Senior QA Specialist, Quality Systems

Quality Assurance

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Job Description:

The Senior QA Specialist/QA Specialist, Quality Systems is responsible for the development, management, and continuous improvement of Quality Systems at Akebia Therapeutics as it relates to Document Control and Training to ensure its products and processes are compliant to regulatory, functional area and business partner or customer requirements. Partner with all areas of the business to understand and address their needs/issues. Interface with all areas of the business to elevate potential issues to management and drive continuous improvement efforts. Provide expertise and leadership in implementing and managing a quality system management function for clinical and commercial products.

Essential Functions & Duties

• Support and sometimes facilitate continuous improvement initiatives designed to increase efficiencies for document control and training processes.
• Support regulatory and partner audits.
• Manage process improvements for Document Control.
• Actively influence and participate on Quality initiatives from a document management perspective.
• Support the GxP training strategy for employees by administering and maintaining the overall training program.
• Collaborate with department subject matters experts to ensure training is effective and in compliance with all regulatory and technical requirements.
• Generate and facilitate changes to SOPs, policies, training materials, and other documents to ensure compliance and continuous improvement.
• Maintaining Document Control processes and systems.
• Provide end-user training and support for document management system and related processes.
• Prepare and analyze metrics for management review and escalation of issues.
• Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established QA processes and standards.
• Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality and regulatory standards.
• Helps identify risk and evaluates deficiencies while working with internal department/business units to appropriate remedy them.

Basic Qualifications

• Bachelor's Degree in scientific discipline and 2+ years of quality assurance related experience.

OR

• Minimum 5 years' experience in Pharmaceutical, Biotechnology, or related industry in a quality role with increasing levels of responsibility.
• Ability to work and think independently and critically as part of the compliance evaluation.
• Document control 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
• Extensive knowledge and understanding of global requirements for cGxP and quality systems for clinical and commercial and ability to apply said knowledge to sound quality decisions.
• Robust working knowledge of software solutions for Document Management System (DMS).
• Demonstrated ability to coordinate process improvement initiatives and quality system related projects.
• Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors, and consultants.
• Admin experience with Veeva QualitySuite and ComplianceWire a plus

Compensation

Targeted Base: $96,744 - 119,545*

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com