Quality assurance manager jobs in Chapel Hill, NC

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, and facilities. Provide quality oversight of facility upgrades and expansions. This individual is responsible for managing the change control system. Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members. Align QA organization to meet companies' strategic goals. Responsibilities: Provide quality oversight into the Engineering and Validation programs supporting both clinical and commercial operations in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, facilities, cleaning and process validation. Review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program. Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities. Manages the change control system. Works directly with functional areas to review and approve change controls. Works to continuously improve and streamline the change control system. Providing guidance to QA staff on cGMP requirements for validation, facility, utility, production, equipment and computer systems. Subject matter expert accountable for site level compliance of engineering and validation of cGMP systems to the requirements of US and International regulatory agencies. Assess on an on-going basis the changing regulatory environment to establish policy, procedures and processes that drive continued cGMP compliance and business success. Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in formulating inspection responses. In conjunction with the Engineering, Validation and IT teams, develop and manage all qualification and validation policies, procedures, and protocols. Requirements: BS and 12+ year experience or MS and 10+ years' experience in a QA or GMP environment or equivalent. Experience in a QA role supporting validation, engineering, IT and change control required. Experience managing a QA organization for both clinical and commercial operations is beneficial. Previous experience in validation or engineering is required. Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Basic math skills are required. Ability to apply concepts of basic algebra and statistics Physical Demands Sitting for long periods of time at a computer. Push and pull up to 30 lbs. Computer Skills Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, quality management electronic systems Salary Range: $173,000 - $238,700/yr. Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

CS Medical Job Title : Quality Assurance Manager Department or Division : Quality Reports To : Director of QA and RA JOB TASKS, DUTIES, AND RESPONSIBILITIES The Quality Assurance Manager is responsible for helping to execute and improve the Quality Management System to the requirements of the FDA's QMSR and ISO 13485. The Quality Assurance Manager participates in the company's complaint program including analysis of complaint trends and determination of corrective actions (CAPA). The Quality Assurance Manager also helps define metrics; their purpose, source data, and leading the analysis to determine if metrics are being achieved. The Quality Assurance Manager collaborates with the different departments to ensure the company maintains quality compliance with the QMSR and ISO standards. The Quality Assurance Manager maintains and improves reports of quality data to aid in CS Medical interactions with regulators and customers to represent the company's products and processes. The Quality Assurance Manager also manages a team of QC and QA technicians to ensure quality of in-process testing and final acceptance testing along with analysis of complaint and other quality data. JOB DUTIES: Helps execute and improve the Quality Management System. Helps define metrics, purpose, source, analysis methods, sets alert / action limits with clearly documented rationales. Is assigned special projects for Quality Assurance to execute in supporting Research and Development of new products. Supports interactions with regulators, auditors, and customers to represent the company products and processes. Keeps the Risk Management Files up to date and accurate per ISO 14971. Improving, implementing, and validating electronic record systems. Ensures that personnel, who perform tests and inspections, are trained to the documented procedures. Reviews non-conforming reports created by the company and ensures timely closures. Analyzing complaints that need investigation. Creates CAPAs and brings them through the entire CAPA process. Quality Objective data is collected, analyzed and reviewed by the QA Manager. Ensures that only repaired units passing final acceptance testing leave the company for clinical use. Performs other quality duties as required. Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements. Maintain the department as to follow CS Medical's QMS and adheres to FDA QMSR and ISO 13485. Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. Ensures compliance with design controls and design documentation to ensure regulatory requirements are met. MINIMUM QUALIFICATIONS Excellent written and oral communication skills. Strong Documentation skills. Must have experience writing procedures and work instructions. Ability to be both hands on and to lead. Strong analytical and problem-solving skills, including solid understanding of internal and applicable external policies, procedures and standards. A four-year degree or equivalent Strong skills being able to work with, and performing validation of, electronic records 5+ years of broad quality system/regulated environment experience. Working knowledge of applicable standards and regulations including FDA CFR and ISO 13485 Experience in leading a small team of people. PREFERRED QUALIFICATIONS A four-year degree or equivalent with a BS in science or engineering ASQ Certification or other quality certifications are desirable ComplianceQuest electronic quality system management experience Accountabilities Special Projects assigned for Quality Assurance to support Research and Development is completed. Communication and relationship with other departments is one of mutual respect and cooperation. Timely execution of CAPAs. Quality Objectives recorded quarterly. The Quality Management System is improved over time. Helps in 510(k) premarket notifications, EU Technical Files, Health Canada Submissions, and other international submissions. LOCATION This position will be based at our Creedmoor, NC office. Terms of employment This is a full-time, salaried, exempt position. HOURS The general hours shall be Monday - Friday, 8:00am to 5:00pm with an hour break for lunch. Work Environment Work is regularly performed in office and warehouse environments. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is frequently required to sit. The employee is occasionally required to stand and/or walk. The employee must occasionally lift, carry, push or pull up to 20 pounds. Travell Minimal travel may be required. BENEFITS Compensation package includes health insurance, dental insurance, vision insurance, short term disability, life insurance and Teladoc following an introductory period. The Company offers a 401K plan with employer contribution. The Company also offers paid time off and paid holidays. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Working at Freudenberg: We will wow your world! Responsibilities: Maintain and improve the QMS: Manage and continuously improve the QMS to ensure compliance with ISO 9001 standards and other relevant industry certifications. Conduct internal audits: Plan and execute internal quality audits to verify adherence to QMS procedures. Facilitate third-party and customer audits, and manage corrective actions. Support top management: Report on the performance of the QMS and any opportunities for improvement to senior leadership. Ensure customer focus: Promote awareness of customer requirements throughout the organization. Provide training: Develop and deliver training to site personnel on quality procedures, standards, and awareness. Promote quality culture: Advocate for a culture of quality, safety, and continuous improvement throughout the organization. Interface with customers: Act as the primary point of contact for customer quality inquiries and concerns. Qualifications: Education: Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience. Minimum of 5-7 years in a quality leadership or management role. Proven experience implementing and maintaining an ISO 9001 compliant QMS. Experience managing a quality team within an ISO 9001 organization. Thorough knowledge of ISO 9001:2015 standards. Strong leadership, communication, and interpersonal skills. Experience with statistical analysis and data-driven problem-solving. Proficiency with quality management software and data analysis tools. Internal or Lead Auditor certification for ISO 9001 is highly preferred The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Performance Materials LP (USA)

