About this role
Senior Quality Engineer responsible for plant Manufacturing Quality Assurance activities. The role focuses on deviations, product impact analysis, CAPA, investigations, SOP approvals, calibration program oversight, and cGMP compliance, while also supporting qualification and validation processes.
Key Responsibilities
- Implementing and maintaining the effectiveness of the Quality System
- Complete and document plant event investigations in the CAPA system
- Perform product impact analyses and place product on QA hold where appropriate
- Audit commissioning and validation documentation completed by others
- Develop and implement statistical quality programs and process monitoring systems
Technical Overview
Quality assurance in a manufacturing plant environment, including auditing commissioning/validation documentation, authoring/executing qualification/validation protocols, approving planned maintenance routines, and leading statistical quality and process monitoring programs. Ensures cGMP compliance and supports batch release for qualifying sites.
Ideal Candidate
The ideal candidate is a senior manufacturing quality professional with 6+ years of experience supporting Quality Engineering in a plant environment. They are strong in CAPA, deviation investigations, product impact analysis, cGMP compliance, and commissioning/validation documentation auditing, including writing and executing qualification/validation protocols.
Must-Have Skills
Manufacturing Quality AssuranceQuality System effectivenessinvestigations of plant events completed thoroughly and documented accuratelyincluded in the plant CAPA systemproduct impact analyses for plant eventsplaces product on QA hold where appropriateapproval of standard operating proceduresapproval of calibration requestsauditing of commissioning and validation documentationDevelop and implement statistical quality programs and process monitoring systems
Tools & Platforms
CAPA system
Required Skills
Manufacturing Quality Assuranceresolution of deviationsproduct impact analysesCorrective and Preventive Action (CAPA) systeminvestigationsstandard operating procedurescGMPcalibration programquality improvement programsauditing of commissioning and validation documentationqualification protocolsvalidation protocolscritical planned maintenance routines review and approvalproduct quality plansquality specificationsrisk analysesFMEA'sstatistical quality programsprocess monitoring systemsbatch release
Hard Skills
Manufacturing Quality Assuranceresolution of deviationsproduct impact analysescorrective and preventive actionCorrective and Preventive Action (CAPA) systeminvestigationsinvestigation documentationapproval of standard operating procedurescGMPcalibration program oversightquality improvement programscommissioning and validation documentation auditingqualification protocolsvalidation protocolsSystem Functional and/or Design Specificationscritical planned maintenance routines review and approvalqualification/validation lifecycledevelop product quality plansquality specificationsrisk analysesFMEA'sFailure Modes and Effects Analyses (FMEA's)statistical quality programsprocess monitoring systemsbatch releaseAPIBulk Drug or Finished goods manufacturing compliancequality/compliance managementQuality System effectiveness
Soft Skills
good verbal and written communication skillsgood problem solving and analytical skillsgood interpersonal relations / communications skillsgood negotiation skillsleading and participating in investigationsmaintaining liaison and cooperative relationship with other Quality areas and Plant departmentscross-functional collaboration
Keywords for Your Resume
Senior Quality EngineerQuality EngineerManufacturing Quality AssuranceManufacturing QualitydeviationsCorrective and Preventive Action (CAPA)CAPA systemproduct impact analysesQA holdinvestigationsstandard operating procedurescGMPcalibration programcommissioning and validation documentationqualification protocolsvalidation protocolsrisk analysesFMEAFailure Modes and Effects Analyses (FMEA's)statistical quality programsprocess monitoring systemsbatch releaseAPI manufacturingBulk Drug manufacturing
Deal Breakers
6+ years of overall experience in Manufacturing, Quality or Engineering, Bachelor's degree, preferably in Biology, Chemistry or Engineering, Must demonstrate experience with CAPA, investigations, and cGMP compliance in a manufacturing environment
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