Essential Job Functions
Maintain accurate and secure filing systems for compliance documentation to include current active/effective/published documents, inactive documents and obsolete documents inclusive of the historical information in accordance to company SOPs.
Ensure product documentation is maintained according to CGMP, GCP and/or GLP standards and applicable regulations and guidelines.
Maintain the agreed upon Common Technical Document (CTD) format for the preparation of well-structured applications that will be submitted to regulatory authorities.
Support document formatting and editing functions to aid with finalization of internal documents.
Bachelor's degree or equivalent combination of education and experience
Bachelor's degree in engineering, mathematics, computer science, chemistry, physics, biology or related field preferred
Zero or more years of experience in application and/or engineering technology development
Experience working with relevant scientific development and engineering principles and practices
Experience working with company products and offerings
Experience working with the technology industry
Experience working with mathematical, physical, chemical, biological or aerodynamic principles
Minimum of one year of experience in the biologics, pharmaceutical and/or medical device industry as an auditor or equivalent in a quality assurance decision-making capacity.
Demonstrated experience working in regulated systems and documentation
Must possess moderate knowledge of local, state and federal regulations pertaining to GXP, CGMP, GLP and GCP, in addition to Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines
Excellent problem solving skills
Excellent organizational skills to balance and prioritize work
Strong interpersonal skills to interact with customers and team members
Strong writing, editing and word processing skills
Ability to work independently and as part of a team
Ability to handle and follow up on multiple tasks and projects
Ability to perform work on complex projects with minimal supervision
Accurate and detail orientated. Ensure efficient, high quality deliverables