In-Process Quality Assurance (IPQA) Specialist

About the Role

A growing pharmaceutical manufacturer is seeking an In-Process Quality Assurance (IPQA) Specialist to provide real-time quality oversight across sterile manufacturing operations. This individual will serve as a key quality presence on the manufacturing floor, ensuring compliance with cGMP requirements, approved procedures, batch records, and internal quality standards. This is an excellent opportunity for a quality professional who enjoys being closely involved with manufacturing operations while helping drive compliance, quality culture, and inspection readiness.

Responsibilities

• Provide day-to-day QA oversight of sterile manufacturing operations
• Perform line clearances and verify equipment readiness prior to production activities
• Review batch manufacturing records for accuracy, completeness, and GMP compliance
• Support material dispensing, compounding, sterile filtration, filling, packaging, and related operations
• Monitor critical process parameters and ensure adherence to approved procedures
• Perform routine GMP inspections of production areas
• Verify environmental monitoring activities are completed according to requirements
• Support investigations involving deviations, non-conformances, and quality events
• Participate in CAPA implementation and follow-up activities
• Review manufacturing documentation, logbooks, and production records
• Support validation activities, engineering batches, media fills, and qualification efforts
• Maintain inspection readiness and support internal, customer, and regulatory audits
• Partner with Manufacturing, Quality Control, Validation, and Engineering teams to ensure product quality and compliance

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or a related scientific discipline
• 5+ years of experience within pharmaceutical manufacturing environments
• Experience supporting sterile injectable or aseptic manufacturing operations
• Strong understanding of cGMP requirements and FDA-regulated manufacturing
• Experience supporting batch record review and manufacturing documentation
• Familiarity with deviations, CAPAs, investigations, and quality systems
• Strong communication, problem-solving, and decision-making skills
• Ability to work effectively in a manufacturing floor environment

Preferred Qualifications

• Sterile injectable manufacturing experience
• Aseptic processing experience
• Shop-floor Quality Assurance experience
• Environmental monitoring and contamination control exposure
• FDA inspection or audit support experience
• Experience supporting validation, media fills, or process qualification activities
• Knowledge of Annex 1, GDP, and Data Integrity requirements

Ideal Background

• IPQA Specialist
• QA Specialist
• QA Operations Specialist
• QA Compliance Specialist
• Quality Assurance Associate
• QA Manufacturing Support
• Shop Floor QA
• QA Associate II/III
• Batch Record Review Specialist