Target PR Range:

33-43/hr

DOE JOB DESCRIPTION SUMMARY/JOB PURPOSE

The R D Quality Specialist is responsible for providing support to the planning and reporting of GCP/GVP audit activities, including audit preparation, audit closure, audit observation tracking, and records management. As part of continuous improvement initiatives, they will assist in the administration and timely entry of audit reports and related information into the Veeva Quality Vault application. In addition, they will be responsible for ensuring data is migrated to the Veeva audit module.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for maintaining audit-related records throughout the program lifecycle.
• Responsible for obtaining and compiling data relevant documents and data in preparation for the conduct of audits
• Assist in maintaining and developing standardized templates based on regulatory requirements and procedures.
• Conduct follow-up activities with internal stakeholders related to the RDQA audit program.
• Input and maintain audit reports in the Veeva Audit Module.
• Assist in tracking and trending of quality metrics related to the RDQA audit program.

SUPERVISORY RESPONSIBILITIES

• No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

Education:

• BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 4 years of related experience in biotech, pharmaceutical, or related industry.
• Also would consider no formal degree with a minimum of 6 years of related experience in biotech, pharmaceutical, or related industry.

Experience:

• Minimum of 4 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
• Must have high attention to detail and excellent organizational skills.
• This position requires a basic knowledge and experience with GCP and / or GVP processes related to the conduct of audits.
• Administrative experience in organizing and maintaining audit related records.
• Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
• Keeps Management informed of status of assigned projects.

Knowledge/Skills:

• Strong written and oral communication skills.
• Excellent attention to detail and organizational skills.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Strong user of Microsoft Office applications.

WORKING CONDITIONS

Facilities/Alameda with consideration for remote

Environment:

primarily working in an office setting

• Essential physical requirements; sitting, standing, and typing.
• Physical effort/lifting; light - up to 20 pounds
• CO/NYC candidates might not be considered