placement
Local area
...and enzymes for complex diagnosis and prognostic markers Contribute to corporate strategy for additional regulatory approvals (CAP, FDA, ) relating to GHI Histopathology Assess the quality of slide preparations and troubleshoot procedures if necessary Prepare control slides...
Suggested
Permanent employment
Full time
...The ideal candidate will have:
BS in Engineering or Science related discipline required
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity...
Suggested
Hourly pay
Contract work
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours
...progressive operations experience including a mix of Production, Warehouse, and Maintenance.
Must have previously worked in a FDA regulated industry and should have 3+years of Manufacturing/Engineering experience in cosmetic/personal care/OTC and contract...
Suggested
Contract work
Shift work
...procedures is required.
Experience with tube test blood typing is preferred.
Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP is preferred.
Manual dexterity to handle multiple tubes, complete repetitive motions, and stand for long...
Suggested
...component material etc.); analytical development studies for pMDIs and DPIs following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
Supervise and lead the execution of analytical activities required for regulatory submission including...
Suggested
...Investigation Review Meetings (FIRM).
Supports product recalls and executes plan as assigned.
Represent Company during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements.
Assist with...
Suggested
Contract work
Remote job
...Familiarity with the use of balances, pipettes, and HPLCs in the laboratory.
~ Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP).
~ Experience in reviewing data for accuracy and compliance with...
Suggested
Hourly pay
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours
...Regulatory Compliance processes which include but are not limited to the activities listed below. Ensures the organization’s compliance with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices, the harmonized...
Suggested
Holiday work
Full time
Temporary work
Work experience placement
Local area
...over time as required.
~ Bachelor's degree in Medical Technology, Biology
~ Familiarity with the guidelines and regulations of FDA, OSHA, ISO, and cGMP is preferred.
~ Manual dexterity to handle instruments, complete repetitive motions, and stand for long...
Shift work
Weekend work
...tests, and rejecting and returning unacceptable materials.
Verify that the Certificate of Analysis is provided by the Supplier and FDA documents have been released for imported products.
Document inspection outcomes by completing detailed reports and entering data...
Full time
Immediate start
...Required Qualifications:
BS in Engineering or Science related discipline required
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity...
...good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.
What You'll Do
Write C/Q/V documents following established standards and templates, including but not...
Work alone
Night shift
...determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)
Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product...
Worldwide
