Quality Assurance Associate

Quality Assurance Associate

The Quality Assurance Associate is responsible for ensuring compliance with cGMP standards, SOPs, and regulatory requirements in the manufacturing of solid oral dosage pharmaceutical products. This role supports real-time quality oversight, documentation review, environmental monitoring, and cross-functional collaboration to maintain product quality and compliance.

Key Responsibilities:

• Review and recommend updates to SOPs and batch records
• Provide feedback on proposed SOP revisions to management
• Perform real-time batch record audits for accuracy, completeness, and compliance
• Conduct room and equipment clearance following cleaning procedures
• Perform environmental monitoring, including microbial swabbing of equipment and surfaces
• Ensure adherence to SOPs, cGMP, and CFR guidelines
• Conduct in-process and finished product testing such as:
• Particle size
• Bulk density
• Moisture analysis
• Appearance checks
• AQL testing
• Monitor manufacturing areas for compliance with quality and safety standards
• Identify and help resolve deviations to prevent production impact
• Initiate and document deviation reports in Track Wise with detailed findings
• Manage quality status of WIP and finished goods in JD Edwards and physical inventory
• Support deviation investigations, including data collection and root cause analysis
• Enforce GMP compliance across operations
• Assist with customer complaint investigations
• Provide training and coaching to manufacturing staff as needed
• Support continuous improvement initiatives (CAPAs, training, efficiency projects)
• Collaborate cross-functionally to assess quality impacts and investigations

Qualifications:

Minimum Requirements:

• Bachelor's Degree OR
• Associate's Degree with 1+ year of relevant experience OR
• High School Diploma/GED with 2+ years of relevant experience