Danaher Corporation Quality Systems Document Control Change Analyst III in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES:
CHANGE CONTROL (50% allocation minimum)
Perform detailed change analyst review and quality assessment of Development, Validation and Production electronic Change Orders associated with controlled documentation and part item revisions and releases prior to routing for cross-functional review and approval within the organization. Ensure Change Order descriptions, content, fields, attributes, file attachments, product structures, lifecycle and revision configurations and workflows conform and comply with corporate quality, regulatory and risk management procedures, cGMP and designated review and approval requirements.
Participate in global Change Management Team meetings to continuously review, improve and evolve change management systems and processes.
Administer assigned Agile PLM System functions related to the maintenance of user profiles and roles
- Review records and documents for completeness and compliance with QSR, ISO and internal template and procedure requirements. Perform final incorporation of documentation revisions and pre-release preparation of the document files associated with approved change orders and ensure workflow activities are completed.
- Provide prompt responses, task fulfillment, solutions and answers to a wide variety of requests related to document control and change process activities received within an electronic Work Ticket system and via email and telephone from a rapidly increasing and diverse group of associates employed locally and worldwide.
Participate and assume a rotational responsibility to lead local Document Control Department meetings.
Provide feedback and continuous improvement suggestions and ideas as an individual contributor, group member or in team activities such as Kaizen events. Apply an analytical approach to resolving topical issues, minimizing or eliminating non-value adding activities. Complete required deliverables to ensure potential problems, errors or non-conformances are detected and resolved quickly and thoroughly to support quality goals and initiatives and achieve interdepartmental customer satisfaction.
Assist Document Control Department Supervisor and Manager with coordination, tracking and execution of project activities.
Create or update standard operating procedures and work instructions as an individual contributor and in concert with orchestrated team projects.
Develop training materials within an electronic Learning Management System.
Assist with developing user experience surveys and conduct Instructor Led training sessions.
Provide back-room support and SME representation of Document Control, Records Management and Change Control processes during internal and third-party audit activities.
Provide data and manage reporting to support department metrics, analytics and reporting.
- Complete all assigned and required training satisfactorily and on time.
Education and Experience (in years):
High School Degree (or equivalent experience) – 4 - 6 years related experience.
Associates or Technical Trade Degree – 2 - 4 years related experience.
Knowledge and skills:
Demonstrated solid understanding of Quality System Regulations (21 CFR Part 820, FDA cGMP) and ISO requirements (13485-2016).
Excellent verbal and written communication skills in group or one-on-one settings.
Thorough familiarity with at least one PLM System (Oracle/Agile or Oracle Cloud preferred).
Microsoft Office Suite (Word, Excel, Powerpoint) at minimum intermediate level.
Experience editing and converting files to Adobe Acrobat .pdf format.
Understanding of Sharepoints, remote conferencing applications, etc.
Ability to interface well with people of varied backgrounds and to guide groups toward effective dynamics.
Experience in compiling data to support metrics reporting and analyzing current processes.
Must be able to lift 25 lbs. Must be able to stand and/or sit for several hours. Work may involve repetitive arm/wrist motions.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .