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- Grafton, WI 53024
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Quality Assurance Associate
AMRI • Grafton, WI
Posted 1 month ago
QUALITY ASSURANCE ASSOCIATE in Grafton, WI
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Quality Assurance Associate is an integral part of the AMRI team, contributing to our success by assuring that all documentation, procedures and protocols comply with GMP and FDA guidelines.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
In this role, you will:
• Conduct batch record and test data reviews, and approve batches for release
• Assist in maintaining compliance of Environmental Monitoring, Equipment Calibration, and the Equipment Maintenance Program
• Issue Deviation, CAPA, and OOS investigations. Track investigations and outcome. Review and recommend approval of indicated actions to senior associates or quality management
• Conducts audits of all areas of AMRI Grafton, and assists with writing audit reports.
• Write and review Annual Product Review reports.
• Write protocols for Process Validation Protocols and assist with writing of Process Validation Reports
Qualifications and background to be successful in this role:
• B.S. degree in Chemistry or related field and 1- 3 years’ experience in pharmaceutical manufacturing or 4-6 years of equivalent experience.
• Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, Quality System SOPs, and current compliance standards, including data integrity requirements.
• Ability to audit documents, procedures, and records for accuracy and continuity
• Strong written and verbal communication skills.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.
Shift: First Shift