Quality Systems Document Control Change Analyst III
Posted on: June 12, 2021
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
- Participate in global Change Management Team meetings to
continuously review, improve and evolve change management systems
- 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
- 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
- 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
- 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
- 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
Education and Experience (in years):
- High School Degree (or equivalent experience) - 4 - 6 years
- Associates or Technical Trade Degree - 2 - 4 years related
Knowledge and skills:
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.
Keywords: Danaher, Sunnyvale , Quality Systems Document Control Change Analyst III, Other , Sunnyvale, California
Didn't find what you're looking for? Search again!