This position will serve as a Specialist for the Document Control and Training functions will be responsible for control and maintenance of all relevant quality system documentation. In addition, the Specialist will be responsible for assisting with and maintaining training in compliance with all applicable regulations and standards.
- Support the development, implementation and maintenance of the corporate document control and training processes and systems.
- Review all documents submitted and assess compliance to document control and / or training processes.
- Process documents and / or training through the applicable process using Agile, SharePoint and / or Oracle.
- Monitor and control incoming and outgoing changes to assure requirements are met and processed in a timely manner.
- Collaborate with functional management to develop training curriculum linked to job roles.
- Provide reports to management on document control and training compliance, status and gaps as needed.
- Support systems to assure records are complete and archived according to applicable record retention processes.
- Bachelor's degree in an engineering, scientific, educational or related field
- Minimum of 3 years pharmaceutical and/or medical device industry experience is required with a focus on document control and / or training
- Experience with Agile, SharePoint and / or Oracle is preferred
- Strong understanding of cGMP, FDA regulations such as 21CFR820 and ISO series of quality standards such as ISO 13485 is required.
- Excellent written and verbal communication skills
- Excellent organization and interpersonal skills
- Strong interpersonal skills, including persuasion, effective communication, objectivity, assertiveness, and thoroughness.
- Ability to travel up to 10% of the time