QA Batch Release Specialist

QA Batch Release Specialist at Novartis Pharma Schweiz

• 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).

• Bachelor's Degree, preferably in Life Sciences, chemistry, or a related relevant degree. In lieu of a degree, 5 years in a role within the pharma industry that includes quality assurance and batch release experience will be considered.
• 2+ years of experience in GxP Biopharmaceutical manufacturing operations.
• 1+ year of experience in a quality assurance role.
• Cross–functional collaboration.
• QA and QC experience in the biotech pharmaceutical 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.

Salary: $81,200 – $150,800 per year, with performance‑based incentive and eligibility for equity awards.

Benefits:
Comprehensive health, life and disability benefits, 401(k) with company contribution and match, and a generous time‑off package including vacation, personal days, holidays and other leaves.

Location:

Novartis Pharma Schweiz