Katalyst CRO
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Quality Assurance Specialist
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Katalyst CRO . Get AI-powered advice on this job and more exclusive features. Responsibilities
Provide Quality Assurance (QA) support to Devens Site and reporting Manager through review and approval of Investigations and Corrective Actions. Make decisions on non-conformance issues, with a deep understanding of Quality Systems and Regulatory expectations. Review and approve Quality, Quality Control, Validation, and Automation documents. Approve Standard Operating Procedures (SOPs). Review and approve Validation documents such as risk assessments, protocols, test scripts, and reports. Approve change proposals, ensuring compliance with regulatory and internal guidelines. Coach across departments on Investigations, CAPAs, risk assessments, and Validation. Manage and prioritize multiple deliverables in a remote environment. Interpret complex data and make independent decisions. Requirements
Minimum 10 years' relevant experience in a QA role. B.S. in biological science, Engineering, biochemistry, or related discipline preferred. Extensive experience in GMP, GCP, or GXP, with at least 8 years focused on product quality; active membership in ASQ or ISPE preferred. Experience with QC equipment qualification and project management. Knowledge of biotech, drug manufacturing, or medical devices is highly desirable. Deep knowledge of US and EU cGMP regulations and GAMP 5. Familiarity with electronic systems like SAP, LIMS, TrackWise, Veeva Vault, and batch records. Strong technical writing and communication skills. Problem-solving background and data integrity knowledge. Attention to detail and ability to work in an FDA-regulated environment. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing This job posting is still active and available.
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Quality Assurance Specialist
role at
Katalyst CRO . Get AI-powered advice on this job and more exclusive features. Responsibilities
Provide Quality Assurance (QA) support to Devens Site and reporting Manager through review and approval of Investigations and Corrective Actions. Make decisions on non-conformance issues, with a deep understanding of Quality Systems and Regulatory expectations. Review and approve Quality, Quality Control, Validation, and Automation documents. Approve Standard Operating Procedures (SOPs). Review and approve Validation documents such as risk assessments, protocols, test scripts, and reports. Approve change proposals, ensuring compliance with regulatory and internal guidelines. Coach across departments on Investigations, CAPAs, risk assessments, and Validation. Manage and prioritize multiple deliverables in a remote environment. Interpret complex data and make independent decisions. Requirements
Minimum 10 years' relevant experience in a QA role. B.S. in biological science, Engineering, biochemistry, or related discipline preferred. Extensive experience in GMP, GCP, or GXP, with at least 8 years focused on product quality; active membership in ASQ or ISPE preferred. Experience with QC equipment qualification and project management. Knowledge of biotech, drug manufacturing, or medical devices is highly desirable. Deep knowledge of US and EU cGMP regulations and GAMP 5. Familiarity with electronic systems like SAP, LIMS, TrackWise, Veeva Vault, and batch records. Strong technical writing and communication skills. Problem-solving background and data integrity knowledge. Attention to detail and ability to work in an FDA-regulated environment. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing This job posting is still active and available.
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