QA Data Specialist

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 Summary:

The QA Data Specialist is responsible for support of GMP compliance with a focus on QC/analytical data through provision of critical review, organization, and Quality oversight of records generated during GMP release and stability testing of clinical and commercial products produced at Akebia's contract manufacturing organizations (CMOs). This individual works within a cross functional team. Role may require some travel both domestic and international.

Essential Functions & Duties

• Review of analytical records generated during the testing of Active Pharmaceutical Ingredient (API) and drug product for compliance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Records include, but are not limited to lot release, stability and raw material test records.
• Input of analytical data into LIMs or a designated repository for storage and trending purposes.
• Generation and ownership of change controls and associate change actions as they pertain to analytical methods and analytical specifications for Akebia API and drug product.
• Provide Quality Assurance (QA) review and input for QC/analytical SOPs, test methods, and protocols.
• Provide review and input for generation of new or revised QA SOPs and other controlled documentation. Author quality documents as assigned.
• Train and maintain proficiency in using electronic Quality Systems for managing change control, and CAPA.
• Upload vendor documentation (validation protocols, reports, etc,) into electronic quality systems.
• Initiate quality events in electronic quality systems.
• Communicate effectively with team members and other departments to assess daily needs and priorities.
• Escalate issues and concerns to appropriate Quality Management to ensure timely resolution and maintain project momentum.
• Appropriately manage and oversee Akebia's Quality Management System it relates to analytical data and data integrity.
• Assist with Quality project needs as required
• Other duties as assigned.

Basic Qualifications:

• Bachelor's degree
• Minimum 4 years of Quality Assurance, Quality Control and/or Stability experience in a GMP regulated environment in the biotech or pharmaceutical industry.
• Experience in authoring, revising, and reviewing Change Controls
• Experience reviewing QC analytical data

Preferred Qualifications

• Bachelor's degree in a Scientific Discipline
• Familiarity with analytical methodologies such as HPLC, GC, UV, dissolution, Karl Fischer
• Experience working with external partners (e.g. CMOs, contract laboratories and suppliers)
• Ability to work cross-functionally in a fast-paced matrix organization
• Ability to work independently with minimal direction
• Excellent communication skills
• Strong project management skills

Compensation

Targeted Base: $98,921 - $122,196

*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

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 characteristics protected by applicable law.