Senior Quality and Compliance Specialist (GCP Site Auditor)

Company: MMS
Location: Cleveland
Posted on: May 25, 2023

Job Description:

MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in -Global Health & Pharma's -international awards programs for the last three consecutive years. For more information, visit - -or follow MMS on -.Job Specific Skills

• Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
• Understanding of how to plan, prepare and -conduct GCP audits -independently.
• Proficient in authoring and managing audit documents independently.
• Proficient in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. independently.
• Experience supporting QA/ QMS activities.
• Develop CAPA plans and contribute to resolution of audit findings independently.
• Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
• Assists in other duties relating to Quality Management Systems and overall compliance within Quality and Compliance department, as requested.
• Lead and support business development and capabilities activities independently.
• Must be willing to travel up to 50% of the time for audits within the US.Requirements
  • College graduate in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.
  • Minimum of 5 years' experience in -GCP regulated industry (i.e., Clinical Research Coordinator, CRA, Laboratory Associate, QA, etc.).
  • Expert knowledge of scientific principles and concepts. -
  • Reputation as emerging leader in field with sustained performance and accomplishment.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • 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 with 21 CFR Part 11, FDA, and GxP requirements.
  • Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.Powered by JazzHR

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