Arrowhead Pharmaceuticals, Inc.
Senior Specialist, Quality Assurance (2nd Shift)
Arrowhead Pharmaceuticals, Inc., Verona, Wisconsin, United States, 53593
Senior Specialist, Quality Assurance (2nd Shift)
Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. Responsibilities Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing records. Perform QA on the floor and manufacturing room release. Review and release of completed manufacturing batch documentation including Quality Control (QC) and Analytical Development (AD) data and issuance of Certificates of Analysis. Writing, review, change control, approval, issuance, and organization of applicable procedural documents. Issuance, review, tracking, and completion of internal quality events (QEs), such as deviations, out of specifications (OOS), and CAPAs. Organization and control of quality, compliance, and project related documentation. Maintain knowledge of current compliance expectations and regulations pertaining to drug development. Collaborate with, and provide quality support for, other departments (Manufacturing, QC, AD, Project Management, etc.). Participate in meetings as the QA team representative as needed. Additional duties as assigned. Requirements Bachelor's degree in a science discipline, or equivalent required. 8 years of experience working in a regulated environment with preference to quality assurance and/or manufacturing experience. Excellent written and verbal communication skills and ability to communicate effectively with internal and external parties. Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best in class quality assurance protocols. Highly motivated team player willing to contribute to a growing pharmaceutical organization. Ability to work independently and manage priorities within a fast-paced environment. A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead. Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents. Understanding of document control requirements in an FDA regulated organization. Preferred Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15). Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet. Prior experience with use of an electronic document management system in a regulated environment. Wisconsin pay range: $90,000$110,000 USD. Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. #J-18808-Ljbffr
Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. Responsibilities Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing records. Perform QA on the floor and manufacturing room release. Review and release of completed manufacturing batch documentation including Quality Control (QC) and Analytical Development (AD) data and issuance of Certificates of Analysis. Writing, review, change control, approval, issuance, and organization of applicable procedural documents. Issuance, review, tracking, and completion of internal quality events (QEs), such as deviations, out of specifications (OOS), and CAPAs. Organization and control of quality, compliance, and project related documentation. Maintain knowledge of current compliance expectations and regulations pertaining to drug development. Collaborate with, and provide quality support for, other departments (Manufacturing, QC, AD, Project Management, etc.). Participate in meetings as the QA team representative as needed. Additional duties as assigned. Requirements Bachelor's degree in a science discipline, or equivalent required. 8 years of experience working in a regulated environment with preference to quality assurance and/or manufacturing experience. Excellent written and verbal communication skills and ability to communicate effectively with internal and external parties. Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best in class quality assurance protocols. Highly motivated team player willing to contribute to a growing pharmaceutical organization. Ability to work independently and manage priorities within a fast-paced environment. A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead. Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents. Understanding of document control requirements in an FDA regulated organization. Preferred Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15). Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet. Prior experience with use of an electronic document management system in a regulated environment. Wisconsin pay range: $90,000$110,000 USD. Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. #J-18808-Ljbffr