Quality Assurance Specialist
North Chicago, IL
- Review/approve batch record packets and associated documentation.
- Provide quality approvals in materials management system as defined by procedures.
- Write/review/approve exception documents and corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
- Actively participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues and take preventive actions.
- Participate with support groups in developing/prioritizing QA activity timelines.
Minimum Experience Required:
- 3+ years experience in pharma industry.
- 2 years experience in Quality Assurance or related field.
- Preferred healthcare industry and specific experience in quality function.
- General understanding of US and international regulations for quality systems and compliance.
- Experience in coordination and planning of activities.
- Ability to identify and resolve quality issues through effective use of technical and interpersonal skills.
- BS degree or 3-7 years equivalent experience.
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