Sr. Clinical QA Systems and Documentation Specialist

GRIFOLS, S.A.

4d•Onsite

About The Position

Responsible for the life cycle management of R&D and Clinical documents according to company SOPs. Participate in the implementation of new systems or improvements to existing systems. Administer the clinical trial documentation system in compliance with regulations and procedures so that documents are retrievable in a timely and efficient manner. Responsible for maintaining and developing training profiles and documentation for Clinical departments.

Requirements

Bachelor' s degree in scientific or related field.
Typically requires minimum of 6 years of relevant experience with document systems within a Quality Organization or related area in the Biologics, Biotech or Pharmaceutical industry
Excellent Knowledge and understanding of quality and regulatory requirements for the biotechnology and pharmaceutical industry. Good familiarity with quality systems and compliant maintenance of quality-related documentation and records, including knowledge of electronic document control systems. Proficient in word processing and spreadsheet applications. Proven ability to prioritize competing tasks and meet deadlines to ensure compliance. Excellent oral and written communications skills and the ability to work in a cross-functional and multi-cultural team environment

Responsibilities

Manage the quality document life cycle process to ensure compliance with company procedures and to meet R&D and Clinical objectives
Maintain key department databases and documentation to meet company and regulatory requirements.
Lead new system or process improvement projects, as assigned, to facilitate effective and compliant change (Level 2).
Process change control requests for Clinical and R&D SOPs. Work with Clinical and R&D departments to assist them in developing compliant documents.
Serve as an expert user and provide support to R&D and Clinical staff on the use of the specific documentation systems.
Assist with the collection, organization, tracking, filling archiving and retrieval of clinical documents according to regulations and procedures.
Performs quality control checks of the TMF and collaborates with clinical department to provide copies of TMF and assist the clinical team in resolving any documentation discrepancies.
Maintain information/documents related to training within Clinical and Clinical QA departments, including training matrices.
Monitor and report status of training requirement completions.
Liaise with Performance Development in implementing training initiatives.
Develop position-specific training curricula for job functions in the Clinical and Clinical QA departments (Level 2).
Maintain qualification program to standardize assessment of skills and demonstration of tasks across sites (Level 2).
Develop position-specific training curricula for job functions in the Clinical and Clinical QA departments.