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. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. 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). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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. 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 $133,500 - $246,400 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

This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, and facilities. Provide quality oversight of facility upgrades and expansions. This individual is responsible for managing the change control system. Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members. Align QA organization to meet companies' strategic goals. Responsibilities: Provide quality oversight into the Engineering and Validation programs supporting both clinical and commercial operations in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, facilities, cleaning and process validation. Review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program. Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities. Manages the change control system. Works directly with functional areas to review and approve change controls. Works to continuously improve and streamline the change control system. Providing guidance to QA staff on cGMP requirements for validation, facility, utility, production, equipment and computer systems. Subject matter expert accountable for site level compliance of engineering and validation of cGMP systems to the requirements of US and International regulatory agencies. Assess on an on-going basis the changing regulatory environment to establish policy, procedures and processes that drive continued cGMP compliance and business success. Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in formulating inspection responses. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements -Bachelor's Degree with 12+ years of experience OR -Master's Degree with 10+ years of experience in a QA or GMP environment -Experience in a QA role supporting validation, engineering, IT and change control -Experience managing a QA organization in for both clinical and commercial operations -Previous experience in validation or engineering -Proven ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public -Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

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

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

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing. Job Description ESSENTIAL FUNCTIONS: Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines. Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications. Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements. Maintain accurate records of all QC activities, including test results, deviations, and corrective actions. Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality. Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Prepare for and participate in internal and external audits, including regulatory inspections. Oversee calibration, validation, and maintenance of laboratory instruments. Provides subject matter assistance for LIMS, methods, testing, and validation. Manages QC testing group to achieve compliant testing in a timely manner. Manages Lab investigations and OOSs including remediation of potential compliance concerns. Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement. Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation. Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions. Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations. Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades. Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory. Ensures key turnaround timelines for customer service and compliance requirements are achieved. Performs as a subject matter expert during customer and regulatory audits. Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Develops and coaches to build talent. Participate in a 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: B.S. /B.A. in Physical Science required. Master's Degree preferred. Experience: 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements Preferred Skills/Qualifications: Other Skills/Competencies: Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories Experience with testing API or Pharma products Experience leading a group of up to 20 people with 24/7 shift operations Excellent written and verbal communication and leadership skills Ability to work in and promote a team environment Working knowledge of Six Sigma and/or Lean manufacturing tools Sense of urgency. Action oriented/drives for results Excellent communication and interpersonal skills Team orientation/strong team player Ability to coach, mentor and teach Excellent decision making, problem solving and analytical skills Strong managerial courage Ability to influence change at all levels of the organization Detail-oriented with the ability to work under tight deadlines Excellent conflict management skills Builds positive relationships with others Excellent time management and prioritization skills Excellent technical writing skills LIMS experience preferred Knows the difference between managing and leading and when to apply each Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication, RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Site Quality Director Work is performed without appreciable direction Develops strategic objectives for group managed Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S. This position has several direct reports WORKING CONDITIONS: 60% normal office and meeting room conditions. 40% Laboratory and Plant environment including exposure to raw materials and finished products. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. Some off shift and weekend work can be expected; travel requirements are minimal DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed. Additional Responsibilities * Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients. * Trains the project team on their criteria and implementation. * Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans. * Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication. * Ensures Corporate Quality initiatives and goals are achieved. * Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews. * Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. * Reviews utility matrices developed to start up and commission systems and skids. * Directs the tracking of deficiencies, test results, or other regularly reported quality control data. * Manages non-conformance reporting activities and tracks efficiencies from identification through resolution. * Monitors performance of quality control systems to ensure effectiveness and efficiency. * Verifies that the construction of systems and equipment are installed in accordance with approved construction documents. * Reviews plans and specifications to ensure requirements are met for each construction process. * Understand and apply federal, state, and local codes, policies, laws, and regulations. * Identifies quality problems or areas for improvement and recommends solutions. * Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected. * Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation. * Implements the corporate safety culture and principles into the QA/QC programs. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! Qualifications & Requirements * B.S. in a Science, Engineering, Construction management, or related field. * Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering. * Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action. * Proficient skill level in Microsoft Office Suite. Preferred Qualifications * First Aid/CPR training. * Primavera P6 and MS Project knowledge. * Commissioning and System startup experience. Safety * You will travel 50% of the time, or as necessary to complete duties. * You may be assigned to a client for an extended period of time (1-2 years). * OSHA 10 certification (IPS will provide tools) must be maintained during employment. * Overnight travel is possible. * You will focus on construction field activity and office time will be limited. * You will visit Client sites and will be required to adhere to stated safety rules. * This position is a safety-sensitive position. * The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here! * B.S. in a Science, Engineering, Construction management, or related field. * Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering. * Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action. * Proficient skill level in Microsoft Office Suite. Preferred Qualifications * First Aid/CPR training. * Primavera P6 and MS Project knowledge. * Commissioning and System startup experience. Safety * You will travel 50% of the time, or as necessary to complete duties. * You may be assigned to a client for an extended period of time (1-2 years). * OSHA 10 certification (IPS will provide tools) must be maintained during employment. * Overnight travel is possible. * You will focus on construction field activity and office time will be limited. * You will visit Client sites and will be required to adhere to stated safety rules. * This position is a safety-sensitive position. * The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas All interviews are conducted either in person or virtually, with video required. At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed. Additional Responsibilities * Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients. * Trains the project team on their criteria and implementation. * Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans. * Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication. * Ensures Corporate Quality initiatives and goals are achieved. * Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews. * Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. * Reviews utility matrices developed to start up and commission systems and skids. * Directs the tracking of deficiencies, test results, or other regularly reported quality control data. * Manages non-conformance reporting activities and tracks efficiencies from identification through resolution. * Monitors performance of quality control systems to ensure effectiveness and efficiency. * Verifies that the construction of systems and equipment are installed in accordance with approved construction documents. * Reviews plans and specifications to ensure requirements are met for each construction process. * Understand and apply federal, state, and local codes, policies, laws, and regulations. * Identifies quality problems or areas for improvement and recommends solutions. * Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected. * Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation. * Implements the corporate safety culture and principles into the QA/QC programs. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights!

