Contractor - Sr. Quality Associate

Overview

Cytokinetics is a specialty cardiovascular biopharmaceutical company with 25+ years of pioneering scientific innovations in muscle biology. This part time role ( 20 hours/week) provides structured assistance across document management, complaints handling, reporting, and general administrative activities to improve operational efficiency and enable QA professionals to focus on high value quality responsibilities.

Responsibilities

• Document Creation and Execution Support
  • Prepare, format, and maintain QA documentation within Veeva.
  • Coordinate document lifecycle activities, including review and version control.
  • Ensure adherence to internal documentation standards.
• Complaints Management Support
  • Initiate and track customer complaints.
  • Support data entry, documentation, and follow up activities.
  • Assist in maintaining audit ready complaint records.
• CMO Scorecard Development
  • Collect and consolidate data for CMO performance metrics.
  • Prepare and format scorecards and reports.
  • Maintain consistency and accuracy of reporting outputs.
• Distribution and Quality Disposition Support
  • Coordinate distribution of quality related documents and communications.
  • Support quality disposition processes and maintain executed record logs.
  • Facilitate communication between internal and external stakeholders.
• Bona Fide Customer Checks
  • Conduct verification checks on customers.
  • Maintain accurate and traceable records of compliance activities.
  • Support QA in meeting regulatory and internal compliance requirements.
• General Administrative Support (Ad Hoc)
  • Organize events and meetings.
  • Perform additional administrative duties as 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 QA and 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).
• Experience supporting complaints management processes, including documentation, tracking, and maintenance of audit ready records.
• High attention to detail and 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 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.

Pay Range

Pay Range: Our employees come from different backgrounds, and we celebrate those differences.

EEO Statement

Cytokinetics is an Equal Opportunity Employer.