GCP Auditing Consultant - Remote Job at MMS, Wilmington, DE

SktNN2EyUGptWXV5Q25nd0hNWDBRWDUwbHc9PQ==
  • MMS
  • Wilmington, DE

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 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

Job Tags

Remote job, Contract work,

Similar Jobs

The Staff Pad

Certified Medical Assistant (CMA) Job at The Staff Pad

 ...Certified Medical Assistant (CMA) Helena, Montana Schedule: Full-time, Day Shift Summary: The Staff Pad is proud to partner with a non-profit healthcare system in Helena, Montana, dedicated to providing exceptional care. This role involves delivering... 

Acentra Health

RN Sanction Specialist - EMTALA and Sanction (Remote) Job at Acentra Health

 ...for health solutions in the public sector. Acentra seeks an RN Sanction Specialist to join our growing team. Job Summary:...  ...maintaining compliance with EMTALA regulations. *Position is remote* Job Responsibilities: Maintain lines of communication... 

Safety & Security Services

Armed & unarmed security officers Job at Safety & Security Services

 ...Full time armed and unarmed positionsavailable. Two locations. The armed location iscurrently paying$17.50 per hr., the unarmed is paying $15 per hr.All positions require a CLEET security guard license. Growing multi-state business headquartered in Oklahoma. All... 

Contessa - Miami

Maitre D Job at Contessa - Miami

 ...Major Food Group (the powerhouse restaurant group behind Carbone, THE GRILL, Sadelles and more) is looking to continue building on their multi-dimensional, immersive concepts that transports their guests to new memorable experiences. We want to transcend traditional hospitality... 

Domino's Franchise

Delivery Driver - 1435 W South ST Job at Domino's Franchise

 ...staff stores in your area. We're growing so fast it's hard to keep up, and that means Domino's has lots of ways for you to grow (if...  ...ADVANCEMENT Many of our team members began their careers as delivery drivers and today are successful Domino's franchise owners. From...