Contract - Senior Quality Document Control Specialist

Cytokinetics is a late-stage 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 muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

Cytokinetics is seeking a highly motivated individual to join our team as a Contract – Senior Quality Document Control Specialist. 

Responsibilities

• Perform document management activities in the electronic document management system for controlled documents throughout its lifecycle (e.g. SOPs, Policies, Work Instructions, Forms) 
• Perform formatting and editing of controlled documents 
• Provide guidance to document owners/authors, collaborators, and approvers throughout the document management lifecycle 
• Act as subject matter expert, provide guidance and training on quality management systems including, but not limited to document management and training 
• Collaborate with functional areas to determine training assignments and assign accordingly 
• Generate and analyze metrics for report out to management and cross-functional areas, as requested 
• Revise Quality Systems procedures, as needed 
• Represent Quality Systems on cross-functional teams 
• Support continuous improvement opportunities within Quality Systems 
• Other duties, as assigned by management 

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• Bachelor's degree in a scientific field, with 8+ years' experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area, specifically with strong experience in Quality Systems operation and maintenance 
• Must be highly organized with a strong attention to detail 
• Advanced skills in MS Office Suite, particularly in Word document processing and formatting 
• Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems 
• Ability to work with ambiguity, has a creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple 
• Ability to work in a collaborative team environment is essential, with a customer-focused approach 
• Proven decision maker with the ability to utilize critical thinking to problem-solve 
• Must have proven interpersonal and communication skills 
• Experience writing, reviewing and editing SOPs, as well as other document types

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer