Job Title: Clinical Quality Specialist
Job Description: Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, womenÃ¢??s health (obstetrics/gynecology), orthopedics and Oncology. FerringÃ¢??s US operations employ approximately 900 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
Rebiotix, a late-stage biotechnology company part of the Ferring Pharmaceutical Group, is focused on commercializing the worldÃ¢??s first Microbiota Restoration Therapy. By harnessing the power of the human microbiome, Rebiotix aspires to change the way challenging gastrointestinal diseases are treated. Our goal is to improve the lives of patients and reduce the cost of care associated with some of the most debilitating disorders suffered by patients worldwide. We are a passionate team of scientists, engineers and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for todayÃ¢??s medical field, looking for like-minded individuals to add to our growing team.
Summary: The Clinical Quality Specialist is responsible for supporting the control of Clinical Study documents, Clinical Study Training Program, and Clinical metrics.
- Route Clinical documents for review and approval
- Accurately maintain Clinical training trackers:
- Enter employee training/update electronic logs, Identify overdue training, implement training profile updates, schedule training as required.
- File physical training recordsExecuting on action plans to assess and improve quality and compliance.
- Provide support for BIMO audit prep, audit execution and audit responses at sponsor and as needed sites.
- Creates and/or revises SOPS to ensure compliance with current GCPs, federal regulations and guidelines, and industry standards.as agreed upon by Clinical Quality Manager.
- Prepare key quality indicators, metrics and trending reports for review with clinical management.
- Maintain current knowledge of changes to applicable guidance documents and regulations such as ICH-GCP, FDA, etc.
- Participate in the review/training of clinical study teams to updates related to clinical regulations, guidances and standards.
- Participate in study team evaluations of study specific compliance and trends.
- Support the review of study specific documents, templates, plans and protocols to ensure compliance with applicable regulations and requirements.
- BachelorÃ¢??s degree in scientific field.
- Two (2) or more years of direct clinical experience with a Quality Assurance background in an FDA regulated environment.
- Strong knowledge of quality regulations, current industry practices, and strong experience with interpretation and application.
- Experience with FDA audits for a pharmaceutical and/or biologic company.
- In-depth knowledge of GCP/ FDA and ICH regulations. Thorough understanding of clinical research principles and processes.
- Excellent oral and written communication skills, strong problem-solving ability, critical thinking, creativity, initiative, and interpretation skills.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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