IPQA Specialist: Visual QC & Manufacturing Quality

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Glenmark Pharmaceuticals in Monroe, NC seeks an IPQA Specialist to provide quality support during manufacturing—line clearance, material staging, label preparation, and in-process activities. You will review BPR data, oversee visual inspection programs for sterile products, and ensure regulatory compliance.

The role requires a Bachelor’s degree in a scientific field and 3+ years in pharmaceutical manufacturing, with strong technical writing and documentation skills, plus proficiency in MS

Qualifications

• Bachelor’s degree in a scientific discipline or closely related technical field
• 3+ years of relevant pharmaceutical manufacturing experience
• Experience in data review and floor activities (Dispensing, Pouching, Inspection, Packaging) is desirable

Responsibilities

• Maintain quality system controls to ensure state of compliance and prevent recalls.
• Reduce wastages and losses in the analysis process and improve efficiency.
• Perform line clearance and approval for use of areas/rooms for dispensing, sampling, manufacturing and packaging.
• Obtain and analyse utility samples as needed.
• Perform packaging label creation.
• Provide quality support during in-process sampling, validation, cleaning verification activities.
• Conduct compliance walk-throughs in production and warehouse.
• Maintain retain sample storage.
• Serve as SME for visual inspection for vial and syringe products.
• Perform AQL visual inspection of finished goods.
• Review batch manufacturing documentation and assist production with documentation.
• Ensure compliance with SOPs, forms, BPRs, protocols as needed.
• Operate in compliance with cGMP, 21CFR, USP, EP and ICH requirements.

Skills

Technical writing

cGMP knowledge

MS Word / Excel

Written and verbal communication

Documentation skills

Organization & time mgmt

Other skills

Education

Bachelor’s degree in scientific discipline

Job description

Glenmark Pharmaceuticals in Monroe, NC seeks an IPQA Specialist to provide quality support during manufacturing—line clearance, material staging, label preparation, and in-process activities. You will review BPR data, oversee visual inspection programs for sterile products, and ensure regulatory compliance.

The role requires a Bachelor’s degree in a scientific field and 3+ years in pharmaceutical manufacturing, with strong technical writing and documentation skills, plus proficiency in MS