Quality Associate I

About This Role

This Quality Associate I role provides daily quality oversight of manufacturing, warehousing, and qualification activities to ensure adherence to cGMP, SOPs, and regulatory standards within a global injectables company.

Responsibilities

• Provide daily quality oversight during manufacturing, warehousing, and qualification activities
• Ensure adherence to cGMP, SOPs, and regulatory standards
• Lead and execute QA review of batch records, logbooks, and related GMP documentation for product disposition
• Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms)
• Ensure proper execution of Good Documentation Practices (GDP) and data integrity in manufacturing records
• Prepare the site for regulatory inspections
• Act as a QA representative during regulatory inspections, internal audits, and customer audits
• Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements

Requirements

• 5+ years of experience in pharmaceutical manufacturing or QA
• Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments
• Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches
• Experience supporting regulatory inspections and validation documentation reviews
• Strong knowledge of 21 CFR part 10 and 211
• Strong knowledge of aseptic GMP manufacturing and QA shopfloor support
• Excellent organizational and communication skills with high attention to detail
• Commitment to data integrity, continuous improvement, and patient safety

Qualifications

• Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)
• 5+ years of experience in pharmaceutical manufacturing or QA

Skills

* Required skills