Quality manager jobs in Fayetteville, NC - 74 jobs

This position for Quality Management Systems (QMS) will ensure compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards in a warehouse environment specializing in clinical trial supplies. This role involves implementing, monitoring, and enhancing quality systems to maintain regulatory compliance and ensure operational excellence. Essential Duties and Responsibilities: Manage and oversee the QMS processes, including documentation, control, and implementation of policies and procedures in compliance with GDP, 21 CFR, and industry standards. Conduct routine internal & external audits of warehouse operations to ensure adherence to quality guidelines, regulatory requirements, and standard operating procedures (SOPs). Coordinate and manage deviation investigations, CAPA (Corrective and Preventive Actions), change control processes and Risk Assessments. Ensure Vendor/Customer Verification & Qualification on timely basis also should do audit if required on site of partners site. Accurate documentation check for the each transaction been carried out for the inbound and outbound by the operation team. Ensure accuracy and effective maintenance of the eQMS portal for all quality-related documentation and activities. Reviewing and Authorizing Quality related documents and agreements. Prepare and review quality documentation such as SOPs using eQMS portal, validation protocols, and training records to ensure they meet regulatory and organizational standards. Support regulatory inspections, internal audits, and customer audits by providing necessary documentation and ensuring compliance readiness. Monitor and evaluate the effectiveness of QMS processes through metrics and reporting, identifying areas for improvement. Conduct training sessions for staff on QMS policies, GDP requirements, and regulatory compliance. Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory affairs, to address quality-related issues and implement improvements. Training the operation team personnel in warehouse. Stay updated on evolving regulatory requirements and incorporate changes into QMS practices. Yearly review on the SOPs if any changes need to be made and upgrade the processes. All documents record should be kept in controlled and secured manner. Work Experience Qualifications: Proven 5+ years of work experience in QMS role within the Pharmaceutical Industry. Result driven orientation having solid customer service attitude with excellent negotiation skills. Previous experience in SAP & MS Office will be an added advantage Must have keen attention to detail and possess proper phone and email etiquette. Ability to stay organized while effectively prioritizing multiple projects at once. High attention to detail when completing projects. Person should be in position to travel for meetings and exhibitions and events. Strong time management skills to complete projects by deadlines. Self-motivated individual who takes ownership of their projects. Administrative skills (MS Office and Google Workspace are required). Maintain excellent verbal, writing, and language skills.

Since 1869 we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Michael Angelo's, Pace, Pacific Foods, Prego, Rao's Homemade, Swanson, and V8. In our Snacks division, we have brands like Cape Cod, Goldfish, Kettle Brand, Lance, Late July, Pepperidge Farm, Snack Factory, and Snyder's of Hanover. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our "Campbell's Cares" program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees. How you will make history here… Responsible for managing the plant Quality Assurance Soup Laboratories including Chemistry Lab and Microbiological Lab. Also, in conjunction with Quality Systems Manager, Logistics, Operations and R/D, coordinate releases of products, startups of new and reformulated products, supplier and incoming materials COA's, and Noncompliance's. Manage laboratory data and coordinate resolution of specification issues with materials and products. What You Will Do As a Quality Assurance Laboratory Manager, you will play a critical role in ensuring product integrity and compliance throughout the manufacturing process. Your responsibilities will include: * Product Start-Ups: * Coordinate test runs and new product/reformulation start-ups in collaboration with Plant Operations, R&D, and Quality teams. * Report outcomes and recommend next steps to management. * Ensure new products meet specifications and compliance standards, and lead corrective action plans when issues arise. * Specifications Compliance: * Oversee product sampling schedules and ensure adherence to food safety and quality requirements. * Maintain and analyze quality data using MES, Zarpac, Historian, Power BI, and other tools. * Supervise lab technicians, troubleshoot out-of-spec results, and ensure daily quality panels are completed accurately. * Supplier Quality: * Manage supplier quality monitoring programs, including ingredient sampling and non-conformance reporting. * Collaborate with Purchasing and Supply Quality teams to resolve supplier issues and maintain compliance. * Quality Department Support & Product Release: * Support audits, commercialization, mock recalls, and operational excellence initiatives. * Ensure timely product releases, including set-asides and incubated products, while maintaining compliance with SAP, WMS, and related systems. Who You Will Work With You'll collaborate cross-functionally with Operations, Maintenance, Procurement, R&D, Engineering, and corporate partners. This role requires strong coordination with WHQ Quality Assurance and Business Quality teams to resolve issues quickly and effectively. You'll also serve as a resource for supplier quality concerns and work closely with Purchasing for inspections and evaluations. What Sets Our Team Apart Our team is passionate about innovation and quality excellence. We don't just maintain standards-we continuously improve them. You'll join a collaborative environment where your expertise drives impactful decisions, ensuring that every product meets the highest standards of safety, taste, and consistency. The Future of Our Business At Campbell's, we're committed to shaping the future of food through innovation, sustainability, and uncompromising quality. As consumer expectations evolve, our QA team plays a pivotal role in delivering products that delight and nourish. Your work will directly influence new product launches and help us stay ahead in a competitive market. What you bring to the table… * Bachelor's degree (Minimum Qualification) * 3 years of experience in the food industry with demonstrated experience/achievements in Quality Assurance or laboratory practices. (Minimum Qualification) It would be great to have… * Bachelor of Science degree in food science, biology, microbiology or a related technical field * HACCP and/or PCQI certified preferred. * Proven strengths and in-depth knowledge of computer-based systems for management of labs and lab quality data. Strong computer skills and background in food safety, microbiology and food science is needed. * Ability to evaluate lab and specifications programs under their responsibility for effectiveness, accuracy, and adequacy. * Ability to partner with many diverse groups including Plant Operations, Supply Chain, Purchasing, and other technical organizations/associations to effectively manage issues and operational savings opportunities within supplier quality management. * Strong written and verbal communication skills with experience in auditing and training a diverse work group. Compensation and Benefits: The target base salary range for this full-time, salaried position is between $89,900-$129,300 Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package. The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.

