Quality assurance manager jobs in Fayetteville, NC - 100 jobs

Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Let's do this. Let's change the world. Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance Responsibilities: Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Oversee and provide guidance during on-the-floor analytical testing. Ensure that changes that could potentially impact product quality are assessed according to procedures. Ensure that deviations from established procedures are investigated and documented per procedures. Alert senior management of quality, compliance, supply and safety risks. Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. Identification and implementation of continuous improvement opportunities within our processes and systems. Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Basic Qualifications High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree Top 3 Must Have Skill Sets: Previous work on GMP Facilities PQA or Mfg preferably Drug Substance Experience Previous work with Batch records/Deviations/QA Oversight Nice to have: B.S. degree Day to Day Responsibilities: On the floor guidance/Mfg support Oversee compliance in execution Batch Record Review SOP review/Approvals Deviation Review Help Mfg Problem solve with Quality mindset

Job Title: Quality Assurance Senior Associate Duration: 12 Months Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Summary: Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance Responsibilities: • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. • Oversee and provide guidance during on-the-floor analytical testing. • Ensure that changes that could potentially impact product quality are assessed according to procedures. • Ensure that deviations from established procedures are investigated and documented per procedures. • Alert senior management of quality, compliance, supply and safety risks. • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. • Identification and implementation of continuous improvement opportunities within our processes and systems. • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Requirements: Previous work on GNP Facilities PQA or Mfg preferably Drug Substance Experience Previous work with Batch records/Deviations/Qa Oversight Nice to have: B.S. degree

100% ONSITE 1 year contract This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem and ongoing Automation support to the Manufacturing floor and expansion projects. • Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV). • Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight. • Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution. • Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors. • Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements. • Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation. o May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders. • Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required. • Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. • Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies. • Participate in meetings related to document planning, execution, and issue resolution. • Escalate any compliance concerns or critical gaps to QA management. • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. Basic Qualifications Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

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.

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

Place of Support Womack Army Medical Center (WAMC), Fort Bragg, Fayetteville, NC. The Construction Quality Management (CQM) / Quality Assurance (QA) manager will perform on-site Quality Assurance services for Womack Army Medical Center (WAMC). WAMC has several DHA-approved Sustainment, Restorations and Modernization (SRM) program projects with two projects in development for FY25- FY26 starts. The construction management specialist will attend meetings, review submittals, and perform onsite visits. Individual is responsible for the effective development of construction documents and oversight of the project management of renovation and new construction projects to ensure the “Owners” requirements for quality and timeliness are achieved. This is accomplished through working with other contractors and contacting activities, such as USA Corps of Engineers to accomplish the work. The candidate will advise the COE Program and Project Manager, the Facilities Manager, and DHA- Facilities Operations Branch, or their representative of all issues that require his or her action or the action of senior leaders. Key areas of focus are the review of documentation to ensure that required documentation is complete and usable for the maintenance and operations of the facility once the project is turned over to the Command. The right candidate must have a working knowledge of the medical design criteria, the Uniform Facility Criteria (UFCs) and Federal Building Code requirements. The applicant should possess a strong work ethic and able to show initiative to learn items related to any given task. Compensation will be commensurate with experience. Roles and Responsibilities Serve as onsite CQM/QA manager for DHA-approved activities such as new buildings, renovation, repairs, deficiency-correction, and replacement construction projects. Ensure that the new buildings meet all the requirements of the plans and specifications of the contract documents. Maintain records of all necessary construction documentation such