QA Manufacturing Specialist I/II (4x10, 1900 - 0530)
KBI Biopharma•Boulder, CO
•$67,000 - $85,000•Onsite
About The Position
The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations.
Requirements
- QA Specialist I: Bachelor’s degree and 2 years of experience
- QA Specialist II: Bachelor's degree and 6 years of experience
- Experience in a cGMP QA environment or equivalent is preferred.
Responsibilities
- Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs
- Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records
- Support Manufacturing changeover process
- Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner
- Author, review, and approve deviation investigations
- Support client batch record review process
- Support QA Raw Material group with release of raw materials as needed
- Able to react to change productively and handle other essential tasks as assigned.
Benefits
- shift differential
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
