Search Results: 102 vacancies
...Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
Host regulatory agent inspection such as FDA, EU QP, and DEA. Provide responses to ensure quality compliance.
Develop and approve quality agreements with client, host client audit...
Suggested
Full time
Contract work
Remote job
...points with a continuous improvement mentality.
Strategic planning for annual plans to ensure that the business complies with ISO, FDA, EPA, OSHA and all other legal requirements.
Drive rapid, significant and sustainable improvement in SQDC
Provide the...
Suggested
...approved SOP.
Responsible for maintaining a neat, clean, and safe working environment always.
Understands and adheres to all cGMP and FDA regulations.
Identifies and reports any quality issues to management or quality department.
Understands and adheres to all...
Suggested
Work experience placement
Local area
Immediate start
Shift work
...operate the organizational RIS and PACs systems. Maintain accurate time records. Follows the guidelines and regulations set forth by MQSA, FDA and ACR. Actively participates in patient follow ups.
Responsibilities:
Greet patients, identifies self and interacts with...
Suggested
Day shift
...assigned.
Other / Regulatory:
Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc.)
Flexible and readily adopts new processes and engages in practice operation changes....
Suggested
Holiday work
Full time
Local area
Flexible hours
Monday to Friday
...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
...experience practicing law, with a focus on biotechnology, pharmaceutical, medical device, and/or healthcare. Experience working with the FDA and a strong understanding of the laws and regulations related to the discovery, development, approval, sales, and marketing of...
Suggested
...pharmaceutical industry
* Experience in ophthalmology or vaccine studies in Phases 1-3 is a plus
* Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies
* Demonstrated attention to detail and outstanding organization skills
*...
Suggested
Local area
...improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
**Equal Employment Opportunity**
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants...
Suggested
Hourly pay
Contract work
Worldwide
Work alone
Flexible hours
...charges.
Other / Regulatory:
•Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc.)
•Staying current with communications from the Patient Access Management Team while remaining...
Suggested
Local area
Flexible hours
...techniques, 21 CFR (Code of Federal Regulations).
Must have knowledge and understanding of OSHA, NFPA, The Joint Commission, , EOC, FDA and other specific regulations and standards pertaining to clinical and radiology equipment service and repair.
Maintain up-to-...
Suggested
Full time
Local area
Shift work
...statistics required.
~5 to 8 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
~ Demonstrate ability to work independently in project management and decision...
Suggested
Work experience placement
...Provides review of technical, validation and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH and JP regulations/guidance.
Maintains Quality systems while ensures seamless and efficient efforts are applied to on-going...
Suggested
...software experience.
~ Demonstrated experience in ensuring that all solutions are in compliance with relevant quality regulations such as FDA and ISO preferred.
~ Experience in validating injected molded parts.
~ Ability to travel to vendor sites (US).
#LI-TH1...
Suggested
Full time
Local area
Remote job
Shift work
...Quality Control processes in the Bioanalytical Sample Management team.
* Maintain knowledge regarding phase I-IV clinical trials, FDA regulations/ICH guidelines, and other pertinent regulations.
Education, Experience & Skills Required:
Bachelor's degree or equivalent...
Suggested
Full time
Contract work
...CBSPD)
Association of perioperative Registered Nurses (AORN)
The Joint Commission (TJC)
U.S Food and Drug Administration (FDA)
Center for Disease Control (CDC)
Occupational Safety and Health Administration (OSHA)
Association for the Advancement of...
Shift work
...Ensure self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA, HIPAA, etc.)
Oversees the POCT process to ensure accuracy and compliance.
Report and act upon identified equipment/instrument...
Local area
...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+...
For contractors
Remote job
...Advanced-level understanding of quality management systems, including the writing of policies and procedures, auditing techniques and FDA regulations for clinical trial software
Experience hosting and/or conducting audits of computerized systems within a clinical...
Flexible hours
...demonstrate an in-depth understanding of GMPs, USP, EP, and ICH regulatory guidelines related to CMC activities.
* Knowledgeable in US FDA, EMEA, and HC regulatory analytical and QC testing requirements. Direct experience with CMC analytical requirements for IND/IMPD, NDA...
Contract work
