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Quality Batch Release Specialist Jobs in Indiana

Qa Batch Release Technician
By Novartis At , Indianapolis, In $57,000 - $85,600 a year
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.
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).
Qa Batch Release Specialist
By Novartis At , Indianapolis, In $92,800 - $139,200 a year
CAPA management as well as improving processes within QA Batch release.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
2+ years of experience in a GxP Biopharmaceutical manufacturing operations. 1+ years of experience in a quality assurance role.
QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired.
Your responsibilities include, but are not limited to:

Are you looking for an exciting new opportunity to use your Quality Batch Release expertise? We are looking for an experienced Quality Batch Release Specialist to join our team and help ensure the quality of our products. You will be responsible for reviewing and approving batch records, ensuring compliance with cGMPs and other applicable regulations, and providing technical support to production and quality teams. If you are a detail-oriented professional with a passion for quality assurance, this could be the perfect job for you!

A Quality Batch Release Specialist is responsible for ensuring that all batches of products meet the quality standards set by the company. They are responsible for ensuring that all batches of products are safe and effective for use.

What is Quality Batch Release Specialist Skills Required?

• Knowledge of quality assurance principles and practices
• Ability to read and interpret technical documents
• Attention to detail
• Analytical and problem-solving skills
• Good communication and interpersonal skills
• Ability to work independently and as part of a team
• Knowledge of Good Manufacturing Practices (GMP)

What is Quality Batch Release Specialist Qualifications?

• Bachelor’s degree in a related field such as chemistry, biology, or engineering
• Certification in quality assurance or related field
• Experience in a quality assurance role

What is Quality Batch Release Specialist Knowledge?

• Knowledge of quality assurance principles and practices
• Knowledge of Good Manufacturing Practices (GMP)
• Knowledge of regulatory requirements

What is Quality Batch Release Specialist Experience?

• Previous experience in a quality assurance role
• Experience in a laboratory setting

What is Quality Batch Release Specialist Responsibilities?

• Review batch records and other documentation to ensure compliance with quality standards
• Perform quality control tests on batches of products
• Monitor production processes to ensure compliance with quality standards
• Investigate and resolve quality issues
• Prepare