Contractor - Sr. Quality Associate

Responsibilities

• The Quality Associate support will initially provide approximately 20 hours per week of support across the following key areas
• Document Creation and Execution Support
• Preparation, formatting, and maintenance of QA documentation within Veeva
• Coordination of document lifecycle activities including review and version control
• Ensuring adherence to internal documentation standards
• Complaints Management Support
• Initiating and tracking of customer complaints
• Supporting data entry, documentation, and follow-up activities
• Assisting in maintaining audit-ready complaint records
• CMO Scorecard Development
• Supporting data collection and consolidation for CMO performance metrics
• Assisting in the preparation and formatting of scorecards and reports
• Maintaining consistency and accuracy in reporting outputs
• Distribution and Quality Disposition Support
• Coordinating distribution of quality-related documents and communications e.g. disposition returns
• Supporting quality disposition processes and maintaining executed record logs e.g Temperature excursions
• Facilitating communication between internal and external stakeholders as needed
• Bona Fide Customer Checks
• Conducting verification checks on customers
• Maintaining accurate and traceable records of compliance activities
• Supporting QA in meeting regulatory and internal compliance requirements
• General Administrative Support (Ad Hoc)
• Event and meeting organization
• Additional administrative duties as required

Requirements

• Required Qualifications
• Bachelor's degree in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline
• Approximately 5 years of hands-on experience in a life sciences Quality environment (biotech, pharmaceutical, medical device, or regulated healthcare industry)
• Demonstrated experience supporting Quality Assurance (QA) and Quality Management System (QMS) activities
• Strong working knowledge of GxP requirements (e.g., GMP, GDP) and regulated documentation practices
• Proven experience with document creation, formatting, execution, and lifecycle management within an electronic document management system (e.g., Veeva Vault or similar)
• Experience supporting complaints management processes, including documentation, tracking, and maintenance of audit-ready records
• High attention to detail with the ability to maintain accurate, compliant, and traceable records
• Strong organizational and time management skills, with the ability to manage multiple tasks and prioritize effectively in a part-time (approximately 20 hours/week) support role
• Excellent written and verbal communication skills, with the ability to interact professionally with internal and external stakeholders
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), particularly for data consolidation, tracking, and reporting
• #LI-HYBRID
• Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
• 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 a

Benefits

Additional Information

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. Job purpose The role will provide structured assistance across document management, complaints handling, reporting, and general administrative activities. Securing this support will improve operational efficiency, strengthen compliance, and enable QA professionals to focus on high-value quality and oversight responsibilities. The Quality Department operates in a highly regulated environment with increasing demands related to documentation, customer assurance, and quality reporting. QA administrative workload has grown significantly, particularly in areas such as complaints management, CMO scorecard development, and compliance checks.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at cytokinetics? Share your experience