...QMS), Environmental Management Systems (EMS), and other regulatory requirements
+ Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive...
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Shift work
Afternoon shift
...fairs. Successfully completes one community outreach and/or physician marketing per quarter.
Comply with all State license laws, FDA guidelines, WSA policies and HearUSA Quality Practice Guidelines (QPG). Operates in a HIPAA compliant manner, with documentation, outcome...
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Traineeship
Local area
Relocation package
...of Microsoft Office applications
Working knowledge of warehouse / mechanical equipment
Working knowledge of OSHA, DOT, HAZMAT, FDA regulations and the willingness to become certified in one or more of these areas as necessary
Excellent talent management and team...
Suggested
Hourly pay
Holiday work
For contractors
Seasonal work
Shift work
Night shift
Monday to Friday
...principles including USP 795, 797, and 800.
Knowledge of cGMP relative to USP guidelines; 21CFR Parts 210 and 211, ICH guidelines, & FDA requirements for APIs and drugs
Possess excellent written, and verbal communication and presentation skills
Your analytical...
Suggested
Full time
Immediate start
Flexible hours
Shift work
Monday to Friday
...their tenure or experience elsewhere.
Knowledge
*Proficiency in a body of information required for the job*
*e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.*
Able to understand technical issues (medical, computer, data...
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Night shift
...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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...a Juris Doctorate recipient of an accredited law school.
You have five years of corporate/business and advertising law, FTC, and FDA experience.
You have five or more years in privacy law preferred.
You're a collaborator who thrives in a team environment while...
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Worldwide
...maintain a safe environment for all employees, residents, families, and visitors, Stellar strongly encourages its employees to receive an FDA-approved COVID-19 vaccination, as well as any subsequent booster doses, as recommended by the Centers for Disease Control and...
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Local area
Flexible hours
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...products may move from a laboratory developed test (LDT) designation to a Medical Device/In Vitro Diagnostics classification governed by FDA. Overall, the Director is responsible for day-to-day operational implementation of activities for regulatory compliance across the...
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3 days per week
...with the required record-keeping, shipping, ordering, and inventory activities for investigation drugs to meet sponsor requirements, FDA regulations and legal requirements for pharmacy operations. Oversees pharmacy students and residents, interns and technicians in the...
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Part time
Immediate start
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Monday to Friday
...coding, testing)
Experience with Software Quality and Risk Management standards in medical devices, such as: IEC 62304, MDR 2017/745, FDA 21 CFR 820, ISO 13485, and ISO 14971.
Software development or engineering experience with medical device or other regulated field....
Suggested
...including but not limited to, data collection, cleaning, analysis, biostatistics and statistical programming, clinical study reports (CSR), FDA reports, abstracts, and manuscripts.
Ensure staff produce clean and valid clinical trial data for delivery to Sponsors through...
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Contract work
...management, and archiving activities as assigned. They will help transition paper records to online electronic binders in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices and manage the collection and distribution of...
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Temporary work
Part time
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Monday to Friday
...Responsibilities
-The Quality Assurance Coordinator performs ocular and tissue donor record quality assurance review in compliance with org, FDA, EBAA, and AATB policies, procedures, regulations, and standards
-This position facilitates requests from hospitals, medical...
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Work experience placement
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...thoroughly familiar with GMP regulations for the life sciences industry. We are currently looking for someone who used to work for the FDA and/or has extensive experience with mock FDA Audits.
As an SQA Quality Auditor, you will have at least four years’ experience and...
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...maintain a safe environment for all employees, residents, families, and visitors, Stellar strongly encourages its employees to receive an FDA-approved COVID-19 vaccination, as well as any subsequent booster doses, as recommended by the Centers for Disease Control and...
Holiday work
Full time
Local area
Shift work
...management, department and intra-departmental meetings and quality improvement activities.
+ Adhere to all accreditation, OSHA , FDA , state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment.
Qualifications...
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Temporary work
Local area
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...include the training in advanced career skills such as grant writing for NIH and regulatory work with the Food and Drug Administration (FDA). Future career goals for the applicant (towards the end of a multi-year training period in the Oklu lab) may include a transition to...
Full time
Temporary work
...PREFERRED QUALIFICATIONS:
Associates or Bachelor’s Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical,...
Minimum wage
Holiday work
Full time
Temporary work
Traineeship
Local area
Remote job
Relocation
Shift work
Afternoon shift
$145k - $170k
...with contract manufacturers.
CAD Systems and developing drawing standards.
Knowledge of regulatory compliance, HIPAA HITECH, ISO, FDA, NIST, AAMI TIR57, and FDA system validation.
Proficient computer skills in Email, Word, Excel, Power Point.
Possess strong...
Full time
Contract work
...clinical trials, including clinical operations, patient engagement and regulatory affairs
Execute research protocols according to FDA regulations and GCP guidelines
Evaluate patients eligibility for clinical trials
Adhere to industry standards and training programs...
Permanent employment
Relocation
Outdoor
...Requirements:
Familiar with Data Integrity and GDP in a cGMP Laboratory environment.
Theoretical knowledge of subject matter, cGMP, FDA guidelines, GLP and USP’s. Complete knowledge of good analytical and laboratory techniques, basic knowledge of cGMP’s, GLP’s, SOP’s,...
Full time
**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...
For contractors
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...Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines is required. Coordinates and schedules subject study visits to ensure adequate supplies, procedures and...
..., sampling, and storage of plasma collected from donors. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
**Key Accountabilities**
1. Follows all Standard Operating Procedures (SOPs) and regulatory policies and procedures,...
Holiday work
Immediate start
Flexible hours
...spelling; language and style consistency; accuracy; sense/clarity; required copy
Ensures relevant standards (eg, client/brand, AMA, FDA) are met
Is knowledgeable of and remains current on FDA guidelines
Creates and maintains editorial style sheets for each...
Remote job
...Quality Control analyses/functions in the processing of raw materials to finished goods and ensure compliance to company, customer, FDA, DOC, USDA and GMP specifications and regulations.
* Perform the Quality Control functions of production lines and/or the Quality Control...
Holiday work
Worldwide
Shift work
..., and sanitation process
Ensure compliance with customer specifications and quality standards (e.g. Food and Drug Administration (FDA), United States Department of Agriculture (USDA), HACCP, etc) and follow up with corrective actions if necessary
Ensure the kitchen...
Contract work
Local area
...institutional requirements.
Position Duties
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the...
...and care of the donor during the plasmapheresis process. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
Key Accountabilities
# Follows all Standard Operating Procedures (SOPs) and regulatory policies and procedures, employee...
Holiday work
Flexible hours