Clinical QA Systems and Documentation Specialist

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 for role

• 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.
• 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.

Knowledge, Skills, & Abilities:

Good Knowledge and understanding of quality and regulatory requirements for the biotechnology and pharmaceutical industry. 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. 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 5 years of 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.