Furniture Sales Professional - Ashley Homestore - Chicopee MA Full Time
The QA Specialist, Documentation and Training role is the primary person responsible for day-to-day operations of the document control and training programs, including the document revision process, record archival, and training activities within the electronic Quality Management System. They will also support other Quality Management System initiatives as opportunities arise. The QA 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:
Coordinate and maintain the Documentation and Training 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 Document Control processes and systems.
Support the GxP Training Program
Participate in quality and process improvement initiatives and project teams.
Identify opportunities for process and system improvement and enhancement.
Prepare and analyze metrics for management review and escalation of issues.
Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to management as appropriate.
Required Experience
Basic Qualifications:
Preferred Qualifications:
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 Therapeutics 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:
Coordinate and maintain the Documentation and Training 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 Document Control processes and systems.
Support the GxP Training Program
Participate in quality and process improvement initiatives and project teams.
Identify opportunities for process and system improvement and enhancement.
Prepare and analyze metrics for management review and escalation of issues.
Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to management as appropriate.