Responsible for structuring and populating MFG applications (SAP, AGILE,) with new product information such as part numbers, bill of materials, and other product related information. The new product information will come from various internal customers, including; Operations, Engineering, and Finance. The information will be checked for completeness and integrity, as processed through Document Control’s Change Control process. Will also, be responsible for administering Pac Bio’s corporate Learning Management System (LMS). The candidate should possess the technical aptitude and knowledge to work within these structures, functions, and applications to adequately and efficiently support a high volume Medical Research & Development and Manufacturing environment.
• Will assist in the entry and maintenance of all product documentation, as well as, ensure timely, thorough, and accurate release of Change Orders (CO’s), and Manufacturing Change Orders (MCO’s) processed through Agile and SAP.
• Ensure processes for maintaining controlled quality system and product documentation in electronic format is well defined to meet Pac Bio’s business management system requirements.
• Ensure accuracy and integrity of data is maintained in all Document Control databases (Agile/SAP/LMS).
• Manages the content on the LMS training database providing additional learning opportunities for employees and creating relevant procedures to support process.
• Utilizes the LMS to track learning requirements and continuously communicates to departments regarding their training needs and compliance to those needs.
• Works closely with the Quality department and other functional departments to assign and manage training requirements as it pertains to CO’s.
• Lead and manage Change Control Board (CCB) meetings as applicable.
• Will support Document Control customers in achieving targeted product launch schedules.
• Will provide relevant key performance indicator data as required.
• Ensure processes for maintaining controlled quality system and product documentation in electronic/hard copy format are well defined to meet company business management system requirements (e.g. drawings, procedures, quality system records, bills of materials, specs, technical literature etc.)
• Will assist in performing Agile Product Lifecycle Management (PLM), LMS, and other departmental employee training.
• Will develop and review procedures, and other quality system documentation to ensure adherence to Good Manufacturing Practice (GMP), ISO 13485 requirement, or other related procedures.
• Provide administrative/project support related to documentation system requirements.