Full-Time Quality Operations Specialist I (Donor Operations)
Job Description
The Quality Operations Specialist I (Donor Operations Focus) is responsible for performing document review and approval, owning and supporting investigations, representing Quality during donor-related events, coordinating activities related to the Donor Program and Hold Program, acting as a designated trainer, contributing to KPIs and metrics, supporting overall systems design and continuous improvement initiatives for Quality Operations and the Donor Program through ownership of change controls and document updates, and planning and coordinating product disposition (as needed).
Responsibilities:
Perform thorough documentation review using working knowledge of quality concepts and internal procedures and controls.
- Review donor-related paperwork for accuracy and completeness
- Work cross-functionally to resolve any documentation errors
- Demonstrate and advise on Good Documentation Practices
Perform disposition of material and product
- Support disposition activities for DHS source material
- Coordinate with internal and external teams to meet timelines
- Create/review Certificate of Analysis, as applicable
Coordinate activities related to the Donor Program and Hold Program
- Determine donor eligibility
- Provide visibility to the Hold Program, communicate status of items, host meetings as needed, facilitate closure of items, and administer system Provide visibility to material hold and reject process, communicate status of items, host meetings as needed, facilitate closure of items, and administer system
Support daily operations
- Monitor donor activities and identify any deviations
- Attend huddles as the Quality representative
- Respond to donor-related events and work with the Donor Program team to resolve
- Perform investigations and partner with Donor Program personnel to complete investigations.
- Own Change Controls and document updates
Support systems design and continuous improvement initiatives for Quality Operations
- Support change implementation and continuous improvement initiatives
- Own change controls and document updates
- Advise on Donor Program change controls and document updates
Act as a designated trainer for the department
Support department metrics
Support other Quality Operations functions as required
Requirements:
- Bachelor’s degree in a scientific field with 4 or more years in a the pharmaceutical and/or biopharmaceutical industry (or related regulated industry), with experience in a Quality role.
- Note: An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience requirements
- Preferred 2 or more years in a Quality role performing material/product review and disposition.
- Knowledge of quality regulations and current industry practices.
- Knowledge of 21CFR 210 & 211 GMP regulations
- Excellent oral and written skills, ability to function effectively in a team, and manage time efficiently, customer focused approach to activities and interactions, ability to build and maintain positive relationships internally and cross-functionally,
- Strong planning and organizational skills, ability to manage and prioritize multiple activities at once with flexibility for changes in work priorities
- Strong independent judgement, decision making and problem-solving skills, completes routine tasks with little or no oversight and requires minimal direction to complete more complex tasks
How to Apply
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