IPQA Specialist: Sterile Injectable Quality Oversight

Glenmark Pharmaceuticals

Monroe (NC)

On-site

USD 70,000 - 100,000

Full time

8 days ago

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Job summary

Glenmark Pharmaceuticals in Monroe, NC seeks an IPQA Specialist to provide quality support during manufacturing, filling and packaging. You will review BPR data, oversee visual inspection for sterile injectables, and ensure impact on cGMP compliance across operations.

The role emphasizes data review on the floor, adherence to SOPs, and collaboration with the QA team to prevent recalls and maintain product quality.

Qualifications

Bachelor’s degree in scientific discipline or closely related field.
3+ years of relevant pharmaceutical manufacturing experience.
Experience reviewing batch documentation on the floor and data review.
Strong technical writing, SOP, and regulatory knowledge (cGMP, 21 CFR, USP).

Responsibilities

Maintain quality system controls to ensure compliance and prevent recalls.
Perform line clearance and area approvals for Dispensing, Sampling, Manufacturing and Packaging.
Review batch manufacturing documentation and assist production with records.
Provide quality support during In-Process Sampling, Validation, Cleaning Verification activities.
Conduct compliance walk-throughs in Production and Warehouse and manage retain samples.
Ensure adherence to SOPs, Forms, Protocols and regulatory requirements.