Environmental Holdings Group, LLC dba Alloy is seeking an experienced Quality Control Manager (QCM) to oversee abatement and demolition projects across multiple locations. The successful candidate will be responsible for ensuring that all aspects of the project are executed to meet quality standards and contract requirements, including oversight of subcontractor activities, three-phase quality control inspections, and regular reporting. Travel to the following locations will be required: Columbus, GA; Savannah, GA; White Sands, NM; El Paso, TX; Albuquerque, NM; Wichita Falls, TX; Petersburg, VA. Key Responsibilities: Manage daily quality control operations in compliance with the approved Quality Control Plan (QCP). Implement the three-phase quality control system (preparatory, initial, and follow-up inspections) for all definable features of work (DFOW). Oversee and ensure that all work meets or exceeds project specifications and regulatory standards. Prepare and maintain detailed documentation, including Daily Quality Control Reports and project submittals. Supervise and work closely with the Site Superintendent, Site Safety Health Officer (SSHO), and subcontractors to ensure compliance with safety and quality protocols. Conduct and document inspections, tests, and surveillance of project activities. Act as the primary point of contact for quality-related issues and liaise with the U.S. Army Corps of Engineers (USACE). Stop any work that does not comply with contract requirements and direct corrective actions. Perform punch-out inspections, final inspections, and manage project closeout documentation. Qualifications: Minimum of 5 years of experience in quality management for abatement and demolition projects or similar construction environments. USACE Construction Quality Management (CQM) certification required. OSHA 30-hour Construction Safety and Health training. Experience with asbestos and hazardous materials abatement is highly preferred. Proficient in managing quality control procedures in accordance with USACE standards, including RMS 3.0/CM software. Strong communication and organizational skills, with experience in preparing detailed quality documentation and reports. Preferred Certifications: USACE Construction Quality Management (CQM) certification OSHA 30-hour certification First Aid and CPR certification EM385-1-1 Fall Protection training Why Join Us? Environmental Holdings Group, LLC dba Alloy offers the opportunity to work on significant federal demolition and abatement projects across the U.S. We prioritize safety, quality, and teamwork, and provide our employees with a dynamic and supportive work environment.

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)

Legal Entity: American Honda Motor Co., Inc. Business Unit: Power Equipment Division: Manufacturing Career Level: 3 Salary Range: $54,900.00 - $82,400.00 Job Purpose: Minimizing supplier quality issues using root cause analysis, implementing temporary solutions and permanent countermeasures to ensure minimal line impact and optimal product quality. Key Accountabilities: Create all reporting documentation to communicate to supplier base (HTR's, Inspection Data Sheets, Supplier Visits Reports, Etc.) that are created through utilization of lab equipment and parts measurement to drawing. Approve/confirm supplier countermeasures and approve a part change prior to production utilizing Honda Trouble Report System and IPPAAR procedures as compared to official part drawing dimensional data. Perform in-depth analysis and implement/develop proposals for countermeasure related to the production process to minimize downstream customers concerns. (Manufacturing Departments) Oversee and manage complex problem-solving analysis and investigations. Negotiating and communicating quality activity with suppliers, internal and external (Quality Assurance Visits) Perform judgement, disposition, and handling functions for non-conforming part problems. Qualifications, Experience, and Skills: BS ENG degree + 0 years AS ENG degree + 4 years HS degree + 6 years 0-6 years Engineering Experience (see above) Knowledge of Microsoft Office (Excel, Word & PowerPoint) Able to work in Team environment Able to work a flexible schedule Ability to adapt to changing priorities Analytical problem-solving skills Excellent communication skills (by phone, in person and e-mail) Ability to manage multiple tasks by prioritizing and balancing workload Able to work independently with minimal supervision, show initiative and act independently to resolve problems Working Conditions: Must be able to work a flexible schedule including shifts and weekends as necessary Must be able to work overtime as necessary to support department needs (short term and/or scheduled) Proof of a valid driver's license Able to travel domestic or foreign Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.

