12 quality assurance technician jobs found in Durham

Biogen This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Associate III has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Associate III has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The QA Associate III identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The QA Associate III performs all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. The QA Associate III...

Biogen About This Role This position is on a 12-hour rotation, Night shift on a 2, 2, 3 schedule This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions on our Large Scale Manufacturing Purification Team . The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments. What You'll Do Supervises Manufacturing Associates - observing/instructing, coaching, leading and developing staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives. Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity. Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff and...

Biogen About This Role: As the Head of Global Integrated Digital Execution & Automation Solutions, you will lead and coordinate the digital execution and automation engineering activities across capital projects, lifecycle management, and manufacturing operations. Your role will be pivotal in driving continuous improvement initiatives with a right-first-time mindset, ensuring all activities align with industry standards and Biogen's best practices. Reporting directly to the Head of Global Engineering, you will work closely with global and site functions to support Manufacturing Operations, Quality, and other key stakeholders, building global capabilities in a standardized and reliable manner. Your leadership will guide the development and governance of technical standards, propelling Biogen forward in the digital arena. You will be instrumental in fostering strategic partnerships and ensuring compliance with regulatory and safety guidelines, thereby enhancing Biogen's...

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Biogen About This Role: As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility. Your expertise in GMP activities ensures that our quality systems remain compliant with industry standards. You will lead the charge in managing site inspections, regulatory requests, and overseeing the creation and approval of GMP documents. Your ability to balance departmental workload, mentor team members, and manage key projects will significantly contribute to our team's success. This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment to quality and excellence. What You'll Do: Manage regulatory and partner inspections, ensuring timely inspection setup, support, and closure Lead inspection readiness activities, including planning and execution Process regulatory requests to support submissions and approvals...

Bug Out Benefits Start Day 1 for Full-Time Colleagues - No Waiting Period! For more information about our benefits, see below! We are proud to be a member of the Rentokil family of companies, the global leader in Pest Control and other services across more than 90 countries. We pride ourselves on being a trusted partner to many of the world's leading brands and serve consumer and business customers across multiple industries. We are extremely proud of our legacy of excellence and constantly work to fulfill our mission to "protect people, enhance lives, and preserve the planet." What do our Innovation/Utility specialists do? The primary purpose of this role is to perform the dynamic combined aspects of pest control, exclusion services, minor construction, and TAP ( T hermal A coustical P est) insulation installation allowing you to make a significant impact in the communities we serve. Responsibilities include but are not limited to the following: Pest...

Biogen This is a full time on-site position with M-F business hours About This Role The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a mannerconsistent with site and Corporate policies, cGMP, safety, environmental and humanresources policies and procedures. This individual will assist with regulatory and third party audits, aid in the development and implementation of GlobalQualitySystems, and manage Quality projects and other...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned. What You'll Do Review test data in LIMS Prepare quarterly EM/UM reports Supports testing for all qualification and study directed testing Troubleshoot complex assays Perform microbiology testing...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

Bug Out Benefits Start Day 1 for Full-Time Colleagues - No Waiting Period! For more information about our benefits, see below! We are proud to be a member of the Rentokil family of companies, the global leader in Pest Control and other services across more than 90 countries. We pride ourselves on being a trusted partner to many of the world's leading brands and serve consumer and business customers across multiple industries. We are extremely proud of our legacy of excellence and constantly work to fulfill our mission to "protect people, enhance lives, and preserve the planet." What do our Pest Control Consultants do? The primary purpose of this role is to sell the company's industry leading pest management services and products to new and existing residential customers, while maintaining a customer-focused service to grow the business. You'll be the face of our national brand to your local community, and your clients will count on you to protect their homes and their...