In-Process Quality Assurance (IPQA) Specialist
In-Process Quality Assurance (IPQA) Specialist
Boca Raton, FL | Sterile Injectable Pharmaceutical Manufacturing | Onsite
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.
Key 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
Qualifications
- 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
- 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
This opportunity is ideal for someone looking to join a growing pharmaceutical manufacturing organization and play a hands-on role in ensuring quality, compliance, and operational excellence.
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