Akebia Therapeutics is seeking a Data Reviewer with proven ability to work in a collaborative manner with members of cross-functional teams. The data reviewer will interact across various levels of personnel from individual contributors to QC and QA management. The successful data reviewer will be able to critically review both paper and electronic analytical data and identify data that are (and are not) integral in terms of GDPS and GMPs, 

Required Skills

The Data Reviewer will maintain and improve, where needed, the system that assures the integrity of the data from global sites both internal and external to Akebia quality systems.

This includes the management of Data Integrity SOPs, continuous conduction of reviews of Quality Control Laboratory data (Chemistry and Microbiology) and, execution and / or oversight of the investigation(s) of any data discrepancies in Quality Control Laboratories if found.   

Moreover, the Data Reviewer will provide Quality Assurance oversight to cross-functional systems including:  

• the administration of electronic GMP systems managed by IT;
• the review / closeout of any approved, aborted or rejected batch record(s); 
• the review / closeout of any non-commercial (Exhibit, Developmental or Engineering, etc.) batch record(s); 
• the review / closeout of records of release and stability reports; 
• the review / closeout of data supporting annual product reviews; 
• review and approval of method validation/verification and transfer protocols and related final summary reports/data; 
• the review / closeout of process validation/verification protocols and related final summary reports/data; 
• the review / closeout of validation qualification and requalification protocols and related final summary reports/data, and;  
• the data reviewer will evaluate data supporting regulatory filings such as NDA and Annual Report filings and provide management to Commercial and Clinical programs as needed.

In addition, the Data Reviewer will perform pre and post review/approval of Quality Assurance systems such as change controls and associated CAPA plans/validation activities. The data reviewer will assist in hosting Internal, customer, and Regulatory Agency audits and track potential responses to audit observations and deficiencies. The Data Reviewer may conduct routine Data Integrity related training and provide.  

Required Experience

BASIC QUALIFICATIONS: 

• Bachelor's Degree 
• Minimum five (5) years of experience working in the pharmaceutical industry
• Experience in a GMP-based laboratory setting

PREFERRED QUALIFICATIONS:  

• Bachelor's Degree in a science related field (g.chemistry, biology, microbiology) 
• Must have a working knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211)
• Ability to work independently in an efficient and detail-oriented manner. 
• Ability to apply analytical reasoning to understand complex issues. 
• Ability to receive instructions and follow rules and policies. 
• Ability to meet deadlines. 
• Ability to maintain confidentiality of work assignments and personnel issues.
• Experience in validation (analytical method or process) is preferred 
• Knowledge with regulatory agency guidances besides FDA regulations and guidance's. 
• Ability to write, review and apply technical scientific writing, procedures and quality policies.

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with 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. 

The Data Reviewer will maintain and improve, where needed, the system that assures the integrity of the data from global sites both internal and external to Akebia quality systems.

This includes the management of Data Integrity SOPs, continuous conduction of reviews of Quality Control Laboratory data (Chemistry and Microbiology) and, execution and / or oversight of the investigation(s) of any data discrepancies in Quality Control Laboratories if found.   

Moreover, the Data Reviewer will provide Quality Assurance oversight to cross-functional systems including:  

• the administration of electronic GMP systems managed by IT;
• the review / closeout of any approved, aborted or rejected batch record(s); 
• the review / closeout of any non-commercial (Exhibit, Developmental or Engineering, etc.) batch record(s); 
• the review / closeout of records of release and stability reports; 
• the review / closeout of data supporting annual product reviews; 
• review and approval of method validation/verification and transfer protocols and related final summary reports/data; 
• the review / closeout of process validation/verification protocols and related final summary reports/data; 
• the review / closeout of validation qualification and requalification protocols and related final summary reports/data, and;  
• the data reviewer will evaluate data supporting regulatory filings such as NDA and Annual Report filings and provide management to Commercial and Clinical programs as needed.

In addition, the Data Reviewer will perform pre and post review/approval of Quality Assurance systems such as change controls and associated CAPA plans/validation activities. The data reviewer will assist in hosting Internal, customer, and Regulatory Agency audits and track potential responses to audit observations and deficiencies. The Data Reviewer may conduct routine Data Integrity related training and provide.