{"schemaVersion":"jobsearcher.job.v1","id":"a3bdbf421af7c44adbc681a0","url":"https://jobsearcher.com/jobs/a3bdbf421af7c44adbc681a0","canonicalUrl":"https://jobsearcher.com/jobs/a3bdbf421af7c44adbc681a0","title":"QA Lead Technical Operations, Projects","description":"Job Description/ Responsibilities:\r\n* Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and\r\napproval of Investigations and Corrective Actions.\r\n* Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations\r\n* Reviews and approves Quality, Quality Control, Validation and Automation related documents\r\n* Review and approves Standard Operating Procedures (SOPs).\r\n* Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and\r\nsummary reports.\r\n* Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet\r\nexternal regulatory and internal WWQC guidelines and requirements.\r\n* Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk\r\nassessments and Validation.\r\n* Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working\r\nenvironment\r\n* Able to interpret complicated data and make sound decisions, Independently\r\nThis position will regularly interact with\r\nReporting Manager\r\nSometimes will interact with departments listed below\r\nQuality Control\r\nManufacturing Operations\r\nManufacturing Engineering\r\nManufacturing Science and Technology (MS&T)\r\nValidation\r\nSite Engineering\r\nDigital Plant\r\nEducation, Experience, and Qualifications:\r\n* Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,\r\nbiochemistry, or related discipline, or its equivalent is preferred.\r\n* Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product\r\nquality. Preferred Active member of ASQ or ISPE.\r\n* Prior experience of QC equipment Qualification and some project management experience\r\n* Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is\r\nhighly desirable.\r\n* Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.\r\n* Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic\r\nor paper based batch records desirable.\r\n* Excellent Technical writing and oral communication skills are required.\r\n* Background in problem solving\r\n* Knowledge of Data integrity principles\r\n* Proven attention to details\r\n* Comfortable working in an FDA regulated environment.\r\nContractor must be able to come onsite Monday through Friday - 1st shift\r\nJ-18808-Ljbffr","company":"TechDigital Group","rawCompany":"techdigital group","city":"Harvard","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-06-25T01:21:33.973Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"QA Lead Technical Operations, Projects","description":"Job Description/ Responsibilities:\r\n* Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and\r\napproval of Investigations and Corrective Actions.\r\n* Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations\r\n* Reviews and approves Quality, Quality Control, Validation and Automation related documents\r\n* Review and approves Standard Operating Procedures (SOPs).\r\n* Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and\r\nsummary reports.\r\n* Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet\r\nexternal regulatory and internal WWQC guidelines and requirements.\r\n* Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk\r\nassessments and Validation.\r\n* Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working\r\nenvironment\r\n* Able to interpret complicated data and make sound decisions, Independently\r\nThis position will regularly interact with\r\nReporting Manager\r\nSometimes will interact with departments listed below\r\nQuality Control\r\nManufacturing Operations\r\nManufacturing Engineering\r\nManufacturing Science and Technology (MS&T)\r\nValidation\r\nSite Engineering\r\nDigital Plant\r\nEducation, Experience, and Qualifications:\r\n* Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,\r\nbiochemistry, or related discipline, or its equivalent is preferred.\r\n* Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product\r\nquality. Preferred Active member of ASQ or ISPE.\r\n* Prior experience of QC equipment Qualification and some project management experience\r\n* Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is\r\nhighly desirable.\r\n* Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.\r\n* Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic\r\nor paper based batch records desirable.\r\n* Excellent Technical writing and oral communication skills are required.\r\n* Background in problem solving\r\n* Knowledge of Data integrity principles\r\n* Proven attention to details\r\n* Comfortable working in an FDA regulated environment.\r\nContractor must be able to come onsite Monday through Friday - 1st shift\r\nJ-18808-Ljbffr","datePosted":"2026-06-25T01:21:33.973Z","dateModified":"2026-06-25T01:21:33.973Z","hiringOrganization":{"@type":"Organization","name":"TechDigital Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Harvard","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a3bdbf421af7c44adbc681a0"},"url":"https://jobsearcher.com/jobs/a3bdbf421af7c44adbc681a0"}}