Abacus Technology is seeking a Quality Assurance Manager to develop, implement, and maintain quality assurance (QA) standards and processes for telecommunications operations at Fort Bragg. This is a full-time position. Responsibilities Review requirements and support the planning and design for telecommunications projects. Conduct site visits and inspect network installation and maintenance projects. Recommend improvements to meet DoD, Army, and industry best practices and standards. Develop and maintain quality assurance standards and processes for telecommunications deliverables. Conduct formal and informal reviews at pre-determined project milestones. Perform root cause analysis (RCA) to identify issues, track trends, and implement corrective actions. Manage quality improvement activities, including problem management, risk mitigation, and continuous process optimization. Prepare quality assurance reports, compliance documentation, and performance evaluations for leadership review. Qualifications 3+ years experience in quality assurance for IT and telecommunications programs. Bachelor's degree in a related field desired. Must be BICSI Technician certified. Experience conducting audits, root cause analysis, and corrective action planning. Proficient in developing QA metrics, tracking performance, and implementing process improvements. Able to conduct formal and informal reviews of project deliverables to ensure quality compliance. Proficient with quality management systems (QMS), risk assessments, and process auditing methodologies. Able to interact professionally with all levels of an organization. Must be a US citizen and hold a current Secret clearance. Applicants selected will be subject to a U.S. government security investigation and must meet eligibility requirements for access to classified information. EOE/M/F/Vet/Disabled

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities Acts as a key advocate for quality excellence across all levels of the organization Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network Actively participates in cross-functional initiatives to align global quality strategies Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities Performs other duties, as assigned Minimum Requirements: • Bachelor's degree in engineering, life sciences with 13+ years of related experience OR • Master's degree in engineering, life sciences with 11+ years of related experience OR • Ph.D. in engineering, life sciences with 9+ years of related experience • 10+ years of people management, leadership, and team management experience • Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility. • Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. • Experience collaborating and interacting with a global team. • Training and/or familiarity with Quality Risk Management principles Preferred Requirements: • 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering) • Strong track record of driving operational excellence • Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support. Management Responsibilities Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence. Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement. Establish and monitor performance objectives, providing feedback and coaching to drive team development. Identify business and quality risks, escalating appropriately and in a timely manner. Technical Responsibilities Provide continuous quality improvement oversight to regulated processes, practices, and documentation. Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements. Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues. Work cross-functionally with process teams for metrics reviews, operational support, and deviation management. Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance. Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings. Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines. Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes. Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions. Minimum Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, or related field. 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role. Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements. Demonstrated attention to detail and ability to maintain quality systems. Previous experience leading or working effectively with a cross-functional group. Demonstrated excellent interpersonal, written and oral communication skills. Demonstrated strong technical aptitude and ability to train and mentor others. Demonstrated decision making and problem-solving skills. Demonstrated ability to organize and prioritize multiple tasks. Additional Preferences: Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc. Previous experience with Manufacturing Execution Systems and electronic batch release. CQM, CQE, or CQA certification from the American Society for Quality (ASQ). Previous experience with Trackwise, Veeva, MODA. Additional Information: The schedule for this position is 12 hours day-shift (2-2-3) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $94,500 - $138,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Role and Responsibilities The Quality Manager is responsible for developing, implementing, and maintaining the organization's Quality Management System (QMS) to ensure products and processes meet internal standards, customer expectations, and regulatory requirements. This role leads to quality assurance, quality control, continuous improvement initiatives, and serves as the primary contact for audits and customer quality issues. Main tasks Proof testing round-slings Failure testing round-slings Commodity product testing/inspecting. Yarn tensile testing Sling in process testing Random proof or failure testing WIP webbing testing Maintain and improve the QMS in alignment with ISO 9001 (and other applicable standards). Ensure documented processes, procedures, and work instructions are current and followed. Prepare quality reports. Additional projects assigned. Work with suppliers to resolve incoming quality issues and develop supplier quality metrics. Lead improvement projects using Lean, Six Sigma, and problem-solving tools. Analyze data trends (scrap, rework, returns, warranty claims) and drive reduction plans. Qualifications 2-year degree or greater required in related field. Solid understanding of test equipment. Minimum of 2 years of Quality Assurance experience. Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions. Must have strong Microsoft Excel skills with intermediate or greater level of experience. Ability to lift and/or move up to 50 pounds occasionally. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Demonstrated ability to work independently with minimal supervision. Demonstrated ability to analyze and interpret information. Ability to walk and stand in production areas without assistance. And other Duties Assigned. The job description doesn't imply an employment contract, nor is it intended to include every duty, task or instruction for which the employee is responsible.

