...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 wet and dry conditions.
*...
Suggested
Hourly pay
Holiday work
Full time
Part time
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...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 wet and dry conditions.
ability...
Suggested
Holiday work
Full time
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...submission-related activities.
Deliverables: Perform activities supporting the fulfillment of PSPV’s expedited reporting obligations to US FDA.
Responsibilities – Ensure IND safety reports are uploaded in the correct format for Regulatory Affairs (RA). Ensure submissions...
Suggested
Full time
Work experience placement
Remote job
...reports, and any other supportive role information that is needed (RIS/PACS, burn discs).
Performs Quality Control (QC) needed for FDA/ACR.
Provides imaging support to other modalities in center (x-ray/ bone density, etc).
Works with mammogram letters (results/...
Suggested
...experts
Provide inventory management of computers, instruments and software. Maintains inventory management databases
Complies with FDA, EPA, OSHA and BI regulations and policies, completes all required training by due dates
Provide laboratory infrastructure support...
Suggested
Holiday work
Full time
Monday to Friday
...providing purified water design and implementation support for engineering projects and perform all documentation activities to comply with FDA/EU and GXP regulations and guidelines.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery,...
Suggested
For contractors
Weekend work
Weekday work
...prescribed in the sponsor SOPs and study monitoring plan;
Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations;
Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates,...
Suggested
Contract work
...company procedures / quality standards and ensure compliance with customer specifications and applicable external regulations (ex: OSHA, FDA).
Job Qualifications:
~ BS or MS in a related Engineering discipline
~5-year minimum CNC experience, strong Milling and Multi-...
Suggested
Temporary work
Immediate start
...of experience in GxP pharmaceutical facility with experience in engineering/facilities compliance management.
+ Deep knowledge of FDA and GxP requirements for Pharmaceutical Development (GLP) and Manufacturing (GMP) from the engineering/facilities perspective.
+ Compliance...
Suggested
Local area
...SOPs, Working Instructions (WI) and where applicable, departmental practices.
~ Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and...
Suggested
Hourly pay
Full time
For contractors
Work experience placement
Local area
Remote job
Work from home
Day shift
Monday to Friday
...in progress for completing BA/BS degree)
PM certification (CAPM, PMI, PMP, PRINCE2) recommended but not required.
1-2 years in an FDA regulated industry, particularly in a Quality Assurance department, preferred.
Familiarity with Project Management and Project...
Suggested
Contract work
For subcontractor
Relocation
...standard. Areas of focus include but are not limited to: statistical process control, performance metrics, customer management, ISO, FDA, and GMP compliance. This position will focus primarily on improving quality systems infrastructure in a contract manufacturing environment...
Suggested
Full time
Contract work
...discounts, market share and expenses.
+ Performs all Company business in accordance with all state and national regulations (e.g., EEO, FDA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policies and procedures.
+ When violations are noted/observed they are to be immediately...
Suggested
Local area
Immediate start
Night shift
...external sources.
Create, maintain, and update investigator, site, and staff data in CTMS based on the Regulatory documents (e.g. FDA 1572) and/or from a pre-designed template.
Update CTMS trial information related to investigators in the BIPI Investigator Database...
Suggested
Hourly pay
Full time
For contractors
Work experience placement
Work from home
Shift work
...Notices as well as key issues arising out of relevant federal and state agencies, in addition to self-regulatory agencies including the FDA, FTC, CMS, etc.
**Requirements**
**Sr. AD Senior Counsel:**
+ Juris Doctorate degree from an accredited law school
+ At least (...
Suggested
Contract work
Fixed term contract
Immediate start
Flexible hours
2 days per week
3 days per week
...to use and learn other system applications
Detail-oriented
Good problem-solving skills
Good customer-service skill and quality orientation.
Basic knowledge of ICH, GCPs, applicable FDA guidelines, and industry standards.
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Work experience placement
Local area
...SOPs, Client WIs and where applicable; departmental practices, and systems.
Maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets. PhRMA code, and...
Hourly pay
Full time
Work experience placement
Local area
Remote job
Shift work
Day shift
Monday to Friday
...Engineering with 8+ years industry experience.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.
Domestic and international travel will be required
Knowledgeable of and works within FDA,...
...physician. Exhibits strong anatomy knowledge, communication, computer skills, customer service, documentation review, proficient in FDA regulation and Medical Imaging. Reports to the Supervisor of the Unit. Duties and Responsibilities: Assist patient to procedure room....
Weekly pay
Temporary work
Local area
...knowledge of assigned BI SOPs and BI Working Instructions.
Maintain current knowledge of assigned role-based ICH and GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and...
For contractors
Work experience placement
Local area