Search Results: 104 vacancies
...efficiently
Maintain Manual Re-Packaging room cleanliness and orderliness
Follow all applicable government regulations including HIPAA, FDA, DEA, OSHA, etc.
Ensure the integrity of the drug supply chain through best practices
Display behavior which exemplifies...
Suggested
Holiday work
Full time
Temporary work
Part time
Shift work
...bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The Project Engineer will work with surgeons and all other...
Suggested
...Organize sample distribution/shipment
Coordinate testing at various sites for reagent qualification or requalification
Comply with FDA, EPA, DEP, DOT, OSHA, and client regulations and policies
Provide superlative service to clients by performing duties accurately...
Suggested
Permanent employment
...wait.
Position Summary :
The Assembly Technician is responsible for assembling medical devices in compliance with applicable FDA, state, OSHA, and ISO regulations and standards. The job requires the individual to be a team player with the ability to function...
Suggested
...direct strategy for regulatory compliance for all CSL Plasma Inc Operations to include:
o Authorized Official contact e.g., with FDA and other health authorities.
o Serve as a liaison/representative for our submission to regulatory agencies.
o Serve as the primary...
Suggested
Contract work
Summer work
Worldwide
...Experience in study management, clinical-ops, human biological sample management and related process development.
~ Knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives.
~#LI-Hybrid
Our Benefits CSL employees that work at least 30 hours...
Suggested
Summer work
Worldwide
...experience in IT & Quality in a regulated medical devices realm
2-3 years in software management or other IT environments subject to FDA or other government regulations.
2-3 years of hands-on experience in software validation and managing validation strategies
1+...
Suggested
For contractors
Remote job
Fine-Tune Your Search!
Filter the job list with Smart Tags that match your preferences
Internship(20)
Weekly pay(23)
Immediate start(71)
Windows(18)
Work Overtime(29)
Monday to Friday(36)
Weekend work(51)
Afternoon shift(36)
Temporary work(65)
Night shift(54)
...conducting and reporting all types of quality assurance audits
Auditing experience in USA
Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
Team oriented with superior communication and interpersonal skills
Strong...
Suggested
Local area
Flexible hours
...platform, with a focus on cost control.
6. 5% - Leads plant inspections and audits to verify plant compliance to Pepperidge Farm, FDA and Safe Quality Foods Institute (SQF) regulations and standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Provides technical expertise...
Suggested
Hourly pay
Full time
For contractors
Gangs
Shift work
All shifts
...needs of the business.
-Strong understanding of any of the following : 21 CFR Part 11, 210, 211, 820(Quality System Regulations) , FDA, Risk Assessment, GAMP 5,SCADA Analysis, Remediation, Retrospective Validation, Change Control, CAPA.
-Successful individuals will...
Suggested
Holiday work
Full time
Local area
...alignment of QC priorities with the site priorities/strategy, also ensuring strategy deployment.
Leader in the Audit Room for ISO Audits, FDA Audits, Supplier Audits, and other applicable regulatory or non-regulatory body audits.
Inspect, test, or measure raw materials...
Suggested
Local area
...Agreements and work on Data Reconciliations.
6) Use StudyDoc to generate report templates and prepare Watson result tables
7) Client/FDA Audit Support
Essential Duties & Responsibilities
List below the major areas of responsibility of the job in descending order...
Suggested
Full time
Contract work
Night shift
Weekend work
...degree of accuracy.
* Ability to take instructions from various sources and prioritize tasks.
* Maintain familiarity with relevant FDA/ICH guidelines and regulations as needed.
* Must possess excellent technical administrative and communication skills.
*...
Suggested
Holiday work
Local area
...labeling regulations for assigned licensed products. Review or reject promotional programming based on US Code of Federal Regulations, FDA's implementing regulations and guidelines established by Health Canada. Follow related SOPs and work instructions for established...
Suggested
Summer work
Worldwide
...Understands Process FMEAs and Process Validations (IQ, OQ, PQ)
Understands project plans and the launch life cycle
Understands FDA compliance around validations, gauging, Device History Records in design and in manufacturing
Understands RCCA, CAPA's, DFMEA, PFMEA...
Suggested
...responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products. This position entails management of submissions to the FDA, requiring working knowledge of products...
...Experience:
Bachelors degree in a biological science or related field preferred.
1 year of quality experience in an FDA regulated environment for HCT|Ps and|or medical devices preferred.
Salary:
$55k-$65k (Depends on Experience)
Benefits:...
Full time
...required
+ Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices
+ Sterile/biologic/ATMP/C...
Holiday work
Local area
Worldwide
...contract to possible perm role that must be worked on-site.
Job Requirements:
Bachelors Degree in Mechanical Engineering
3+ years of mechanical engineering and design for medical devices
FDA compliance knowledge
Solidworks
#PRI
Permanent employment
Contract work
...bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work with spine surgeons and all other...
