Qa Operations Lot Review Jobs

Provide daily leadership and management for the QA Operations Team.

Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity

QA and QC experience in pharmaceutical or biotechnology pharmaceutical industry with environmental monitoring & cleanliness zones

Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.

Assist functional areas with achieving timely and compliant final product disposition of the product.

Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.

Possess effective task/time management organization skills.

Escalate to QA Operations management of any potential deviations, compliance risks.

Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment preferably in QA Operations.

Prefers candidate with QA Operations experience with On-The-Floor oversight

Excellent verbal and written communication skills.

Previous experience working in Quality Assurance, Quality Control, or Drug Substance or Drug Product manufacturing

Participation in routine meetings as assigned by management.

Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred

Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.

5-10 years of GMP experience

Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)

Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations