Clinical Quality Specialist
Our client, a leading biopharmaceutical company focused on discovering and delivering medical treatment for those living with rare metabolic diseases, is currently searching for a remote Clinical Quality Specialist. As the Quality Event Contractor, Clinical Quality Assurance, you will be responsible for coordinating and ensuring quality activities are documented in compliance with corporate policies and standards, in the TrackWise system with minimal supervisory oversight.
- Coordinate and conduct Corrective Actions post audits and Quality Events filed
- Work with line functions and QA management in the development of GCP, GLP and PV corrective action assessments plans and collecting related documentation.
- Analyze and report trends in audit findings, as requested.
- Review and assess key metrics (i.e., quality of TMF structure, risks, time for project, etc.).
- Assist in the development of training for auditees.
- Act as a QA representative in program and protocol team meetings.
- Maintain knowledge on industry leading practices and current regulations surrounding GCP compliance.
- Participate in regulatory inspection activities for sponsor and sites.
- Other QA-GCP activities as assigned.
- Provide Program Team and Senior Management with regular study updates/status reports on study execution. Act as a liaison between departments within the company for project-related matters.
Skills and Requirements:
- BA/BS degree within a scientific discipline.
- 3+ years in the Pharmaceutical/Biotechnology industry is required with at least 2 years in the GCP or GLP or PV arena.
- Experience in a TrackWise database is required.
- Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP/GLP guidelines.
- Solid written and verbal communication skills, analytical and problem solving skills.
- Flexible, highly motivated, with strong organization skills and the ability to multi task.
- Be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
- Proficient Computer Skills, specifically: MS Word, MS Excel, MS PowerPoint. MS Project proficiency is a plus.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.