Qureos Mentor

Arrowhead Pharmaceuticals

<div>
 
 Arrowhead Pharmaceuticals, Inc. (Nasdaq{{:}}&nbsp; ARWR) 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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead&rsquo;s RNAi-based therapeutics leverage this natural pathway of gene silencing.
 
 
 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 depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
 
 
 Arrowhead&rsquo;s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; San Diego, CA, and a state of the art manufacturing facility in Verona, WI.&nbsp; Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.&nbsp;
 
 
 
 The Position
 
 
 
 The purpose of this position is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. The incumbent will review vendor documentation and perform lot disposition per applicable quality agreements as well as capture quality data and generate metrics for vendors. The incumbent will be expected to interact with internal departments as well as multiple contract organizations to support ongoing pre-clinical and clinical development programs at Arrowhead Pharmaceuticals, Inc.
 
 
 
 Responsibilities
 
 
 <ul>
 <li>
 Interact with personnel companywide to obtain the necessary information and details to provide quality assurance support of development, clinical, and commercial programs.
 </li>
 <li>
 Review and approve vendor generated documentation, including but not limited to, master and executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports.
 </li>
 <li>
 Perform lot disposition and generate certificates of compliance (CoC) as necessary.
 </li>
 <li>
 Collaborate with vendors on quality events and non-conformances as outlined in the applicable quality agreement.
 </li>
 <li>
 Review and release of completed manufacturing batch documentation including Quality Control data and issuance of Certificates of Analysis.
 </li>
 <li>
 Organization and control of quality, compliance, and project related documentation.
 </li>
 <li>
 Maintain knowledge of current compliance expectations and regulations pertaining to drug development
 </li>
 <li>
 Collaborate with, and provide quality support for, other departments (QC, Project Management, Toxicology, Clinical Operations, Supply Chain, etc.)
 </li>
 <li>
 Participate in meetings with vendors and external organizations as the QA team representative.
 </li>
 <li>
 Other duties consistent with the position as assigned from time to time.
 </li>
 <li>
 Assist with tracking vendor quality metrics; notify QA management of any performance issues.
 </li>
 <li>
 Assist with preparation, update, review, and routing of Arrowhead procedural documents.
 </li>
 <li>
 Draft, review, and approve standard operating procedures (SOP) and work instructions (WI) as needed.
 </li>
 <li>
 Assist with QA duties as needed.
 </li>
 </ul>
 
 
 Requirements
 
 
 <ul>
 <li>
 8 years of quality assurance experience in a pharmaceutical development company and/or contract manufacturing organization.
 </li>
 <li>
 BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
 </li>
 <li>
 Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
 </li>
 <li>
 Excellent written and verbal communication skills and ability to communicate with internal and external parties.
 </li>
 <li>
 Highly motivated team player willing to contribute to a growing pharmaceutical organization.
 </li>
 <li>
 Ability to work independently with minimal supervision and as well as manage priorities within a fast-paced environment.
 </li>
 <li>
 A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead
 </li>
 </ul>
 
 
 Preferred
 
 {{:}}&nbsp;
 
 <ul>
 <li>
 Previous experience with quality systems supporting drug-device combination products per 21 CFR Part 3 and medical devices QSR per 21 CFR Part 820/ISO 13485 is preferred.
 </li>
 <li>
 Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and SmartSheet.
 </li>
 </ul>
 
 Wisconsin pay range {{:}} $90,000 USD - $110,000 USD
 
 
 Arrowhead provides competitive salaries and an excellent benefit package.&nbsp;&nbsp;&nbsp;
 
 
 All applicants must have authorization to work in the US for a company.&nbsp;&nbsp;&nbsp;
 
 
 California Applicant Privacy Policy
 
</div>

Senior Specialist, Quality Assurance

<div>
 
 Arrowhead Pharmaceuticals, Inc. (Nasdaq{{:}}&nbsp; ARWR) 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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead&rsquo;s RNAi-based therapeutics leverage this natural pathway of gene silencing.
 
 
 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 depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
 
 
 Arrowhead&rsquo;s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; San Diego, CA, and a state of the art manufacturing facility in Verona, WI.&nbsp; Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.&nbsp;
 
 
 
 The Position
 
 
 
 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.&nbsp; A key function of the position will involve review of manufacturing batch records, analytical data and reports, and associated documents within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments.
 
 
 
 Responsibilities
 
 
 <ul>
 <li>
 Interact with representatives from other departments, including manufacturing, QC, and Analytical Development, to obtain the necessary information for review of documentation.
 </li>
 <li>
 Review and approve analytical testing data and final reports from internal and external sources with minimal supervision.
 </li>
 <li>
 Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
 </li>
 <li>
 Perform room releases as required.
 </li>
 <li>
 Perform QA on the floor as required.
 </li>
 <li>
 Assist with investigations and deviations as appropriate with minimal supervision.
 </li>
 <li>
 Organization and control of project related documentation.
 </li>
 <li>
 Issue, review, and reconcile controlled forms.
 </li>
 <li>
 Review, verify, and reconcile labels.
 </li>
 <li>
 Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
 </li>
 <li>
 Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
 </li>
 <li>
 Assist with Good Documentation Practices, GMP, and data integrity training as needed.
 </li>
 <li>
 Additional duties as assigned.
 </li>
 </ul>
 
 
 Requirements
 
 
 <ul>
 <li>
 BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred.
 </li>
 <li>
 3 years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment
 </li>
 <li>
 Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
 </li>
 </ul>
 
 
 Preferred
 
 {{:}}&nbsp;
 
 <ul>
 <li>
 Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15).
 </li>
 <li>
 Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
 </li>
 <li>
 Prior experience with use of an electronic document management system in a regulated environment
 </li>
 </ul>
 
 Wisconsin pay range {{:}} $70,000 USD - $85,000 USD
 
 
 Arrowhead provides competitive salaries and an excellent benefit package.&nbsp;&nbsp;&nbsp;
 
 
 All applicants must have authorization to work in the US for a company.&nbsp;&nbsp;&nbsp;
 
 
 California Applicant Privacy Policy
 
</div>

Specialist II, Internal Quality Assurance

Join Arrowhead Pharmaceuticals and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Arrowhead Pharmaceuticals

About Company

Senior Specialist, Quality Assurance

Specialist II, Internal Quality Assurance