Quality Assurance Regulatory Specialist

2 weeks ago


Foster City, California, United States R&D Partners Full time

A leading biotechnology organization is seeking a Regulatory Affairs Specialist (CMC) to enhance the Data Administration team. This position offers a hybrid work arrangement.

Key Responsibilities

  • Conduct data entry utilizing internal systems to accurately input and maintain essential product details for cross-departmental collaboration.
  • Collaborate effectively with the Regulatory Affairs CMC team to achieve project milestones and deadlines through diligent data entry and quality assurance of the information processed.
  • Ensure the accuracy, completeness, and uniformity of data and its structural organization.
  • Support project initiatives aimed at improving information systems for Regulatory Affairs CMC and the stakeholders who depend on this data.
  • Develop and acquire necessary system expertise and knowledge, with training provided by management and colleagues.
  • Work under the guidance of senior Regulatory Affairs CMC Systems professionals.

Required Qualifications

  • Familiarity with data entry processes in intricate information systems is essential.
  • Experience with web-based Electronic Data Capture (EDC) and data management platforms is preferred.
  • Proficiency with Veeva Vaults is required, with experience in RIM Vault being advantageous.
  • Strong verbal and written communication abilities, along with excellent interpersonal skills.
  • Demonstrated organizational skills and the capacity to manage multiple projects simultaneously under tight deadlines.

Compensation:

  • Salary range: $102,052 - $126,568

Why Consider R&D Partners?

As part of our team, you will benefit from a comprehensive package that includes:

  • Medical insurance options including PPO, HMO & HSA
  • Dental and Vision coverage
  • 401k retirement plan
  • Employee Assistance Program
  • Long-term disability benefits
  • Weekly payroll
  • Expense reimbursement
  • Online timecard management

R&D Partners operates as a global functional service provider and strategic staffing resource, specializing in scientific, clinical research, and engineering roles. We offer diverse job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors.

R&D Partners is committed to equal employment opportunities.



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