Location:
Minnetonka, MN
Schedule:
Standard Office Hours
Duration:
4-Month Initial Contract
Pay range:$30.00 - $33.50/hour
The Quality Systems Coordinator II
supports the administration of quality system events and the maintenance of GxP records. This role ensures smooth progression of quality events through various stages, assisting users in completing transitions promptly and in compliance with requirements.
Key Responsibilities
(may include, but are not limited to)
:
- Administer and oversee quality event processes, ensuring adherence to standards and tracking operational performance.
- Sort, classify, and manage records in accordance with retention schedules, regulatory guidelines, and internal procedures.
- Organize and maintain physical records to ensure they remain accessible and traceable.
- Support the upkeep and distribution of logbooks.
- Assist with issuing manufacturing batch records.
- Support complaint handling teams by entering product complaint data.
- Perform additional duties as assigned.
Qualifications
- High school diploma or equivalent, with at least 4 years of experience in the life sciences or medical device industry.
- Equivalent combinations of education and experience will be considered.
- Background in quality systems coordination and records management.
- Experience with MasterControl preferred.
- Broad exposure to Quality functions.
- Knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and other applicable regulations, standards, and guidance documents.
- Demonstrated integrity, self-confidence, and commitment to prioritizing the safety and well-being of product recipients and customers.
- Strong interpersonal skills and ability to work effectively with internal stakeholders at all levels.
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