Job Description The Quality Control Manager is responsible for planning, coordinating and developing the project specific Quality Assurance/Quality Control plan that incorporates policies and procedures necessary to deliver the project fully compliant with the contract terms of the project. Responsibilities Partner with the project team to understand, plan, and implement the contract drawings and specifications Collaborate with the owner, design team, and contractors to ensure quality and timeliness of project construction and completion Implement and manage the "Three Phases of Control" Quality Control Plan Schedule and conduct quality control meetings - Preparatory, Initial Phase, Follow-up Control documents related to quality control functions Establish testing procedures in accordance with contract specifications Manage inspections process Coordinate third party testing agents and interface with the Owner's representatives as required Closely track and maintain a project deficiency log Manage the punch list process Oversee project closeout deliverable process-training, O&Ms Confer directly with the executive management team Encourage, lead, and/or participate in staff training and development Basic Qualifications Undergraduate degree in a construction or related discipline or relevant experience Minimum 5-8+ years verifiable construction quality control and/or inspection experience Takes initiative and personal responsibility to always deliver value and excellence Uses expertise to create a vision and aligns the team to deliver/achieve desired outcomes A track record of establishing/contributing to creative strategic solutions Ability to communicate effectively with, persuade, and gain "buy-in" from, a broad range of stakeholders (leadership team, Business Unit Leader, direct reports, clients, trade partners, and third party providers) Alignment to BE&K standards, self-motivated, results oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction and executes Preferred Qualifications Experience in large scale Bio-Pharma construction projects Prior experience developing and managing Quality Control Plans Physical Requirements: Ability to perform physical activities such as climbing, lifting, balancing, walking, and handling materials. Must be able to work in various weather conditions, including extreme heat and cold. Capable of standing and walking for extended periods. Ability to lift and carry up to 50 pounds. Equal Employment Opportunity Statement: BE&K Building Group is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Job Posted by ApplicantPro

Job Description Quality Assurance and Control: Establish systems and processes to verify that products and services are designed, developed, and manufactured in accordance with Lenovo's global quality standards and regulatory requirements. Product & Process Monitoring: Oversee manufacturing and software development processes to ensure operational excellence and consistent high-quality output. Testing & Analysis: Perform inspections, testing, and detailed analysis of products or systems to identify defects and verify conformance to performance and technical specifications. Problem Solving: Utilize root cause analysis and corrective action methodologies to resolve quality issues and prevent recurrence. Data-Driven Improvements: Collect and analyze quality and production data to drive process improvements, reduce variability, and enhance product performance. Collaboration: Partner cross-functionally with design, engineering, manufacturing, and management teams to embed quality throughout the product lifecycle. Continuous Improvement: Champion a culture of continuous improvement to optimize processes, enhance product reliability, and exceed customer expectations. Skills Quality engineering, Program management Top Skills Details Quality engineering Additional Skills & Qualifications Master's degree in Engineering, Operations, or related discipline. 5+ years of quality experience within a global manufacturing or technology organization. Lean Six Sigma Green Belt or higher certification. Proficiency with Minitab, Power BI, or SAP quality modules for reporting and data visualization. Experience with statistical process control (SPC), FMEA, and corrective/preventive action (CAPA) methodologies. Proven record of leading cross-functional quality improvement projects. Experience Level Expert Level Job Type & Location This is a Contract position based out of Whitsett, NC. Pay and Benefits The pay range for this position is $45.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Whitsett,NC. Application Deadline This position is anticipated to close on Dec 11, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Labcorp is seeking a Laboratory Quality Coordinator to join our Core Chemistry team located in Burlington, NC! The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other Labcorp sites. This position is a great opportunity for laboratory professionals that have an eye for detail and a passion for quality assurance. Work Schedule: Monday-Friday, 8:00am-5:00pm Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Job Responsibilities * Support projects and activities related to quality assurance, control, improvement and training * Prepare and support the laboratory for regulatory inspections * Maintain all necessary documents and materials required for inspections * Provide backup inspection support to laboratory during inspections * Keep up with all required proficiency testing and examinations * Coordinate and track external and internal proficiency testing * Perform internal audits and prepare audit reports * Prepare reoccurring quality reports for laboratory operations * Stay current with all regulatory agency and proficiency test requirements * Provide proper initiation and use of Master Control forms for audit purposes * Participate in monthly Quality Meeting and compose minutes * Perform administrative and clerical duties as needed Requirements: * Associate's degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or non-traditional Associate's degree to meet local regulatory (CLIA & State) requirements - Bachelor's degree is a plus * 3 years of relevant experience, preferably in a clinical diagnostic setting or in a quality related position * Previous experience as a Medical Technologist/Technician preferred * General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements preferred * Basic understanding of audit related requirements and procedures * Working knowledge of quality assurance best practices and procedures * Excellent analytical, critical thinking and problem-solving skills * Strong communication skills; both written and verbal * High level of attention to detail with strong organizational skills * Ability to work independently and within a team environment * Strong computer skills with proficiency with MS Office programs If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, apply today! Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

