About this role
This Quality Engineer role leads Manufacturing Quality Assurance activities at the plant. You will drive deviation resolution, product impact analysis, CAPA documentation, investigations, SOP approvals, calibration oversight, and statistical quality/acceptance sampling to ensure cGMP compliance.
Key Responsibilities
- Resolve manufacturing deviations and perform product impact analysis
- Lead and document investigations and ensure CAPA system updates
- Approve standard operating procedures and calibration requests
- Oversee plant calibration program and quality improvement programs
- Implement statistical quality programs and acceptance sampling
Technical Overview
The role focuses on plant quality systems for API, Bulk Drug, and finished goods manufacturing. Responsibilities include validation support for process equipment, CAPA system management, investigations, calibration program oversight, and statistical quality programs with acceptance sampling.
Ideal Candidate
The ideal candidate is a Manufacturing Quality Assurance professional with 2+ years of experience resolving deviations, running investigations, and managing CAPA for plant events. They are strong in cGMP compliance, standard operating procedures approval, calibration program oversight, and statistical quality/acceptance sampling.
Must-Have Skills
Manufacturing Quality Assuranceresolution of deviationsproduct impact analysiscorrective and preventive actioninvestigations and documentationCAPA systemstandard operating procedures approvaloversight of the plant calibration programcGMP compliancequality/compliance management knowledge2+ years of overall experience in ManufacturingQuality or Engineering
Tools & Platforms
CAPA system
Required Skills
Manufacturing Quality Assurancedeviations resolutionproduct impact analysiscorrective and preventive actionCAPA systeminvestigationsstandard operating procedurescalibration programquality improvement programscGMP complianceQuality Systemvalidation and certification of new process equipmentstatistical quality programsacceptance samplingQA holdAPIBulk Drugfinished goods manufacturing
Hard Skills
Manufacturing Quality Assurancedeviations resolutionproduct impact analysiscorrective and preventive actionCAPA systeminvestigationsstandard operating proceduresplant calibration programquality improvement programscGMP complianceQuality System effectivenessquality goalsAPIBulk Drug manufacturingfinished goods manufacturingquality / compliance managementvalidation and certification of new process equipmentcertified systems capability reviewvalidation review boardstatistical quality programsacceptance samplingproduct/process limits assignmentQA hold
Soft Skills
Good verbal and written communication skillsGood problem solving and analytical skillsGood interpersonal relations / communications skillsGood negotiation skillsLeading and participating in investigationsMaintains liaison and cooperative relationshipCross-functional collaboration with other Quality areas and Plant departments
Keywords for Your Resume
Quality EngineerManufacturing Quality Assurancedeviationsproduct impact analysiscorrective and preventive actionCAPA systeminvestigationsstandard operating proceduresstandard operating procedures approvalcalibration programquality improvement programscGMPcGMP and AbbVie policy complianceQuality Systemvalidation and certification of all new process equipmentstatistical quality programsacceptance samplingQA holdAPIBulk Drugfinished goods manufacturingquality / compliance managementapplicable regulations
Deal Breakers
2+ years of overall experience in Manufacturing, Quality or Engineering, Demonstrated knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing, Must be able to perform investigations and product impact analyses and apply QA hold appropriately
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile