GCP Auditing Consultant - Remote
Job Description
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?
MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate.
We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges.
With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.
Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.
com or follow MMS on LinkedIn.
This role is a project-based consulting opportunity.
Responsibilities :
- Independently conduct vendor qualification audits and / or investigator site audits including relevant audit documents such as : audit plan, audit report and debrief presentations
- Vendor oversight and monitoring, as needed
- Experience with performing investigations of errors investigations and risk assessments
- Experience with hosting and interacting with regulatory authorities during an inspection
Requirements :
- Minimum 5 years of experience in GCP auditing role within the CRO, Pharma, or Biotech industry
- Bachelor’s Degree in a scientific, medical or clinical discipline
- Travel may be required for onsite audits
- Expert knowledge of scientific principles and concepts
- Proficiency with MS Office applications
- Hands-on experience with clinical trial and pharmaceutical development
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Excellent problem-solving skills
- Good organizational and communication skills
- Familiarity with current ISO 9001 and ISO 27001 standards preferred
- Proficient experience with 21 CFR Part 11, FDA, and GCP requirements
- Basic understanding of CROs and scientific and clinical data / terminology, and the drug development process
Powered by JazzHR
mFPhLu7vTb
GCP Auditing Consultant - Remote
Responsibilities: Independently conduct vendor qualification audits and/or investigator site audits including relevant audit documents such as: audit plan, audit report and debrief presentations Vendor oversight and monitoring, as needed Experience with performing investigation...
Full Time Teller Aurora City Center
Are you looking for more? Find it here.At Wells Fargo, we believe that a meaningful career is much more than just a job.It's about finding all of the elements that help you thrive, in one place.LivingTheWellLife means you're supported in life, not just work.It means having a competitive salary, a ro...
Special Education - School District Teacher Assistant
Hiring multiple candidates, Easy Apply, Part Time.We are looking for a part-time paraprofessional to work with K-12 special education students across Denver.As a paraprofessional, you will support licensed teachers with academic adaptations, self-care, and social/behavioral needs of students in thei...
Field Report Specialist
Elevate Your Career with Millennium!.FIELD INSPECTORS WANTED – Join the Winning Team!.Are you ready to take your career to new heights?.Millennium Information Services is on the rise, and we want YOU to be a part of our success story!.As the go-to national provider for property inspection serv...
Child Care Teacher- Aurora, Colorado-Fitzsimmons
Imagine your future as a teacher with a world-class team where you make a difference for children every day.Imagine learning from experts in your field, and having the opportunity to earn your college degree - for free.Imagine it all as a Bright Horizons Teacher.Full-time positions now available wit...
Account Development Specialist - Proximo (On-Premise - South Metro))
Account Development Specialist - Proximo (On-Premise - South Metro)).The Account Development Specialist is responsible for maximizing the sales and marketing of .This role must maintain strong relationships with the key stakeholders/gatekeepers of the supplier accounts and be the 'go-to' consultant ...
Member Service Representative (Part-Time) - Aurora
To provide members and prospective members the full range of products and services offered by Navy Federal Credit Union including depository accounts such as checking, savings, certificate IRA, revocable trust and estate accounts; lending products; and credit/debit cards.To perform advanced platform...
Client Service Associate (Teller) 40 hours - Grand Junction, CO
At Vectra Bank, the Rocky Mountain region is a part of who we are, and we understand why families and businesses choose to live, grow, .Recently recognized as one of the .Denver Posts Top Workplaces for 2022.Vectra Bank Colorado offers our customers, and our employees, the best of both worlds: a bro...
Seasonal Business Tax Associate
At Intuit we believe everyone should have the opportunity to prosper, which is why our mission is Powering Prosperity Around the World.Being a mission-driven company includes living our values everyday and nothing is more important to us than the success of our customers.You will be working toward a...
Shift Leader - 8475 Yosemite St.
Do you hunger for more? Potbelly Sandwich Shop is looking for friendly and outgoing people who enjoy working in a fast-paced, friendly environment.We are where good vibes and great careers are a way of life! What started as a small antique store in 1977 has become a nationally recognized neighborhoo...