Job Description Quality Control Manager (QCM), Federal Construction Columbus, GA Full-Time, Onsite, Federal Project Assignment About the Role We are seeking an experienced Quality Control Manager (QCM) to support federal government construction projects in the Columbus, GA area. This role is critical to ensuring all construction activities comply with contract documents, USACE standards, EM 385 requirements, and applicable federal regulations. The QCM will serve as the primary point of contact for quality-related matters and will work closely with the Project Manager, Superintendent, subcontractors, and government representatives. Key Responsibilities Develop, implement, and manage the Contractor Quality Control (CQC) Plan in accordance with USACE and DoD requirements Conduct and document the Three-Phase Control Process: Preparatory, Initial, and Follow-Up Inspections Review and manage submittals, RFIs, and quality documentation for compliance with contract specifications Perform daily quality control inspections across all phases of construction including civil, structural, architectural, and MEP work Prepare and submit daily QC reports, inspection logs, deficiency tracking, and corrective action documentation Coordinate and lead preparatory meetings, initial inspections, and quality coordination meetings Interface directly with Government QA personnel and participate in inspections, audits, and site walks Ensure work is executed in accordance with approved plans, specifications, and safety standards Track deficiencies, oversee corrective actions, and verify closeout compliance Support project closeout activities including punch lists, as-builts, and final inspections What We're Looking For Minimum 5 years of experience as a Quality Control Manager on federal construction projects Demonstrated experience working on USACE, NAVFAC, or other DoD projects Strong knowledge of federal construction standards, quality processes, and documentation requirements Experience coordinating with government inspectors and contracting officers Ability to manage multiple features of work and maintain organized quality records Strong communication skills and attention to detail Required Certifications & Qualifications USACE Construction Quality Management (CQM) for Contractors Certification OSHA 30-Hour Construction Safety Certification Working knowledge of EM 385-1-1 safety standards Ability to pass federal background requirements and site access credentials Valid driver's license Why Join Us? Work on stable, long-term federal government construction projects Clear scope, defined quality standards, and structured project environments Opportunity to work with experienced federal project teams Competitive compensation based on experience and certifications Total Rewards & Benefits Competitive salary or hourly compensation based on experience Per diem, lodging, and travel support if applicable Health insurance options and paid time off Consistent federal project pipeline Apply Today Qualified candidates are encouraged to apply to be considered for current and upcoming federal construction projects in the Columbus, GA area. Confidential inquiries are welcome.

Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, and automotive powering a high-technology future. Vulcan Elements is building a team of ambitious professionals committed to Mission Focus, Technical Excellence and Transparency. As the Director of Quality, you will architect and lead the Total Quality Management (TQM) strategy for our domestic magnet production. You will be responsible for building a world-class quality organization from the ground up, ensuring that our products meet stringent specifications while supporting a rapid manufacturing ramp-up. Responsibilities Design, implement, and maintain a robust quality management system (QMS) compliant with AS9100 (Aerospace), IATF 16949 (Automotive), and/or ISO 9001 standards. Build and scale the quality team, including quality engineering, inspection, and laboratory functions, to support full-scale manufacturing Establish rigorous Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) programs to drive continuous improvement. Develop and oversee a supplier quality management program to ensure the integrity of the raw material supply chain. Partner with Engineering, Operations, and Data Informatics to integrate automated quality inspection and data collection into the production workflow. In collaboration with the Materials & Data Informatics team, oversee the selection, operation, and maintenance of advanced metrology equipment and laboratory testing for magnet performance and material characterization in the production facility. Responsibilities and tasks outlined are not exhaustive and may change as determined by the needs of the business Qualifications 8+ years experience in quality engineering or operations, ideally within powder metallurgy, advanced materials, rare-earth magnet manufacturing, automotive, battery, or similar high volume manufacturing environments 4+ years demonstrated leadership experience in a quality or manufacturing organization Experience with QMS implementation conforming to ISO 9001, AS9100, IATF 16959, or similar Bachelors Degree in Engineering, Materials Science and Engineering, or technical field Must be a U.S. Person due to required access to U.S. export-controlled information or facilities.

