Quality Assurance Associate - Batch Release Specialist
By Above & Beyond Talent Acquisition, Inc. At Princeton, NJ, United States
Manage Quality Management Systems, including deviation investigation, CAPA, and minor Change Control.
BA/BS (preferably in Science) or High school diploma with equivalent work experience.
Minimum 2 years of experience in cGMP manufacturing. Previous Quality Assurance experience is preferred.
Conduct meticulous batch record reviews, encompassing Quality Control, manufacturing, packaging, and Quality Assurance records to ensure accuracy and adherence to standards.
Oversee Quality Assurance activities at Contract Manufacturing Organizations (CMOs) involved in the production and packaging of pharmaceutical products.
Collaborate with external partners to identify areas of improvement and ensure compliance with CGMPs and regulatory expectations.
Exceptional Release Specialist Jobs
By Legend Biotech At Raritan, NJ, United States
A minimum of a Bachelor’s degree in science, engineering or related field or equivalent experience required. Advanced degree preferred.
A minimum of six (5) years of professional relevant business experience.
Demonstrated experience in leading cross-functional teams and responding to urgent issues.
Knowledge and solid understanding of cGMP regulations and FDA/EU guidance.
Excellent written and oral communication skills
Collaborate cross functionally to quickly escalate issues which may delay the release of a batch or require a remanufacture.

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