Sr. Quality Assurance Specialist-Operations

Sr. Quality Assurance Specialist-Operations Job Locations US-NJ-Warren Job ID 2024-3674 Category Quality Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. If you're a QA expert when it comes to manufacturing, Immucor has an exciting opportunity for you We are looking to hire a Sr. Quality Assurance Specialist with a background in blood banking, medical device, and/or the pharmaceutical industry. This critical role is responsible for providing quality oversight at the shop floor level to address immediate quality issues. If you've got the necessary skills and experience to excel in this role, we want to hear from you This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time . Sr. Quality Assurance Specialist (Operations) Responsibilities Job Summary The Senior Quality Assurance Specialist-Operations will support the organization by providing quality oversight of manufacturing/oprations and ensuring all applicable GMP and regulatory requirements (ex. 21 CFR Part 820 and ISO 13485) are followed. Key Accountabilities Maintain quality system compliance with ISO 13485, QSR & IVDR, including creating new/revising existing quality system documentation. Provides oversight support of the manufacturing, packaging, and laboratory operations. Areas of responsibility may change based on business needs. Perform line opening and closing QA activities in support of manufacturing operations. Review and approve incoming, in-process and final batch records (DHRs); ensure associated NCMRs/Deviations are processed per procedural requirements; maintain retain program; maintain QA inventory; perform necessary ERP transactions. Makes quality decisions (under guidance of Quality Operations Manager), including but not limited to, determination of a quality deviation, product hold, stopping operations, etc. based on the specific circumstances that could affect product quality. Performs root cause analysis and initiate/supports CAPAs for quality related concerns. Participate as an owner/team member of CAPA and Change control action items. Define, write, and implement quality procedures/forms in collaboration with quality and operations staff. Maintain knowledge as SME in quality assurance/operations and conduct training activities for new and current employees. Remain up to date with current federal and international regulations and industry trends as related to the above listed duties. Performs other duties and responsibilities as assigned Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications Minimum Knowledge & Experience required for the position: Minimum bachelor's degree in a science related field (ex. Biology, chemistry, biomedical engineering). Five (5) years or more experience in quality assurance in a medical device or pharmaceutical industry. Two (2) years or more experience in DHR/batch record review and product release. Knowledge and experience enforcing FDA and EU regulations for medical device and/or pharmaceuticals (21 CFR Part 211 or 820, ISO 13485). Sr. Quality Assurance Specialist (Operations) Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team. www.werfen.com Connect With Us Not ready to apply? Connect with us for general consideration.