Quality Auditor

Do you want to make a difference by saving lives? Want to work for a not-for-profit? Miller-Keystone Blood Center helps to save lives every day by providing blood products to hospitals in NJ and PA. This position is responsible for the planning and performance of internal audits to ensure that processes and procedures at all levels of the organization's operations follow applicable regulatory and accreditation requirements. Work with auditees to perform audit follow-up (i.e. facilitate CAPA process) for both internal and external audits. Prepare summary data for internal and external audits for Senior Management. Responsible for ensuring that all vendors are qualified and annually reviewed in accordance with vendor qualification process. Maintain blood center licenses and certificates.

Qualifications

• Bachelors degree in Science, Healthcare, or related discipline required
• 2 - 5 years' experience auditing in healthcare, medical, blood centers, or pharmaceutical environments required
• CQA / ASQ Certification required, or able to obtain within 18 months of employment
• Ability to work in a regulated environment
• Ability to read technical information and present in a user-friendly language
• Experience in cGMPs specified by FDA guidance documents or related association documents
• Solid analytical skills and the ability to interpret and use data to make sound decisions
• Ability to work collaboratively with a diverse group of employees
• Possesses excellent communication skills, including technical writing, & oral communication
• Experience with Microsoft Office applications (Outlook, Word, Excel, etc.)

Responsibilities:

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  Regulatory Compliance Support enforcing compliance to FDA, AABB, and other standards and regulations through reviews of policy, procedures, SOPs or other documentation

  
  
• Auditing of the internal quality system to ensure effectiveness of the system and compliance to cGMPs and other regulatory requirements
• Track all regulatory licenses and certificates necessary for the collection, processing, and distribution of blood products
• Work with department heads to qualify new vendors and update the Approved Vendor list
• Facilitate process improvement by training staff and facilitating problem definition, root cause analysis, mitigation and prevention action, and effectiveness monitoring
• Responsible for writing, updating, and/or reviewing departmental Standard Operating Procedures

Pay and hours

Monday through Friday 8:00AM-4:30PM

Starting salary at $55,000 based on experience and certification