Pharma Batch Release Quality Analyst

Guerbet

Raleigh (NC)

On-site

USD 90,000 - 120,000

Full time

14 days+

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Job summary

Guerbet in Raleigh is seeking a Supply Chain Quality Analyst to lead end-to-end batch release, from inbound raw materials to finished goods, in a GDP/cGMP environment. You will ensure compliance, document integrity and cross‑functional alignment with QC, QA and manufacturing.

The role emphasizes resolving holds, tracking release KPIs, and driving CAPA‑driven improvements. A Bachelor’s in Life Sciences or related field and 3+ years in batch release or quality systems are required, with ERP/WMS

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, or equivalent.
3+ years of experience in pharmaceutical batch release or quality systems.
Experience facilitating inbound raw material release and finished goods batch release.
Knowledge of FDA 21 CFR 210/211, 21 CFR Part 11, and EU GDP requirements.
Experience with ERP/WMS documentation and electronic quality systems.

Responsibilities

Own end-to-end batch release lifecycle: inbound raw materials, intermediates, and finished goods—reviewing batch records and COAs.
Coordinate cross-functional teams to resolve holds and communicate release status to stakeholders.
Monitor batch release KPIs and drive process improvements using CAPA and SOP optimization.
Facilitate GMP alignment at warehouse–production boundary (label control, FEFO/traceability).
Escalate nonconformances and deviations impacting release timelines and initiate investigations per SOPs.
Ensure data integrity per ALCOA+ and compliance with 21 CFR Part 11, GDP, and internal Quality Systems.
Review and update SOPs/WIs related to batch release and material inbound quality; support training.
Perform ad-hoc quality checks and participate in QA disposition meetings.
Ensure timely release of inbound material and excipient batches to prevent manufacturing delays.