Quality Assurance Specialist

The In-Process Quality Assurance (IPQA) Specialist is responsible for providing real-time quality oversight of manufacturing operations to ensure sterile injectable pharmaceutical products are manufactured in compliance with current cGMP, approved procedures, batch manufacturing records, regulatory requirements, and quality standards. This role serves as the primary quality representative on the manufacturing floor, ensuring product quality, process compliance, and timely resolution of quality issues throughout production.

Salary Range
: $75,000-$95,000 annuall

yIn-Process Quality Assurance (IPQA) Specialis

tDepartment
:
Quality Assuranc

eReports To
:
Senior Manager, Quality Assurance

• Perform routine in-process quality assurance inspections throughout manufacturing operation
• Provide QA oversight during all critical manufacturing activities, including
• Sterile filtration
• Aseptic filling
• Stoppering and capping
• Visual inspection
• Packaging operations
• Conduct line clearance prior to manufacturing and packaging activities
• Verify equipment cleanliness, calibration status, and readiness before production
• Review manufacturing documentation for accuracy, completeness, and compliance
• Ensure manufacturing activities adhere to approved Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Standard Operating Procedures (SOPs), and cGMP requirement
• Perform in-process sampling in accordance with approved procedures
• Monitor critical process parameters and verify compliance with established specification
• Verify environmental monitoring activities are completed according to schedule and procedure
• Conduct routine GMP inspections of manufacturing and production area
• Identify, document, and report deviations, non-conformances, and quality event
• Participate in deviation investigations, root cause analyses, and implementation of Corrective and Preventive Actions (CAPA)
• Review equipment logbooks, production records, and supporting documentation for completeness and accuracy.
• Verify proper status labeling, material identification, and equipment identification throughout manufacturing operations.
• Support media fills, process validations, equipment qualifications, engineering batches, and other validation activitie
• Ensure compliance with gowning requirements and aseptic manufacturing technique
• Escalate quality concerns promptly and recommend appropriate corrective action
• Support internal audits, customer audits, and regulatory inspection
• Promote continuous improvement initiatives and maintain GMP compliance throughout manufacturing operation
• Perform investigations related to manufacturing deviations and Out-of-Specification (OOS) result
• Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) and support batch disposition and release activitie
• Review audit trails for manufacturing equipment and electronic systems to ensure data integrity and regulatory compliance

• Education Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology, or another related life sciences discipline

• Minimum of 5-10 years of Quality Assurance or In-Process Quality Assurance experience within the pharmaceutical industry
• Hands-on experience in sterile injectable manufacturing is required
• Demonstrated experience supporting aseptic processing operations in a GMP-regulated environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP).
• Working knowledge of FDA 21 CFR Parts 210 and 211.
• Familiarity with EU GMP Annex 1 requirements
• Knowledge of aseptic manufacturing processes and contamination control strategies
• Experience with batch record review and documentation practice
• Line clearance and in-process inspection expertise
• Understanding of environmental monitoring programs
• Knowledge of data integrity principles (ALCOA+).
• Experience conducting deviation investigations and supporting CAPA implementation
• Strong understanding of Good Documentation Practices (GDP).
• Excellent attention to detail and observational skills
• Strong analytical, problem-solving, and decision-making abilities
• Effective written and verbal communication skills.
• Ability to work collaboratively with Manufacturing, Quality Control, Validation, Engineering, and other cross-functional teams
• Ability to work in cleanroom environments while following gowning and aseptic requirement
• Manufacturing and cleanroom environment requiring adherence to gowning procedures and aseptic practice
• May require standing, walking, and frequent presence on the production floor for extended periods.
• Flexibility to support multiple shifts, weekends, or production schedules as needed.