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment * Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements * Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards * Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation * Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary * Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements * Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle * Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed * Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards * Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness * Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities * Acts as a key advocate for quality excellence across all levels of the organization * Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility * Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. * Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network * Actively participates in cross-functional initiatives to align global quality strategies * Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations * Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments * Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines * Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management * Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success * Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies * Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities * Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in engineering, life sciences with 13+ years of related experience OR• Master's degree in engineering, life sciences with 11+ years of related experience OR• Ph.D. in engineering, life sciences with 9+ years of related experience• 10+ years of people management, leadership, and team management experience• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.• Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines.• Experience collaborating and interacting with a global team. * Training and/or familiarity with Quality Risk Management principles Preferred Requirements: * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering)• Strong track record of driving operational excellence• Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. What You Will Achieve In this role, you will: Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues Additional Qualifications/Responsibilities Here Is What You Need (Minimum Requirements) BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience Substantial experience in pharmaceutical manufacturing and quality control Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects Knowledge of regulations related to vendor management programs and other industry quality systems Strong critical thinking skills and a proactive approach Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms Bonus Points If You Have (Preferred Requirements) Experience in Quality Systems in pharmaceutical, medical device, or combination product industry Knowledge or exposure to data science Strong leadership and team management skills Ability to work under pressure and meet tight deadlines Ability to influence and negotiate with stakeholders Experience in conducting internal audits and supporting regulatory inspections Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use Relocation support available Work Location Assignment: On Premise The annual base salary for this position ranges from $99,200.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Job DescriptionDescription: For over twenty years, Cinterra has provided specialized electrical utility and solar construction services to support some of the nation's leading contractors, private industry and public utilities. Our commitment to quality and customer satisfaction is only rivaled by one of the highest safety ratings in the industry. The services we provide help to bring electric power and renewable energy sources to millions. Come join our team today! Position Summary: The Quality Control Manager is responsible for successfully overseeing, managing and supporting the Quality Control Program across multiple locations. They play a crucial role in ensuring that field quality activities are executed efficiently, safely, and in compliance with the established Cinterra QMS. The Quality Control Manager coordinates with the Project Management Team and other departments to achieve operational objectives and deliver high-quality services to our clients or customers. With authoritative decision-making this role's recommendations have a significant impact on business line quality policies and programs. This role may supervise the work of assigned quality personnel as needed. Essential Duties & Responsibilities: Provide leadership and support to the assigned regional site personnel to meet and exceed customer requirements. Implement and supervise technical quality (i.e., adherence to client, regulatory agency, and company requirements), and help to maintain harmonious client relations. Key Point of Contact for escalation of quality related issues which cannot be addressed at the local level. Serve as project Quality Manager on projects if necessary. Ensure Standard Operating Procedures (SOP), Method of Procedures (MOP), and QC checklists are being utilized Manage quality control inspections. Responsible for quality performance of assigned region including statistical reporting, auditing, continuous improvement, corrective action/root cause analysis and employee training/competency compliance. Ensure that all QC records are accurate, uniform, and adequately maintained prior to submission to the customer. Work with QC Supervisors to review and understand contract requirements related to quality control. Review site-specific QC program for conformity to Company QC Program as well as compliance with contract requirements and system design. Remain aware of quality related developments at all site locations, identifying risks and opportunities for improvement. Review project design, drawings, and specifications. Other duties as assigned. Requirements: 4+ years in construction, with 2+ years minimum in utility scale solar in a quality manager or equivalent role. Proven experience in field quality/operations management or a similar role. Strong leadership and team management skills. NFPA 70E Certification - preferred. Experience with electrical testing procedures and digital documentation. Familiar with AHJ standards and NEC code. Understands how to read and interpret plans, specifications, and equipment standards. Familiarity with construction means and methods applicable to utility scale solar and substation installations. Excellent problem-solving and decision-making abilities. Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders. Familiarity with safety regulations and compliance requirements in the relevant industry. Good computer skills including proficiency in industry standard software programs and proficiency in using technology and software systems for quality management. Effective communication and interpersonal skills. Ability to work under pressure and in dynamic field environments. Willingness to frequently travel and work outside of regular business hours. Possess a valid US driver's license. Regular scheduled and unscheduled travel to projects, as performance of projects dictate. Physical Demands and Work Environment: This job regularly operates in a field environment. This role routinely requires extended periods of standing, walking, bending, squatting, and lifting. Also, working in inclement weather conditions, such as extreme heat, extreme cold, rain, ice, snow, and wind. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. This position is physically active, with lifting required. Must be able to bend and lift and carry up to 50 pounds. Cinterra provides equal employment opportunities without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

