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QA Associate/Specialist
3 months ago
Pay Rate: $50-70/hour depending on experience
Summary:We are seeking a highly motivated Quality Assurance Associate/Specialist to be responsible for ensuring compliance with the quality system’s procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. This role is accountable for routine Quality Assurance duties related to the production and disposition of products manufactured and tested.
Responsibilities:
- Provide quality assurance support across functions (Manufacturing, Supply Chain, QC, Process Development, Regulatory Affairs) and externally to assure compliance and strong relationships.
- Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Batch documentation review and ensure resolution of issues to release product.
- Review and approval of Deviations and CAPAs Support Disposition of product for U.S. and other countries.
- Support of New Product Introductions.
- Support quality assessments of internal operations to analyze quality compliance and assess risk.
- Provide QA guidance on product development projects and technical transfer activities
- Support Management Review activities and oversee trending of key quality, product and GMP metrics.
- Support regulatory inspections, internal audits, and external audits from partners.
- Develop QA Standard Operating Procedures to ensure Quality objectives are met
- Reviews routine manufacturing and quality control data for in-process and finished product.
- Develops solutions to more complex problems.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Perform other duties as assigned.
- Bachelor’s Degree and 3+ years of experience.
- Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
- Proficient in cGMP regulations, quality systems and regulatory requirements.
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- Experience with conducting and managing internal and external audits.
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