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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.
Responsibilities:
• 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.
Position Requirements:
• Knowledge of medical device regulations and standards such as ISO 9001:2008, 21 CFR820 and ISO 13485.
• A thorough understanding in use of PLM, ERP, LMS applications (i.e., Agile, SAP, Compliance Wire).
• Direct hands on experience with processing Change Orders using Agile PLM.
• Ability to design and develop written instructional materials, procedures, and guidelines of the highest quality.
• Strong background in revising, reviewing, and processing discrete and process BOMs and drawings (i.e., schematics, PCB, Software, etc.).
• Strong skills in creating and maintaining required Document Control departmental metrics.
• Demonstrated ability to follow instructions/schedules/timelines and handle multiple priorities in a dynamic environment.
• Demonstrated ability to train, provide feedback and re-train employees.
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
• Strong working knowledge of Adobe Acrobat, and MS Office - especially Word, Excel, and Visio.
• Ability to work in a high volume fast paced environment with minimal instruction on routine work, and general instructions on new assignments.
• Ability to implement departmental process improvement recommendations that will support the strategic business goals of the company.
• Excellent interpersonal and communication skills combined with a sincere passion for enabling others through training.
• Must be a self-starter with a strong focus on quality, and exercises good judgment within broadly defined practices and policies in selecting methods, techniques and criteria for obtaining results.
• 3-5 years demonstrated experience and expertise in Document Control coupled along with hands on experience in administering a training database in a GMP/ Medical Device industry.
• BA degree preferred
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
To Apply:
Responsibilities:
• 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.
Position Requirements:
• Knowledge of medical device regulations and standards such as ISO 9001:2008, 21 CFR820 and ISO 13485.
• A thorough understanding in use of PLM, ERP, LMS applications (i.e., Agile, SAP, Compliance Wire).
• Direct hands on experience with processing Change Orders using Agile PLM.
• Ability to design and develop written instructional materials, procedures, and guidelines of the highest quality.
• Strong background in revising, reviewing, and processing discrete and process BOMs and drawings (i.e., schematics, PCB, Software, etc.).
• Strong skills in creating and maintaining required Document Control departmental metrics.
• Demonstrated ability to follow instructions/schedules/timelines and handle multiple priorities in a dynamic environment.
• Demonstrated ability to train, provide feedback and re-train employees.
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
• Strong working knowledge of Adobe Acrobat, and MS Office - especially Word, Excel, and Visio.
• Ability to work in a high volume fast paced environment with minimal instruction on routine work, and general instructions on new assignments.
• Ability to implement departmental process improvement recommendations that will support the strategic business goals of the company.
• Excellent interpersonal and communication skills combined with a sincere passion for enabling others through training.
• Must be a self-starter with a strong focus on quality, and exercises good judgment within broadly defined practices and policies in selecting methods, techniques and criteria for obtaining results.
• 3-5 years demonstrated experience and expertise in Document Control coupled along with hands on experience in administering a training database in a GMP/ Medical Device industry.
• BA degree preferred
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
To Apply:
