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Transportation Quality Assurance Specialist
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Quality Assurance Specialist
2 months ago
Position Overview:
Laboratory work involving biological samples. Key Responsibilities: Ensures quality presence on the production floor; assesses in-process materials and final products. Investigates and rectifies Good Documentation Practice (GDP) discrepancies. Conducts reviews of batch records. Guarantees that manufactured products adhere to all relevant regulations and standards. May assist in preparations for regulatory and client audits. Performs both standard and more intricate reviews and approvals of manufacturing formulation batch production records to support product release in line with specifications and Standard Operating Procedures (SOPs). Inspects and approves intermediates or packaged pharmaceutical products according to specifications. Monitors various processing stages alongside the necessary documentation to ensure compliance with specifications. Drafts and evaluates specifications and SOPs. Tracks and analyzes batch record discrepancies, providing Quality Assurance management with quality indicator data. May offer guidance to junior staff members. Provides comprehensive support during routine inspections of Good Manufacturing Practice (GMP) areas. Required Qualifications: Bachelor’s degree in Biology, Chemistry, or a related field, or equivalent experience is preferred; a scientific degree is advantageous. Minimum of 2 years of relevant experience in a regulated environment, with at least 2 years concentrated on product quality. Familiarity with biotech product manufacturing processes. Understanding of US and EU current Good Manufacturing Practices (cGMP) regulations and guidelines. Knowledge of Oracle, BMRAM, MES, and Veeva Infinity is a plus. Experience in documentation review. Background in working within a GMP environment. Compensation: $35.70 per hour.Eclaro Benefits: Retirement Savings Plan managed by Merrill Lynch Pretax Commuter Benefits Eligibility for Medical, Dental & Vision Insurance through Eclaro
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