as financial cost accounting, meetings, drawings, submittals, applications for payments, change orders, proposals, purchase orders, communications, transmittals, notes, etc. Attend applicable progress meetings (as specified by COE Program and Project Manager, the Facilities Manager, and DHA - Facilities Operation Branch, or their representative) with project architects, engineers, and prime contractors. Provide report of meeting to Facilities Director with identification of any problems or difficulties and recommendations for resolution. Review and approve submittals, shop drawings, and samples as “Owner”. Perform continual on-site surveillance of construction activities. Inspect the contractor's quality control activities. Monitor and record testing required by contract documents. Maintain progress photos of the project. Review and evaluate HVAC plans, specifications, installation, testing and balance, and field verifications. Review and evaluate all change orders recommended by the architect or his consultants, all change order requests, and cost proposals made by the contractors, and recommend action to be taken to the Facilities Manager. Aid in preparing punch list corrections prior to acceptance of the building or portions of it by the owner. Review final 'as built' drawings as Owners Representative. Receive all warranties and provide all mechanical and electrical systems information, including operation and maintenance manuals, to Keesler Medical Center personnel responsible for ongoing maintenance. Provide recommendations for design modifications. Prepare reports and perform special projects as required by the Facilities Manager. Complete any site-specific training required by the facility manager. Provide effective coordination, support, and promotion of interactions with other staff offices and organizations. Coordinate project related information with other subject matter experts (SMEs) that are contracted with DHA. Qualifications and Education Requirements Bachelor's degree preferred. ASHE Health Care Construction Certificate (HCC) preferred. Minimum of 10 years experience in one or more of the following positions on construction projects: Project Superintendent, Quality Control Representative, Quality Control Manager, Project Manager, or Project Executive. Five (5) years' technical experience with building systems (i.e., mechanical systems, electrical systems, etc.). Five (5) years' experience developing multidisciplinary real property improvement projects or government approved resume. Experience working with DOD Organizational Structure, Processes, and Procedures. Experience creating comprehensive reports with engineering-based recommendations. Experience with USACE Quality Control processes and reporting. Knowledge of construction cost estimating. Working knowledge of the DMLSS - FM Module, working knowledge with current National Fire Protection (NFPA) codes, and standards applicable to Healthcare; knowledge and familiarity with current Occupational Safety and Health Administration (OSHA) requirements for medical facilities; knowledge of Joint Commission Accreditation standards associated with Life Safety and Environment of Care standards; and knowledge of facility condition inspections, real property inventory procedures, corrective action planning, and high level root cause failure analysis. Possess an active favorable NACI. Working knowledge of the medical design criteria, the Uniform Facility Criteria (UFC) and Federal Building Code requirements Strong working knowledge of Microsoft Office, Smartsheet, Microsoft Project, or other project management solution to manage projects. Healthcare Facilities Management experience. Preferred Skills Analytical thinking/critical thinking skills are imperative. Excellent client-facing and internal communication skills. Excellent written and verbal communication skills. Solid organizational skills including attention to detail and multitasking skills. Willingness to adhere to all principles of confidentiality. Must operate in a collaborative and cooperative environment. Ability to show initiative, good judgment, and resourcefulness. Additional Notes This position is on-site at a government installation, the candidate should be comfortable to undergo a background investigation. Work Hours: Monday through Friday, 8 hours per day, excluding Government holidays. Personnel shall not work more than 80 hours in any two-week period. Subject to prior approval by the supported-facility POC or Facilities Manager, variations in work schedules are acceptable when the total hours per week are not exceeded and no obligation is incurred that would require personnel to be paid overtime. Due to the nature of performing services in support of healthcare facilities with an ongoing mission, it is occasionally necessary to work outside of clinic hours to de-conflict spaces. When it is necessary for to work outside of agreed upon daily working hours, the supervising site POC will provide written notice. Place of support: Womack Army Medical Center (WAMC), Fort Liberty, Fayetteville, NC. * The OutFit is a small business that specializes in Project Management and Quality Assurance for DOD Medical Treatment Facilities. We have numerous team contracts to perform services to the US Army Corps of Engineers. We have performed services all over the US at various Medical Treatment Facilities. *All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual preference, gender identity or national origin.

