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Senior QA Specialist, Microbial Contamination Control & Cleaning(m/w/x)
Leading contamination control strategy for Bioconjugates manufacturing. Extensive GMP pharmaceutical industry experience required. Agile career path, high-performance compensation programs.
Requirements
- Academic degree in Chemistry, Biotechnology, or Life Science
- Extensive GMP pharmaceutical industry experience
- Microbial contamination control experience
- Environmental Monitoring programs experience
- General knowledge of manufacturing processes
- General knowledge of contamination control strategy
- General knowledge of cleaning procedures
- General knowledge of analytical methods
- Proactive, detail-oriented, problem-solving mindset
- Continuous-improvement mindset
- Experience interacting with health authorities desired
- Independence
- Sociability
- Pro-activeness
- Customer focus
- Team player values
- Experience with TrackWise preferred
- Experience with SAP preferred
- Experience with Microsoft Office preferred
- English fluency required
- German language skills an asset
Tasks
- Lead contamination control strategy for Bioconjugates
- Ensure end-to-end compliance in manufacturing facilities
- Manage bioburden control, hygiene, and environmental monitoring
- Conduct risk and gap assessments, change requests, deviations, and investigations
- Author and approve GMP documentation and records
- Collaborate with cross-functional teams to identify and mitigate risks
- Drive deviation management and continuous improvement
- Strengthen contamination prevention practices
- Identify and assess contamination risks
- Maintain the Contamination Control Strategy (CCS)
- Guide stakeholders with microbiology and QA expertise
- Ensure robust quality culture and operational compliance
- Act as QA Microbial Contamination Control and cleaning SME
- Participate in meetings, audits, and inspections
- Review and approve routine cleaning documents
- Review and release SOPs, Master Batch Records, Material Specifications, and other records
- Identify and communicate emerging QA topics
- Develop new or established Quality and Compliance strategies
- Support continuous improvement programs
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Basic
Tools & Technologies
- TrackWise
- SAP
- Microsoft Office
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Compensation programs for high performance
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Tailored local benefits
- Relocation assistance
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Senior QA Specialist, Microbial Contamination Control & Cleaning(m/w/x)
Leading contamination control strategy for Bioconjugates manufacturing. Extensive GMP pharmaceutical industry experience required. Agile career path, high-performance compensation programs.
Requirements
- Academic degree in Chemistry, Biotechnology, or Life Science
- Extensive GMP pharmaceutical industry experience
- Microbial contamination control experience
- Environmental Monitoring programs experience
- General knowledge of manufacturing processes
- General knowledge of contamination control strategy
- General knowledge of cleaning procedures
- General knowledge of analytical methods
- Proactive, detail-oriented, problem-solving mindset
- Continuous-improvement mindset
- Experience interacting with health authorities desired
- Independence
- Sociability
- Pro-activeness
- Customer focus
- Team player values
- Experience with TrackWise preferred
- Experience with SAP preferred
- Experience with Microsoft Office preferred
- English fluency required
- German language skills an asset
Tasks
- Lead contamination control strategy for Bioconjugates
- Ensure end-to-end compliance in manufacturing facilities
- Manage bioburden control, hygiene, and environmental monitoring
- Conduct risk and gap assessments, change requests, deviations, and investigations
- Author and approve GMP documentation and records
- Collaborate with cross-functional teams to identify and mitigate risks
- Drive deviation management and continuous improvement
- Strengthen contamination prevention practices
- Identify and assess contamination risks
- Maintain the Contamination Control Strategy (CCS)
- Guide stakeholders with microbiology and QA expertise
- Ensure robust quality culture and operational compliance
- Act as QA Microbial Contamination Control and cleaning SME
- Participate in meetings, audits, and inspections
- Review and approve routine cleaning documents
- Review and release SOPs, Master Batch Records, Material Specifications, and other records
- Identify and communicate emerging QA topics
- Develop new or established Quality and Compliance strategies
- Support continuous improvement programs
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Basic
Tools & Technologies
- TrackWise
- SAP
- Microsoft Office
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Compensation programs for high performance
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Tailored local benefits
- Relocation assistance
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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