Job Description: Top Skills:
- 2+ years of Document Control & Reporting Experience,
- Veeva experience preferred
- Technical troubleshooting
- Self-motivated, independent, great communication
- Experience working cross-functionally
Position Summary:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
Experience Basic Qualifications:
- Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
- Strong communication and customer service skills.
- Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
- Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
- Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
- Possess project management skills.
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
- Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
The hourly rate for this position is between $35.00 - $38.00 per hour.
Compensation:
Factors that may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate .
Benefits:
Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.