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

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. 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

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_****************).

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.

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.

This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification at with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem at and ongoing Automation support to the Manufacturing floor and expansion projects. **Key Responsibilities:** + Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV). + Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight. + Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution. + Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors. + Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements. + Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation. + May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders. + Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required. + Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. + Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies. + Participate in meetings related to document planning, execution, and issue resolution. + Escalate any compliance concerns or critical gaps to QA management. + In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. **Basic Qualifications:** + Doctorate degree OR + Master degree and 3 years of experience OR + Bachelor degree and 5 years of experience OR + Associate degree and 10 years of experience OR + High school diploma / GED and 12 years of experience **Must Have Skill Sets:** + Previous experience in computer system validation (CSV) or quality oversite of CSV. + Experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired. + Experience with computerized systems including troubleshooting, reliability, and performance improvements. **Day to Day Responsibilities:** + Will work with an established QAV team to support automation and DTI for the site and expansion projects. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

Job Description Job Title Job Reports To (Manager's Title) Quality Control Manager Program Manager Department Job Grade Compensation Operations Status Post date Close date ☐ Exempt ☒ Non-Exempt ☒ Full-Time ☐ Part-Time 10/22/2025 Position Summary: The Quality Control Manager (QCM) will serve as the primary authority for ensuring contract performance objectives, standards, and deliverables are met across all 81st Readiness Division (RD) sites. This position is contingent upon contract award and plays a critical role in maintaining mission readiness, service consistency, and compliance with the contract's Quality Assurance Surveillance Plan (QASP) requirements. The QCM will design, implement, and manage a standardized Quality Control Program that supports all operational areas including Base Operations, Real Property, and Environmental services. Through proactive monitoring, detailed reporting, and root-cause analysis, the QCM will ensure the highest level of quality and customer satisfaction. This position is contingent upon contract award and is for a possible contract. Duties and Responsibilities: Serve as the primary quality authority with full responsibility and accountability for contract compliance, performance standards, and deliverable verification. Direct and maintain a standardized Quality Control (QC) Program across all sites under the 81st RD's area of responsibility. Develop, implement, and continually improve a Quality Control Plan (QCP) consistent with contract requirements and aligned with the government's Quality Assurance Surveillance Plan (QASP) § Employ continuous inspection processes and data-driven trend analysis using mobile Contractor Support System (CSS) checklists and digital dashboards. Conduct quality audits, performance evaluations, and preventive-action reviews to identify systemic issues and implement effective corrective measures. Ensure that inspection findings and trend data are communicated promptly to the Program Manager and government representatives. Facilitate regular QC meetings to evaluate performance results, discuss process improvements, and validate corrective action outcomes. Develop and maintain enterprise-wide quality metrics and performance documentation for reporting to the COR/Stakeholders Collaborate closely with the Program Manager (PM) and Site Safety and Health Officer (SSHO) while maintaining independent oversight per contract requirements. Foster a culture of quality excellence through training, awareness, and accountability across all contract sites. Required Qualifications: The Contractor shall provide a QCM who has full authority and responsibility for assuring performance objectives and standards identified in this contract are met. The QCM must have a minimum of 3 years of satisfactory and relevant experience at a comparable level of responsibility in projects of similar size, scope, and complexity. Must pass a background screen Preferred Qualifications: ISO 9001:2015 Lead Auditor certification (preferred). Bachelor's degree in Quality Assurance, Engineering, Business Administration, or a related technical discipline. Demonstrated experience managing quality programs in DoD, USACE, environments. Strong understanding of FAR 52.246-1 Quality Assurance, inspection protocols, and federal QC documentation standards. Proven ability to employ data-driven methodologies for identifying performance trends and implementing preventive actions. Excellent analytical, communication, and leadership skills, with the ability to drive cross-functional quality initiatives. Proficiency with Contractor Support Systems (CSS), SharePoint, and Microsoft Power BI for QC reporting and analysis. Pay: Negotiable Location: 81st Readiness Division Charlotte, NC Concord, NC Cary, NC Garner, NC McLeansville, NC Winterville, NC High Point, NC Lumberton, NC Morehead City, NC Rocky Mount, NC Salisbury, NC Wilson, NC Winston-Salem, NC Wilmington, NC Knightdale, NC Florence, SC Myrtle Beach, SC Physical and Technical Environment: Prolonged periods of sitting at a desk and working on a computer. · Must be able to lift to 40 pounds at a time. · Must be able to travel to offsite assignments. Benefits: 401(k) Dental insurance Health insurance Life insurance Vision insurance Vacation Time Sick Time (The right is reserved under provisions PL 93-638 Section (b), (f), (g), (i), 20 USD450 Indian Self Determination and Education Assistance Act of 1974 to give PREFERENCE AND OPPORTUNITY for employment, training, and contracts to Indians)

This role is responsible for ensuring the safety, airworthiness, and regulatory compliance of the company's aircraft maintenance program. The position supports the Director of Maintenance and Quality Assurance teams by overseeing maintenance activities, auditing records and vendors, and ensuring all work complies with FAA regulations, approved maintenance manuals, and company policies. Strong attention to detail, regulatory awareness, and a compliance-driven mindset are essential for success in this role. Primary Duties: Ensure that all maintenance performed on company aircraft is done in accordance with approved maintenance manuals and Federal Aviation Regulations. Responsible for auditing the accuracy of all aircraft records and the accompanying maintenance forms. Audit the activities of all contract maintenance agencies for compliance with company manual requirements and FAR's. Responsible for improvements in aircraft records, recording, retention, completeness, and accuracy to maintain the highest standards. Assist in the liaison between the Quality Assurance Department and other departments to ensure accurate communication related to the airworthiness and safety of aircraft. Provide oversight of the CASS program at the direction of the DOM. Ensure company policy and procedures are adhered to. Supply ongoing developmental insights as well as guarantees for regulatory compliance Perform receiving inspections of newly purchased, repaired, overhauled parts or continued service components and hardware to ensure proper documentation from approved vendors, absence of shipping damage, proper packing, protection, and airworthiness certification. Ordering and receiving bulk aviation fuel. Skills & Qualifications: Must hold a valid FAA Mechanics Certificate with both airframe and powerplant ratings. Trained in Audit, Risk Assessment, Root Cause and Human Factors. Must have strong knowledge of Microsoft Windows Office Suite/Outlook Word, Excel and be able to utilize the Internet. This position will entail extensive computer work. Must be able to read, interpret, and follow technical instructions, drawings, schematics, and diagrams. Must be able to climb a ladder and lift up to 25 lbs. We offer competitive salary and benefit package which includes health, dental and vision insurance plus PTO and 401k. Jet Excellence, LLC is an equal opportunity employer that provides equal employment opportunities (EEO).

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.

Career CategoryQualityJob Description 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. 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. What we expect of you 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. 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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 154,692.00 USD - 188,725.00 USD

Pay $31-$33 per hr. Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Responsibilities: • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. • Oversee and provide guidance during on-the-floor analytical testing. • Ensure that changes that could potentially impact product quality are assessed according to procedures. • Ensure that deviations from established procedures are investigated and documented per procedures. • Alert senior management of quality, compliance, supply and safety risks. • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. • Identification and implementation of continuous improvement opportunities within our processes and systems. • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

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