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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary
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.
Primary 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.
- Training (as assigned):
- 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.
Knowledge, Skills, & Abilities
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
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
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Third Party Agency And Recruiter Notice
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
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