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Quality Batch Release Specialist Jobs

Quality Assurance Specialist (Batch Record Reviewer)
By Orion At , North Chicago
Release batch records in electronic systems according to global, local, customer and regulatory requirements
2+ year overall experience in Manufacturing, Quality or Engineering
Minimum 2 years experience in Batch Record Release strongly preferred
Knowledge of GMP regulations and standards affecting pharmaceutical products
Good verbal and written communication skills
Demonstrated analytical skills and attention to detail
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.
Quality Manager - Small Batch Manufacturing
By Kraft Heinz Company At , Glenview, Il
Minimum 5 years experience in quality management
Highly proficient management skills and ability to manage changing project deadlines and priorities with ease.
Lead implementation of Kraft Heinz Management System (KHMS) and associated policies at the different sites
Review quality management system metrics with the Pod Quality and leadership team on a regular basis
A proven goal orientated self-starter capable of being remotely managed.
Expected Experience & Required Skills
Lead Specialist, Qa Batch Disposition
By Catalent At , Harmans, 21077, Md
Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish preferred.
Medical, dental and vision benefits effective day one of employment
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career!
Independently executes batch record review for completeness, accuracy and cGMP compliance.
Release Of Information Specialist
By University of Washington At , Seattle, 98195, Wa $3,331 - $4,106 a month

A higher degree of healthcare.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [email protected].

Release Of Information Specialist
By DCH Health System At Tuscaloosa, AL, United States
Responds to requests for medical information from attorneys, subpoenas, court orders, Risk Management, and legal counsel.
Requires use of electronic mail, time and attendance software, learning management software and intranet.
Generates invoices, letters, and release of information acknowledgements through Chartmaxx and/or Meditech.
Performs compliance requirements as outlined in the Employee Handbook.
Requires ability to withstand pressures of constant deadlines, audits, educational demands and changing healthcare environment.
Displays a willingness to take on responsibilities and challenges.
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).
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.
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:
Release Of Information Specialist - Remote In Arizona
By UnitedHealth Group At , Phoenix, 85002, Az
Proficiency with Microsoft Office and knowledge, experience and/or training in accurate data entry, office equipment and procedures
Associate's Degree (or higher) in Health Information Management
Related experience within healthcare environment
Experience working within the health care Industry
Experience working in a hospital, physician's office or medical clinic setting
Experience working in a call center
Quality Control Release Engineer
By Canvas Medical At , San Francisco, Ca
The ability to stay organized, prioritize, and stay on top of weekly tasks. Project management experience is preferred
Experience using configuration management and automation tools such as CloudFormation or Terraform
Strong understanding of the software development life cycle, git, branching strategy, and especially the software release management process
Prepare, coordinate, document, offer trainings, and oversee the release process
Manage the JIRA Release Board
Bachelor’s degree in related field or qualifying years of experience

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