Contract - QA Document Control Specialist

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.
Responsibilities

• 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.

Qualifications

• 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.

Pay Range:

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.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer