- Location: Bothell, Washington (On Site)
- Employment Type: Contract (6-month W2 contract with potential for extension or transition to perm)
- Pay Rate: $50-56/hour (Depending on Education and Experience)
- Issuing production batch records, labels, and other controlled documents for manufacturing operations
- Organizing cGXP controlled document files within the Document Center
- Managing electronic document systems for the JuMP site
- Writing and revising document control procedures
- Supporting internal and external audits and regulatory inspections
- Performing Document Control metric reporting and analysis
- Strong communication and customer service skills
- Technical writing skills
- Proficiency in MS Office and Quality Systems
- Ability to prioritize, multitask, and troubleshoot effectively
- Experience with FDA or other regulatory agencies preferred
- Knowledge of cGMPs and domestic regulatory requirements
- Project management skills
- Innovative, proactive, and resourceful
- Committed to quality and continuous improvement
- Ability to collaborate effectively and work well under pressure
- Independent decision-making and problem-solving abilities
QA Document and Labeling Specialist - Mill Creek, United States - Yoh
Description
QA Document and Labeling Specialist
Summary:
We are looking for a detail-oriented QA Document and Labeling Specialist to join our team. This role involves supporting cGMP Document Control operations, including handling document change control processes, issuing batch records, managing product labels, and ensuring proper archival and retention of GMP records.
Responsibilities:
Skills or Requirements:
Must demonstrate the following behaviors consistently: