Quality Assurance in Process

In-Process Quality Assurance Specialist (Sterile Products)

Responsibilities:

Performed in-process quality assurance activities for sterile pharmaceutical manufacturing operations in accordance with cGMP guidelines and regulatory requirements from the U.S. Food and Drug Administration . Conducted line clearance before and after manufacturing operations to ensure proper equipment status, material segregation, and compliance with approved procedures. Performed in-process sampling of sterile products during manufacturing to verify product quality and compliance with approved specifications. Reviewed and prepared Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure completeness, accuracy, and adherence to standard operating procedures. Participated in batch record review and batch release activities , ensuring all manufacturing and quality documentation met regulatory and internal quality standards. Assisted in the review of Annual Product Quality Review (APQR) reports by compiling manufacturing data, deviations, and trend analysis. Verified adherence to Good Manufacturing Practices (GMP) and supported quality compliance during production operations. Investigated deviations, documented observations, and collaborated with production and quality teams to implement corrective actions. Ensured manufacturing and documentation activities complied with quality standards such as those from the International Organization for Standardization and pharmaceutical regulatory guidelines. Coordinated with Quality Control, Production, and Regulatory teams to maintain product quality and ensure successful batch release. #PRO123

Pay:

$58,000.00 - $69,000.00 per year

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person