Lonza
Biotech Manufacturing
Specialist,QAOperations(MasterBatchRecord)
Neural analysis suggests this role is
optimal for Mid candidates.
“Specialist, QA Operations (Master Batch Record) at Lonza. Skills: Quality Assurance, GMP, Batch Records. Provide day to day Quality Assurance activities support. Review batch records/logbooks; escalate deviations promptly”
What You'll Achieve.
Ensure timely closure of deviation investigations; Ensure compliance during changeovers
Industry & Context.
Identify cGMP gaps and drive corrective actions
What They're Looking For.
Must Have
Degree with 2-5 years of experience in a in a similar type of industry or a similar job role, Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7), Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility, Good oral and written communication skills, Meticulous and Systematic, Team player, with focus on safety, quality and timelines
Nice to Have
Pleasant personality
What You'll Do.
Provide day to day Quality Assurance activities support
Review batch records/logbooks; escalate deviations promptly
Compile lot genealogy and prepare disposition packages for product release
Oversee product status and shipping documentation
Manage quality tag-out system
Review/approve deviation investigations using ensure timely closure
Monitor CAPA implementation and closure
Escalate shop floor process events per SOPs
Support changeovers and ensure compliance
Provide QA oversight for MBRs
Review quality-related change requests
Identify cGMP gaps and drive corrective actions
Conduct shop floor QA walk-downs and provide feedback
Support regulatory inspections and customer audits
How You'll Work.
Team & Collaboration
Lead/coordinate team projects; Lead/coordinate stakeholder engagement
Communication Scope
Good oral and written communication skills
Full Job Description
As a QA specialist you will provide day to day Quality Assurance activities support in accordance with approved SOPs/Policies for a large scale GMP Biotech Manufacturing facility. **What you’ll get** * An agile career and dynamic working culture in a global life sciences leader. * An inclusive and ethical workplace that values diversity and integrity. * Competitive compensation programs that recognize high performance. * Professional growth opportunities through cross-functional projects and global exposure. * Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums. * Company transport provided from designated MRT locations to and from the Tuas site. * Access to Lonza’s full suite of employee benefits: [www.lonza.com/careers/benefits](https://www.lonza.com/careers/benefits) **What you’ll do** * Review batch records/logbooks; escalate deviations promptly * Compile lot genealogy and prepare disposition packages for product release * Oversee product status and shipping documentation * Manage quality tag-out system * Review/approve deviation investigations using RCA; ensure timely closure * Monitor CAPA implementation and closure * Escalate shop floor process events per SOPs * Support changeovers and ensure compliance * Provide QA oversight for MBRs, SOPs, forms, and logbooks * Review quality-related change requests * Identify cGMP gaps and drive corrective actions * Conduct shop floor QA walk-downs and provide feedback * Support regulatory inspections and customer audits * Lead/coordinate team projects and stakeholder engagement * Act as Change Agent/Reviewer/Approver for quality documents * Support deviation and change control management * **What we’re looking for** * Degree with 2-5 years of experience in a in a similar type of industry or a similar job role. * Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7). * Fair knowledge and experience of the practical and theore
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