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3 MMS Holdings Jobs
Senior Quality and Compliance Specialist
MMS Holdings
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
- 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 overall compliance within Quality and Compliance department, as requested.
- Must be willing to travel up to 30% of the time for audits within the US.
- College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years experience in GCP regulated industry if not a college graduate
- Minimum of 5 years experience in GCP regulated industry (ie, Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
- Expert knowledge of scientific principles and concepts.
- 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.
- Proficient with 21 CFR Part 11, FDA, and GxP requirements.
- Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.
Employment Type: Full Time, Permanent
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What MMS Holdings employees are saying about work life
based on 11 employees
Flexible timing
Monday to Friday
No travel
Day Shift
MMS Holdings Benefits
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