Cytokinetics, Incorporated-posted 3 months ago
$56 - $93/Yr
Full-time • Mid Level
South San Francisco, CA
501-1,000 employees
Chemical Manufacturing

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. As a Document Control & Training Specialist, this position will ensure documents submitted to Document Control are formatted according to requirements and processed in the Quality Management System (QMS). They will collaborate with personnel from cross functional groups assisting with management of records throughout the document lifecycle. They will track training and communicate coming due and overdue training, prompting compliance.

  • Manage and process controlled documents in the electronic document management system throughout their lifecycle (e.g. SOPs, Policies, Work Instructions, Forms)
  • Perform formatting and editing of controlled documents to ensure consistency and compliance prior to routing for document approvals.
  • Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle.
  • Track training, prompting employees to complete training on time.
  • Minimum of 5 yrs of experience performing Document Control & Training.
  • Knowledge of Veeva Vault Quality Docs and Training required.
  • Must be highly organized with a strong attention to detail and comfortable working in a fast-paced environment.
  • Must have advanced skills in MS Office Suite, particularly in Word document processing and formatting.
  • Experience writing, reviewing and editing SOPs, as well as other document types.
  • Ability to work in a collaborative team environment is essential, with a customer-focused approach.
  • Must have strong interpersonal and communication skills.
  • Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems preferred.
  • Equal Opportunity Employer
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