CH12 Lonza AG
Senior QA Specialist(m/w/x)
Full-timeOn-siteSenior
Visp
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VAVaxcyte
Quality Assurance Specialist III, External Manufacturing(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Reviewing executed batch records and deviation documents for clinical-stage vaccine innovation. Minimum 5 years QA experience with cGMP and FDA/EMA regulations required. Equity component.
Requirements
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related field
- Minimum 5 years experience in QA, batch record review, manufacturing, or quality systems management
- Other education/experience combinations considered
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and pharmaceutical quality standards
- Experience managing batch record review and deviation resolution
- Electronic batch record review experience advantageous
- Great organization skills
- Attention to detail
- In-depth understanding of biologics manufacturing operations
- Ability to prioritize multiple assignments and changing priorities
- Excellent problem-solving skills
- Ability to manage complex investigations and root cause analyses
- Strong written communication skills
- Strong verbal communication skills
- Ability to clearly present quality issues to cross-functional teams
Tasks
- Review executed batch records (paper and electronic)
- Review product and program-specific documents
- Approve deviation and change control documents
- Document batch review comments
- Collaborate with cross-functional teams
- Serve as primary QA contact with CDMOs
- Perform product disposition activities
- Review and approve documentation
- Archive documents
- Review raw data
- Support deviations, change controls, and CAPAs
- Participate in investigations and problem resolution
- Resolve conflicts independently
- Participate in technology transfer and validation teams
- Provide QA guidance on procedures and policies
- Review documents for internal and external transfers
- Edit and approve controlled documents
- Maintain accurate quality documentation
- Ensure compliance with global regulatory requirements
- Collaborate with global manufacturing and external vendors
- Address quality issues
- Support product development and commercialization
- Identify gaps in batch record review processes
- Recommend and implement best practices
- Participate in ERP platform implementation
- Support internal audits
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Equity component
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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VAVaxcyte
Quality Assurance Specialist III, External Manufacturing(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Reviewing executed batch records and deviation documents for clinical-stage vaccine innovation. Minimum 5 years QA experience with cGMP and FDA/EMA regulations required. Equity component.
Requirements
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related field
- Minimum 5 years experience in QA, batch record review, manufacturing, or quality systems management
- Other education/experience combinations considered
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and pharmaceutical quality standards
- Experience managing batch record review and deviation resolution
- Electronic batch record review experience advantageous
- Great organization skills
- Attention to detail
- In-depth understanding of biologics manufacturing operations
- Ability to prioritize multiple assignments and changing priorities
- Excellent problem-solving skills
- Ability to manage complex investigations and root cause analyses
- Strong written communication skills
- Strong verbal communication skills
- Ability to clearly present quality issues to cross-functional teams
Tasks
- Review executed batch records (paper and electronic)
- Review product and program-specific documents
- Approve deviation and change control documents
- Document batch review comments
- Collaborate with cross-functional teams
- Serve as primary QA contact with CDMOs
- Perform product disposition activities
- Review and approve documentation
- Archive documents
- Review raw data
- Support deviations, change controls, and CAPAs
- Participate in investigations and problem resolution
- Resolve conflicts independently
- Participate in technology transfer and validation teams
- Provide QA guidance on procedures and policies
- Review documents for internal and external transfers
- Edit and approve controlled documents
- Maintain accurate quality documentation
- Ensure compliance with global regulatory requirements
- Collaborate with global manufacturing and external vendors
- Address quality issues
- Support product development and commercialization
- Identify gaps in batch record review processes
- Recommend and implement best practices
- Participate in ERP platform implementation
- Support internal audits
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Equity component
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Vaxcyte
Industry
Pharmaceuticals
Description
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
Not a perfect match?
- CH12 Lonza AG
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