External Quality Associate
Job Description
R&D Partners is seeking to hire an External Quality Associate I in Novato, CA.
Your main responsibilities as an External Quality Associate I:
Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in controlled document management system (Veeva).
Initiate and set-up change control workflows for product specification revisions in Veeva and quality management system.
Coordinate Veeva change control workflows for review and approval of product specification revisions.
Monitor and ensure document implementation timelines.
Monitor backlog in associated trackers.
What we are looking for in an External Quality Associate I:
Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.
Strong attention to detail, organization and communication skills.
Ability to maintain organization of a large volume of data in a systematic manner
Proficiency with computer systems (Microsoft Office Suite).
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
Medical insurance PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
{If applicable} Pay Scale:
$72,034 $90,048 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.