Quality Assurance Auditor (Project-Based)

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 to conduct vendor audits on an as-needed basis. This is not a full-time position.

Responsibilities: 

• Independently conduct GMP/GLP/GCP vendor qualification audits to include, but not limited to, manufacturing, labeling, packaging, analytical and/or clinical testing, or investigator sites 
• Create audit related documents including audit plans and reports
• Collaborate with vendors and sponsors to plan and implement an audit schedule
• Oversee and monitor CAPA process
• Experience with hosting and interacting with regulatory authorities during an inspection

Requirements:

• Minimum 10 years of experience in GMP/GLP/GCP auditing role within the CRO, Pharma, or Biotech industry
• Bachelor’s Degree in a scientific, medical or clinical discipline
• Travel required for onsite audits 
• Experience with hosting and interacting with regulatory authorities during an inspection preferred
• Must be knowledgeable in 21 CFR Parts 11, 210, 211, and 820
• Must have extensive experience auditing GMP, GLP, or GCP facilities including DP/DS and/or device manufacturing and QC or clinical laboratories, or investigator sites 
• Expert knowledge of scientific principles and concepts
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development            
• Excellent communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Proficient experience with FDA and GMP requirements
• Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process