it's what's inside that counts _______________________________ There's more to CMC than our products and the buildings, structures, and roads they go into. At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills and offices that make us who we are as a company. Our success comes from finding, retaining, and supporting the highest quality talent by offering: * Day 1 Benefits Coverage with low cost Medical, Vision, Dental * Day 1 Paid-time Off and Vacation * 4.5% Company Match 401(k) plan * $500 Annual Company-paid Lifestyle Benefit * Competitive Compensation and Bonuses * Company-paid Life and Disability Insurance * Employee Stock Purchase Plan * Training and Advancement Opportunities Why This Job CMC provides an excellent opportunity to learn the steel, construction reinforcement and ground stabilization industries and to grow in your career. Whether you will spend your day brainstorming in an office cubicle, operating a crane, running manufacturing equipment or troubleshooting technical obstacles, at CMC, you'll get the training and support from your team that you need to excel in your role and reach your full potential. What You'll Do * Develop, implement, and manage the plant's quality control program. * Supervise and coach QC Technicians, including scheduling, training, and performance management. * Ensure all raw materials, in-process, and finished products meet company and customer specifications. * Maintain and enforce compliance with industry standards (ACI, ASTM, DOT), codes, and safety regulations. * Review and approve QC reports, inspection results, and documentation. * Collaborate with production, engineering, and management teams to resolve quality issues. * Identify trends in quality data and implement corrective or preventive actions. * Maintain laboratory equipment, tools, and testing areas to ensure proper function. * Lead continuous improvement initiatives to enhance product quality and process efficiency. What You'll Need * Strong knowledge of concrete materials, precast concrete production, and quality standards. * Experience with ACI, ASTM, and state/federal regulations for concrete and precast products. * Leadership and team management skills, including training, mentoring, and performance evaluation. * Strong analytical and problem-solving skills to identify and resolve quality issues. * Excellent written and verbal communication skills for reporting and collaboration. * Ability to manage multiple projects, prioritize tasks, and meet deadlines. * Proficiency in documentation, recordkeeping, and basic computer software. Your Education * High school diploma or GED required; relevant technical or vocational training preferred. We are CMC, a Fortune 500 company at the leading edge of our industry. Our construction reinforcement and steel products have supported construction projects and structures around the world. The secret to our success? We've built our legacy by assembling a team of innovators and doers to tackle some of the most challenging construction reinforcement problems facing our world for more than 100 years - and we're just getting started. If you're ready to join a team working to make our industry more sustainable, support the bridges, roadways, buildings and infrastructure that connects our communities, and do meaningful work, you're ready to join CMC. Apply today and start moving your career - and our world - forward. Let's build a better world! CMC is committed to providing equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, age, physical or mental disability, national origin, citizenship, military or veteran status, sexual orientation, gender identity and/or expression, genetic information, or other status protected by federal, state or local law. From Fortune Magazine. 2025 Fortune Media IP Limited. All rights reserved. Used under license. Current Employee? Click Here to Apply. Current Employees Apply Click here to apply. Nearest Major Market: Fayetteville

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Quality Assurance Senior Manager, Plant QA** **What you will do** Let's do this. Let's change the world. As a Quality Assurance Senior Manager, you will lead our Drug Substance Plant QA (PQA) team and will serve as the Quality Leader for Good Manufacturing Practices (GMP) Operations within the Drug Substance Commercial Manufacturing facility. The QA Senior Manager PQA will play a key role in the Quality Assurance team, focused on building a strong team and establishing efficient Plant Quality processes. The QA Senior Manager will lead a team of QA staff, collaborate with cross-functional partners, and provide QA leadership and oversight in support of the operational team's key responsibilities. Your team will work closely with the manufacturing team to assure product is produced according to quality standards and in alignment with the regulatory filing. The QA Senior Manager will report to the Director of Quality Assurance for Drug Substance (DS) and be a member of the DS QA team that coordinates and contributes to serving Amgen patients via DS supply across all the Amgen commercial facilities. As a member of this leadership team and as a member of the cross functional leadership teams serving Drug Substance supply, the QA Senior Manager will contribute to fostering and further developing the culture of Safety and Quality at ANC. **The job responsibilities will include but not be limited to:** + **Staff Management** - Leads a culture of safety and quality. Maintains the physical and psychological safety of self and others. Prioritizes professional development and drives continuous improvement mindset of direct reports. Performs staff recruitment and selection, training, oversight, development and performance evaluations according to Amgen's talent management program. Assures compliance with cGMP training requirements for staff. + **Quality Oversight** - Ensures the Quality Management System processes are implemented and maintained in accordance with established procedures. Collaborate with the manufacturing team to ensure product is produced according to quality standards and in alignment with the regulatory filing. Provides direction and decision making for Quality system records and reports such as batch records, investigations, CAPAs, Change Control. Reviews and approves records and reports. May serve as record or report owner. Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Drug Substance is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks. Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. + **Quality Leadership -** Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, performed, and continuously improved in accordance with established procedures and applicable regulations. Lead and/or participate in audit and inspection activities to ensure compliance with commitments made to Regulatory Authorities and cGMPs. May provide leadership and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Change Review Board, Risk Management. Alerts senior management of significant quality, compliance, supply and safety risks. + **Continuous Improvement** - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Amgen's Operational Excellence program to develop stronger capabilities in continuous improvement. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications. **Basic Qualifications:** + High school diploma / GED and 12 years of Quality or Operations experience OR + Associates degree and 10 years of Quality or Operations experience OR + Bachelor's degree and 8 years of Quality or Operations experience OR + Master's degree and 6 years of Quality or Operations experience OR + Doctorate degree and 2 years of Quality or Operations experience + AND - In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above **Preferred Qualifications:** + Educational background in Life Science or Engineering. + Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations. + Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Product Disposition + Strong experience working in a GMP environment. + Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian) + Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations. + Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations. + Experience participating in, managing, and responding to health authority inspections, partner and corporate audits. + Demonstrated leadership in multiple functional areas. + Able to drive process improvement within area of responsibility. + Familiarity with basic project management tools and lean + Strong organizational skills, including ability to follow assignments through to completion. + Excellent written and verbal communication skills. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Performs duties associated with Quality (including but not limited to): (50%) Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR). Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation. In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations. Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%) Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%) Maintain certification and perform all required duties of Lead Technician. (10%) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience. Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician). Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment. Effective communication, organizational, and technical/problem-solving skills. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Ability to multi-task and work as a team player. Innovation Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs. Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required Desired: Associate or Bachelor's degree preferred ADDITIONAL INFORMATION FLSA Classification (US) - Non-Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NC - Fayetteville - Morgan U.S. Hourly Wage Range: $20.00 - $27.50 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NC - Fayetteville - Morgan Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No

Linde Gas & Equipment Inc. Site Quality Coordinator Linde Gas & Equipment Inc. is seeking a responsible Site Quality Coordinator to join our team! Influential individual contributor that leads the management and development of the quality activities for all products manufactured at the RTP electronic gases facility. This position is responsible for managing all quality related programs, initiatives, and reporting requirements for this site. This position works closely with all individuals in the production facility across various departments and works closely with plant manager, providing leadership in this functional area with daily onsite presence. Position is key to Linde's ISO Certification, customer complaints responses, operational quality metrics and management of MRB. This position reports to the EG&SP Operational Quality Manager. This is a great opportunity to start your career at a leading global industrial gases company! What we offer you! * Competitive compensation * Comprehensive benefit plan (medical, dental, vision and more) * 401(k) retirement savings plan * Paid time off (vacation, holidays, PTO) * Employee discount programs * Career growth opportunities * Additional compensation may vary depending on the position and organizational level What you will be doing: * Lead Critical Investigations: Serve as the primary investigator for customer reported issues, ensuring thorough root cause analysis, clear communication, and strong corrective/preventive action implementation. * Strengthen Audit Excellence: Lead internal and external quality audits, maintaining compliance with ISO 9001, corporate standards, and customer specific requirements while driving continuous improvement. * Ensure Site-Level Compliance: Manage investigations, risk assessments, and change control processes to support operational continuity and regulatory alignment across the site. * Collaborate Across Regions: Partner with international quality teams-such as TMM Ireland-to align supply chain quality processes and enable consistent global execution. * Facilitate Quality Leadership Processes: Lead the site's Quality Leadership Meetings, fulfilling ISO 9001 management review expectations and supporting customer-facing requirements. * Support Customer Audit Readiness: Coordinate customer audits, provide timely documentation and follow up, and ensure sustained customer approval status. * Drive Shared Learning: Participate in enterprise-wide best practice exchanges, helping deploy systemic corrective actions and standardized processes across sites. * Enable Data-Driven Quality Management: Support the site's trend analysis leads with quality data, contributing to early risk identification and meeting the expectations of high-reliability industries such as semiconductors. * Maintain Quality System Integrity: Ensure ongoing compliance with ISO standards, internal quality system requirements, and evolving semiconductor customer expectations. * Protect Operational Continuity: Provide essential on-site quality support that safeguards production stability, customer trust, and audit readiness. This role requires access to information and products subject to U.S. export control laws (ITAR/EAR). Consistent with those laws, candidates must meet the definition of a "U.S. person"-i.e., a U.S. citizen, U.S. lawful permanent resident (Green Card holder), or an individual granted protected status (such as refugee or asylee) under 8 U.S.C. § 1324b(a)(3). What makes you great: * Associate degree preferred in an engineering, quality, or science discipline * Minimum of 3 year's experience in quality, engineering, or operations function in the Electronics gases industry. * Proven track record in managing quality assurance systems. * Skilled in analytical software and data management systems to support quality programs. * Dashboard programming experience (bonus but not required). * Power Apps experience (bonus but not required). * Demonstrated adaptability - able to adjust priorities and responsibilities as business needs evolve to keep quality aligned with organizational goals. * Experienced in leading cross-functional teams. * Strong communication and presentation skills across cultures and organizational levels. * Experience with electronic gases and technical products, valve and packing knowledge. Why you will enjoy working with us Linde is a leading global industrial gases and engineering company with 2024 sales of $33 billion. Linde Gas & Equipment Inc. (LG&E) is part of the largest Welding, Industrial, Medical, and Specialty Gases companies in the U.S. We carry a comprehensive selection of industrial gases, such as oxygen, nitrogen, argon, and carbon dioxide, etc. LG&E has an extensive network of production plants, retail stores, distribution centers, and customer service locations with a focus on making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful by helping to sustain and protect our planet. For more information about the company, please visit our website. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, pregnancy, sexual orientation, gender identity or expression, or any other reason prohibited by applicable law. #LI-IS1

Since 1869, we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao's Homemade, Snack Factory, Snyder's of Hanover. Swanson, and V8. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our “Campbell's Cares” program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees. How you will make history here… Responsible for managing the plant Quality Assurance Soup Laboratories including Chemistry Lab and Microbiological Lab. Also, in conjunction with Quality Systems Manager, Logistics, Operations and R/D, coordinate releases of products, startups of new and reformulated products, supplier and incoming materials COA's, and Noncompliance's. Manage laboratory data and coordinate resolution of specification issues with materials and products. What You Will Do As a Quality Assurance Laboratory Manager, you will play a critical role in ensuring product integrity and compliance throughout the manufacturing process. Your responsibilities will include: Product Start-Ups: Coordinate test runs and new product/reformulation start-ups in collaboration with Plant Operations, R&D, and Quality teams. Report outcomes and recommend next steps to management. Ensure new products meet specifications and compliance standards, and lead corrective action plans when issues arise. Specifications Compliance: Oversee product sampling schedules and ensure adherence to food safety and quality requirements. Maintain and analyze quality data using MES, Zarpac, Historian, Power BI, and other tools. Supervise lab technicians, troubleshoot out-of-spec results, and ensure daily quality panels are completed accurately. Supplier Quality: Manage supplier quality monitoring programs, including ingredient sampling and non-conformance reporting. Collaborate with Purchasing and Supply Quality teams to resolve supplier issues and maintain compliance. Quality Department Support & Product Release: Support audits, commercialization, mock recalls, and operational excellence initiatives. Ensure timely product releases, including set-asides and incubated products, while maintaining compliance with SAP, WMS, and related systems. Who You Will Work With You'll collaborate cross-functionally with Operations, Maintenance, Procurement, R&D, Engineering, and corporate partners. This role requires strong coordination with WHQ Quality Assurance and Business Quality teams to resolve issues quickly and effectively. You'll also serve as a resource for supplier quality concerns and work closely with Purchasing for inspections and evaluations. What Sets Our Team Apart Our team is passionate about innovation and quality excellence. We don't just maintain standards-we continuously improve them. You'll join a collaborative environment where your expertise drives impactful decisions, ensuring that every product meets the highest standards of safety, taste, and consistency. The Future of Our Business At Campbell's, we're committed to shaping the future of food through innovation, sustainability, and uncompromising quality. As consumer expectations evolve, our QA team plays a pivotal role in delivering products that delight and nourish. Your work will directly influence new product launches and help us stay ahead in a competitive market. What you bring to the table… Bachelor's degree (Minimum Qualification) 3 years of experience in the food industry with demonstrated experience/achievements in Quality Assurance or laboratory practices. (Minimum Qualification) It would be great to have… Bachelor of Science degree in food science, biology, microbiology or a related technical field HACCP and/or PCQI certified preferred. Proven strengths and in-depth knowledge of computer-based systems for management of labs and lab quality data. Strong computer skills and background in food safety, microbiology and food science is needed. Ability to evaluate lab and specifications programs under their responsibility for effectiveness, accuracy, and adequacy. Ability to partner with many diverse groups including Plant Operations, Supply Chain, Purchasing, and other technical organizations/associations to effectively manage issues and operational savings opportunities within supplier quality management. Strong written and verbal communication skills with experience in auditing and training a diverse work group. Compensation and Benefits: The target base salary range for this full-time, salaried position is between $89,900-$129,300 Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package. The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Manager/Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support. Management Responsibilities Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence. Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement. Establish and monitor performance objectives, providing feedback and coaching to drive team development. Identify business and quality risks, escalating appropriately and in a timely manner. Technical Responsibilities Provide continuous quality improvement oversight to regulated processes, practices, and documentation. Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements. Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues. Work cross-functionally with process teams for metrics reviews, operational support, and deviation management. Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance. Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings. Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines. Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes. Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions. Minimum Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, or related field. 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role. Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements. Demonstrated attention to detail and ability to maintain quality systems. Previous experience leading or working effectively with a cross-functional group. Demonstrated excellent interpersonal, written and oral communication skills. Demonstrated strong technical aptitude and ability to train and mentor others. Demonstrated decision making and problem-solving skills. Demonstrated ability to organize and prioritize multiple tasks. Additional Preferences: Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc. Previous experience with Manufacturing Execution Systems and electronic batch release. CQM, CQE, or CQA certification from the American Society for Quality (ASQ). Previous experience with Trackwise, Veeva, MODA. Additional Information: The schedule for this position is 12 hours night-shift (2-2-3) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $94,500 - $138,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager Quality Assurance - Incoming Quality Assurance Raw Materials /Disposition What you will do Let's do this! Let's change the world! In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Specific responsibilities include but are not limited to: Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations). Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements. Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring. Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations. Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays. Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact. Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program. Represent the Quality unit during internal and external audits and regulatory inspections. Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed. Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline. Additional Qualifications/Responsibilities We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR Associate's degree and 10 years of Quality and Manufacturing support industry experience OR Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR Master's degree and 6 years of Quality and Manufacturing support industry experience OR Doctorate degree and 2 years of Quality and Manufacturing support industry experience Preferred Qualifications: Educational background in Life Science and/or Engineering Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems. In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice. Hands-on experience with Disposition, Incoming, and Quality Systems-particularly investigations, corrective actions, and audit readiness. Experience managing and interacting with regulatory and internal auditors. Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills. Effective risk management, negotiation, and cross-functional collaboration abilities. Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish. Salary Range 154,692.00 USD - 188,725.00 USD

Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager, Quality Control Microbiology What you will do Let's do this. Let's change the world. In this vital role, you will manage the Sampling and Testing teams within the Quality Control Microbiology laboratory. This role oversees routine environmental monitoring, clean utilities' monitoring, and routine microbiological testing to support drug substance manufacturing. The Manager, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. Directly supervise Microbiology staff supporting routine Environmental monitoring and utilities monitoring sampling and testing, and production in-process and final drug substance testing. Manage the training program for sampling and testing team. Assist with planning, scheduling, and lead execution of EMPQ and Clean Utilities qualification activities to support facilities changes. Assist the Environmental Monitoring and Utilities Monitoring program owner with sampling scheduling, coordinating activities with manufacturing operations, reviewing and interpreting data, and writing trend reports. Act as Subject Matter Expert for method families and testing platforms used in the microbiology department. Work cross-functionally with Manufacturing, Analytical Sciences, Facilities & Engineering, and Quality teams to align processes with business needs. Author, revise, and review documents and reports including but not limited to: SOPs, safety assessments, trend reports, qualification/validation summary reports, microorganism assessments, and technical reports. Represent the microbiology department during agency inspections and internal audits. Work closely with the global Quality Control organization to drive standardization of testing processes and procedures. Own, manage, and participate in deviations, CAPAs, and cross functional investigations. Lead process improvement projects that may be local or global in scope. Support routine activities over the weekends and public holidays as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Manager Quality Control Microbiology we seek is a dynamic, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR Associate's degree and 10 years of Quality or Aseptic Manufacturing experience OR Bachelor's degree and 5 years of Quality or Aseptic Manufacturing experience OR Master's degree and 3 years of Quality or Aseptic Manufacturing experience OR Doctorate degree And In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Strong leadership skills, with the ability to manage multiple direct reports. Degree in Microbiology, Biology, Biochemistry, or related scientific field. Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data. Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC. Experience with equipment validation. Solid understanding of aseptic technique. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 122,421.00 USD - 142,851.00 USD