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Collaborate with Facilities, SMEs and stakeholders to write, create, and update detailed operational procedures, forms, manuals, instructions, and other documents for Facilities.
Use Product Lifecycle Management software to complete tasks, drive closure of document improvements, and engineering change orders on behalf of the Facilities department
Organize materials and complete writing assignments according to set standards regarding order, clarity, conciseness, style, and terminology.
Collaborate within and across departments to collect and interpret input to be incorporated into documents.
Collaborate with change management to continuously improve/maintain documentation to support business needs.
Provides recommendations for business process improvements as they are identified during daily activities.
Provides management with status updates on assigned responsibilities and escalates issues with respect to these responsibilities and goals in a timely fashion.
Supports department initiatives/projects by aiding in capturing activities through documentation.
Collaborate with departments to ensure compliance activities are executed efficiently and effectively, and in accordance with all governing documents and external guidelines.
Interacts constructively with employees, managers and cross-functional peers.
Interface with vendors to deliver new documentation and potential review/training meeting our quality requirements.
Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.
Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.
Support in global document alignment and restructuring initiative.
Maintains awareness of standards that regulate our industry (ISO 13485, 21 CFR 820, etc).
Supporting internal audits of Facilities operations
Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management.
Ensures compliant documentation related to area of responsibility.
Aid in the Implementation of an action plan related to gaps in existing documents and/or missing documents (tier II and tier III documents)
Support in CAPA management related to proper documentation and content within procedures, policies, instructions, validations, etc.
Expanded responsibilities could entail validation/qualification document generation, system improvement for documentation retention, and supporting the initiative of electronic documentation and processes.
Experience in a cGMP environment and the ability to make sound cGMP decisions
Ability to interpret and relate quality standards (ISO 13485, 21 CFR 820, etc) for implementation and review.
Ability to communicate clearly and professionally both in writing and verbally.
Flexibility in problem solving, providing direction and work hours to meet business objectives.
Ability to work independently and cross-functionally in a dynamic environment.
Strong time management and prioritization skills to manage multiple projects with critical deadlines in a fast-paced environment.
Must have experience working as a technical writer preferably in a Quality, Facilities Compliance, Validation, Operations, or Engineering role. A broad understanding of Facilities-related subject matters is preferred.
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