13 quality analyst jobs found in Durham

Biogen Job Title: Sr. Analyst I, Material Planning About This Role: As a Sr. Analyst I in Material Planning, you will play a pivotal role in supporting manufacturing planning efforts at our RTP Pharma Manufacturing Site, focusing on both clinical and commercial programs. You will work closely with teams across Manufacturing, Warehouse, Scheduling, Quality, and Procurement to address raw material issues, manage scheduling conflicts, and ensure optimal inventory levels. Your role is integral to driving project success, as you resolve issues and report project status to both your team and management. With a keen eye on analyzing data to help reduce costs and mitigate write-offs. This position requires a balance of independent work and effective collaboration across all business areas and organizational levels. What You'll Do: Manage raw materials planning and inventory control activities, including forecasted demand, stock levels, and expiry reporting. Oversee weekly...

9th Way Insignia 9th Way Insignia is a service-disabled, veteran-owned small business bringing transformative technology to our government customers so they can achieve their missions. Our specialties include cybersecurity, cloud modernization, software development, data analytics, enterprise architecture, enterprise IT, analytics, process automation, and artificial intelligence. Learn more about 9th Way Insignia at https://9thwayinsignia.com/. Application password: Niner This position is contingent upon contract award. Professional Level Information: The Senior DBA aligns as an Engineer 2 at 9th Way Insignia. The role provides expert Oracle database engineering and operations across VESEE 2.0 modernization and sustainment, including performance engineering, data migration, and continuity of operations for the Enrollment System (ES) and consolidated legacy datasets (EDB, IVM, VistA REE). Responsibilities: Own end-to-end Oracle database performance...

Merck Job Description GENERAL SUMMARY: The Sustainability & Utility Engineer is a member of the Plant Engineering team providing direct hands on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's sustainability improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: Individual contributor...

Merck Job Description GENERAL SUMMARY: The Sustainability & Utility Engineer is a member of the Plant Engineering team providing direct hands on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's sustainability improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: Individual contributor...

Merck Job Description GENERAL SUMMARY: The Utility Engineer is a member of the Plant Engineering team providing direct hands-on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: Individual contributor role working with professional...

Merck Job Description Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products. This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations...

Merck Job Description Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products. This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations...

Merck Job Description GENERAL SUMMARY: The Utility Engineer is a member of the Plant Engineering team providing direct hands-on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: Individual contributor role working with professional...

Genesys Genesys empowers organizations of all sizes to improve loyalty and business outcomes by creating the best experiences for their customers and employees. Through Genesys Cloud, the AI-powered Experience Orchestration platform, organizations can accelerate growth by delivering empathetic, personalized experiences at scale to drive customer loyalty, workforce engagement, efficiency and operational improvements. We employ more than 6,000 people across the globe who embrace empathy and cultivate collaboration to succeed. And, while we offer great benefits and perks like larger tech companies, our employees have the independence to make a larger impact on the company and take ownership of their work. Join the team and create the future of customer experience together. AI Sales Strategy Manager Job Summary The AI Sales Strategy Manager supports the development and execution of strategies that drive the adoption of Genesys AI and Experience Orchestration solutions. This...

Biogen This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule About This Role The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities: (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval. WhatYou'llDo Ensures Product documentation and other documents supporting batch execution are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented...

Biogen About This Role: As the Director of Quality Control, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment, testing procedures. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain. What You'll Do: Lead the Pharma Site QC Operations organization - Management of...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen This is an onsite position, Monday through Friday, with occasional weekend and off-shift support required About This Role We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies. What You'll Do Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations (e.g., EU Annex 1, FDA...