Danaher Corporation Documentation Specialist in Sunnyvale, California
Essential Duties and Responsibilities:
Manufacturing Documentation Specialist primary responsibilities are the review of assigned manufacturing documentation and driving the subsequent corrections needed, prior to Quality review of each document, and the creation and update of procedures and worksheets for production operators. Documentation includes executed manufacturing batch records and ancillary documentation such as GMP forms used in the production of Beads Reagent Batches.
Demonstrates an understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, as well as additional professional skills of effective communication and listening.
Performs document review independently with minimal direction for the review process, with some manufacturing process knowledge requirement at this level.
Manages simple issues found during the review of documentation, including identification of documentation errors and completeness.
Identifies when a nonconformance has occurred, understands GMP implications and appropriate actions to take without first obtaining feedback from either a Manufacturing Supervisor or Quality Assurance Specialist.
Responsible for escalations to Supervisors of the team for complex issues that arise during review to gain the information required to make the appropriate decision.
Additional duties include updating and maintaining the document review tracker for Beads Reagent Manufacturing and maintain document organization in specified document control area.
Analyzes existing procedures for concurrence with correct department methods and production records relative to company policies and requirements. Specifically documents related to test specifications, technical documents, batch records, standard operating procedures and forms.
Edits and formats incoming requests for new or revised documents (SOPs, forms, jobs aids, technical documents, worksheets, etc.) and assists in tracking each revision through the approval workflow.
Writes procedures with appropriate details that are easily understood and readily usable for consistency in training.
Writes procedures that reflect the most effective systems within company policies and government regulations to reduce misunderstanding and usability.
Works with Manufacturing personnel, and other cross-functional team to gather information as requested for inclusion in their procedure, method, specification, or batch record.
Participates in routine meetings as assigned by supervision and perform other duties as assigned.
- Completes all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree in Science, Communications, or related discipline with at least 2 years of document review and technical writing work experience
Associate degree in Science, Communications, or Certification in Technical Writing, Quality Systems or related discipline with at least 4 years of document review and technical writing work experience will be considered
At least 2 years of experience working in a GMP environment
Knowledge and skills:
Experience with industry leading PLM systems (Agile, Arena, Propel, Windchill)
Experience writing, proofreading and copyediting.
Experience producing and organizing content with a logical flow
Experience meeting multiple deadlines
Excellent verbal and written communication skills in a regulated manufacturing environment
Understanding of general mathematical principles and calculations, at college entry level
Understanding of cGMP and Safety regulations
Experience in DNA diagnostics or other medical devices
Experience with industry leading Manufacturing Execution Systems (Siemens, Rockwell, GE)
Experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003, and FDA regulations
Practitioner Certification with Society for Technical Communication
- Ability to work in an office environment, as well as spending time in a clean room environment
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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) .