About this role
Responsible for Manufacturing Quality Assurance work in the plant, including deviations resolution, product impact analysis, and CAPA support. Leads investigations, approves SOPs, oversees calibration and quality improvement programs, and ensures cGMP and company policy compliance.
Key Responsibilities
- Implement and maintain the Quality System effectiveness, Complete thorough plant event investigations and manage CAPA with product impact analysis and QA holds
- Approve standard operating procedures and calibration requests
- Audit commissioning and validation documentation and execute qualification/validation protocols
- Develop product quality plans using specifications, risk analyses and FMEA's, plus statistical quality programs and process monitoring
- Participate in the Validation Review Board and perform batch release for U.S. manufacturing sites
Technical Overview
Executes quality system effectiveness activities: audits commissioning and validation documentation, authors/executes qualification/validation protocols, reviews planned maintenance quality impacts, performs risk analyses and FMEA's, and implements statistical quality programs and process monitoring. Participates on the Validation Review Board and may perform batch release for U.S. manufacturing sites.
Ideal Candidate
The ideal candidate is a senior Quality Engineer with 6+ years of experience in Manufacturing, Quality, or Engineering, supporting Manufacturing Quality Assurance activities in a cGMP environment. They are strong in deviations, CAPA management, investigations, SOP approval, and auditing commissioning and validation documentation, including execution of qualification/validation protocols.
Must-Have Skills
Manufacturing Quality AssuranceCorrective and Preventive ActionCAPA systeminvestigationsstandard operating proceduresplant calibration programcGMP complianceauditing of commissioning and validation documentationqualification/validation protocolsrisk analysesFMEA's6+ years of overall experience in ManufacturingQuality or Engineering
Required Skills
Manufacturing Quality Assuranceresolution of deviationsproduct impact analysisCorrective and Preventive ActionCAPA systeminvestigationsstandard operating proceduresSOP approvalplant calibration programquality improvement programscGMP complianceAbbott policy complianceauditing of commissioning and validation documentationqualification protocolsvalidation protocolsplanned maintenance routines review and approvalproduct quality plansproduct specificationsquality specificationsquality plansrisk analysesFMEA'sstatistical quality programsprocess monitoring systemsValidation Review Boardbatch releaseAPIBulk DrugFinished goods manufacturing
Hard Skills
Manufacturing Quality Assuranceresolution of deviationsproduct impact analysisCorrective and Preventive ActionCAPA systeminvestigationsstandard operating proceduresSOP approvalplant calibration programquality improvement programscGMP complianceAbbott policy complianceauditing of commissioning and validation documentationqualification protocolsvalidation protocolsexecution of qualification/validation protocolsreview and approval of critical planned maintenance routinesProduct quality plansproduct specificationsquality specificationsquality plansrisk analysesFMEA'sstatistical quality programsprocess monitoring systemsbatch releaseValidation Review BoardManufacturing Quality Assurance functionQuality System effectiveness
Soft Skills
verbal and written communication skillsproblem solvinganalytical skillsinterpersonal relationscommunications skillsnegotiation skillsliaison and cooperative relationshipcross-functional collaboration
Keywords for Your Resume
Senior Quality EngineerSr. Quality EngineerQuality EngineerCombo Product External QualityManufacturing Quality Assurancedeviationsproduct impact analysisCorrective and Preventive ActionCAPACAPA systeminvestigationsstandard operating proceduresSOPcalibration programquality improvement programscGMPGood manufacturing practicesauditingcommissioning and validation documentationqualification protocolsvalidation protocolsqualification/validationrisk analysesFMEA'sstatistical quality programsprocess monitoring systemsValidation Review Boardbatch releaseAPIBulk DrugFinished goods manufacturing
Deal Breakers
Bachelor's degree, preferably in Biology, Chemistry or Engineering, 6+ years of overall experience in Manufacturing, Quality or Engineering, Ability to support cGMP compliance in manufacturing
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