QA Batch Release Specialist - 3rd Shift
8910 Purdue Road Indianapolis, IN 46268 US
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
- Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
- Controlled issuance of batch records in preparation for manufacturing.
- Perform 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.
- Ensure Specifications in place and are within GMP compliance
- Support metric tracking of documentation and release data to ensure continuous improvement.
- Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
- CAPA management as well as improving processes within QA Batch release
- Organize and file all executed and associated GMP documentation (e.g. batch records).
- Maintain batch documentation library (record check-in, check-out, follow-up, and distribution)
- Other related duties as assigned.
Education & Qualification
- Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree.
- Experiences 5+ years of experience in a GxP Biopharmaceutical manufacturing operations 4+ years of experience in a quality assurance role
- Cross functional collaboration
- Functional Breadth
- QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired
- Proven track record and practical experience with cGMP requirements
- Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
- Continuous Learning (Dyn. Knowledge Development)
- Digital & Technology Savvy
- Operational Excellence
- Being Resilient
- Breakthrough Analysis
- Interpersonal Savvy
- Organizational Savvy
Technical / Function Skills & Knowledge
- Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
- Knowledge of IT Applications & tools
- Quality Assurance
- Quality Control (QC) Testing
- Quality Standards
- Sterility Assurance and Aseptic Manufacturing
- Quality oriented with attention to details
- Strong organizational and time management skills
- Developed management and communication skills
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