The QA Sr Specialist, Quality Systems role is the primary person responsible for supporting day-to-day operations of the quality system, including facilitating the management of deviation, CAPA, change controls, lab investigations and other quality records. This role is responsible for partnering with internal customers to improve both systems and processes related to quality records. They will also support other Quality Management System initiatives as opportunities arise. The QA Sr Specialist reports to the Senior Manager of Quality Systems in supporting all activities related to Quality Management Systems.

Required Skills

Under the guidance of the Senior Manager of Quality Systems, the candidate will:

• Support daily maintenance and visibility for the Deviation & Investigation, CAPA, Change Control programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to:

• Maintaining and supporting Quality Systems processes and systems.

  • Ensure quality records are complete, accurate and fully defendable in an inspection
  • Effectively communicate and follow up on quality records with owners/functions
  • Facilitate and communicate metrics cross-functionally to drive accountability
  • Maintain archive database for accuracy of quality record details and location.
  • Support efforts during regulatory inspections, including 3rd party inspections at vendor sites.
  • Retrieval of historical quality records, where applicable
  • Support and provide guidance on risk-based management of quality records.
  • Train, support and advise end users on Veeva QMS processes and workflows.

• Administer and support the Veeva QMS system, providing excellent customer service to internal customers through the management of user access, assignment of user roles, end-user support and training, as well as manage IT support tickets related to the system.

• Provide subject matter expertise to assure deviations, CAPA and change control records meet regulatory requirements and industry practices.

• Take a lead role in quality and process improvement initiatives and project teams.

• Identify opportunities for process and system improvement and implement enhancements.

• Prepare and analyze metrics for management review and escalation of issues.

• Trouble-shoot issues received from end users, support and follow up with users based on established processes, procedures, and guidelines, and escalate to management as appropriate.

Required Experience

Basic Qualifications:

• Bachelor’s Degree in scientific discipline
• 5+ years of quality assurance experience

Preferred Qualifications: 

• Proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments.
• Comprehensive knowledge of good documentation practices
• Knowledge of quality assurance principals, best practices, and quality systems
• Demonstrated ability to coordinate process improvement initiatives and quality system related projects.
• Knowledge of both domestic and international cGMP, GCP and other relevant regulations.
• Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors and consultants.
• Admin experience with Veeva QMS a plus

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

Akebia is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Under the guidance of the Senior Manager of Quality Systems, the candidate will:

• Support daily maintenance and visibility for the Deviation & Investigation, CAPA, Change Control programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to:

• Maintaining and supporting Quality Systems processes and systems.

  • Ensure quality records are complete, accurate and fully defendable in an inspection
  • Effectively communicate and follow up on quality records with owners/functions
  • Facilitate and communicate metrics cross-functionally to drive accountability
  • Maintain archive database for accuracy of quality record details and location.
  • Support efforts during regulatory inspections, including 3rd party inspections at vendor sites.
  • Retrieval of historical quality records, where applicable
  • Support and provide guidance on risk-based management of quality records.
  • Train, support and advise end users on Veeva QMS processes and workflows.

• Administer and support the Veeva QMS system, providing excellent customer service to internal customers through the management of user access, assignment of user roles, end-user support and training, as well as manage IT support tickets related to the system.

• Provide subject matter expertise to assure deviations, CAPA and change control records meet regulatory requirements and industry practices.

• Take a lead role in quality and process improvement initiatives and project teams.

• Identify opportunities for process and system improvement and implement enhancements.

• Prepare and analyze metrics for management review and escalation of issues.

• Trouble-shoot issues received from end users, support and follow up with users based on established processes, procedures, and guidelines, and escalate to management as appropriate.