Job Description Responsible for supervision of the day-to-day operations of the performance improvement and risk management functions of the organization. He/she will assure that accurate and complete data is used to assess quality of services delivered, collaborate with leadership and clinicians to strategize, and monitor quality improvement modalities, and identify opportunities for minimizing risk in the delivery of services. Assist the organization in fulfilling its mission of providing high quality compassionate health care and implementing a culture of quality at all levels of the organization. RESPONSIBILITIES AND DUTIES To provide leadership and advice in the implementation of the organizational Quality Improvement/Quality Assurance Plan; To work with medical staff as well as accounting and medical coders to achieve maximum accuracy and completeness of coding for medical services provided; To assist the Chief Medical Officer in direction and implementation of the activities of the Quality and Safety Committee; To compile assessment of areas of maximum risk within the organization at least quarterly and recommend strategies for minimizing risk of adverse events; To communicate effectively with staff at all levels in initiatives involving quality improvement or minimization of risk; Serve as a local subject matter expert on electronic health record (EHR) and ancillary data infrastructure. Monitor clinical workflows and recommend process improvements to optimize clinical service delivery and related data capture; Provide timely consultation and training to both providers and staff that enhance the quality of care being provided and the accuracy of data being captured in the clinical documentation, coding and billing processes; Provides orientation to new staff members in the areas of Performance Improvement, OSHA, and Clinical Policies and Procedures; Accreditation: Recommend improvements to programs, policies and/or workflows to ensure PCMH status is maintained and advanced into the future; Quality: Partner with the Chief Medical Officer to regularly monitor all facets of FCCHC's board-approved Quality Improvement / Quality Assurance Plan, including those specific clinical initiatives mandated by the Health Resources and Services Administration (HRSA), Center for Medicare and Medicaid Services (CMS) and contracted managed care organizations (MCO's). Ensure that FCCHC providers are well informed of quality measures and well equipped to succeed in future value-based payment initiatives; Participates in other related activities affecting the clinic programs (e.g., grant application requirements, patient data analysis, committees, recruitment and orientation); Complete the Uniform Data System and Federal Tort Claims Act on an annual basis based upon required due dates; Produce regular reports regarding quality indicators and other chart audit data. Preparations for Quality Assurance staff meetings by developing agendas, taking minutes and compiling and distributing packets to include preparation of the CMO's Report to the Board of Directors; Audit charts on the use of various screening tools and as requested by the Chief Medical Officer; Risk: Oversee a portfolio of initiatives that collectively minimize FCCHC's liability and malpractice risk exposure. Coordinate, schedule and/or deliver timely trainings on identified risk topics. Consult with Chief Financial Officer and insurance broker to leverage external training and resources that minimize risk. Serve as key member of FCCHC's Quality and Safety Committee. Chairs committee in the absence of the Chief Medical Officer; and Performs other necessary duties as required by the CMO to meet the goals of providing primary health care services. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: Bachelor's degree in a clinical specialty as a minimum, advance degree preferred. Minimum 3-5 years of experience in clinical quality and risk management activities. LANGUAGE SKILLS: Ability to read and comprehend written materials. Ability to write clearly and concisely. Ability to communicate effectively one-on-one or for small groups. Ability to make formal presentations to groups. Ability to communicate with patients and family members of various educational, socio-economic, and cultural backgrounds. MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rates, ratios and percents. REASONING ABILITY: Ability to solve practical problems and utilize appropriate steps for problem resolution. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to exercise sound judgment. COMPETENCY/SKILLS REQUIREMENTS: Competency required in the areas of interpersonal communications, excellent verbal and written skills, and knowledgeable of Medicare and regulatory and credentialing criteria and standards. Knowledge of safety standards, spread of organisms, and the adult learning process. CPR certified. OTHER SKILLS AND ABILITIES: Ability to operate all basic office machines and equipment. Ability to assess and visually present data using run charts, flow charts, scatter diagrams, control charts, histograms, decision matrices, etc. Ability to deal effectively with stress and to work under pressure. Ability to exercise flexibility in work schedule. Basic word processing and general computer skills. Computer skills to include proficiency with the use of Microsoft word, excel, publisher, PrintShop. PHYSICAL/MENTAL DEMANDS: The physical/mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disability to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear, sit, and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, climb, balance on two feet, stoop, kneel, crouch, or reach with hands and arms. The employee must occasionally lift and/or move patients of varying weight. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Mental demands include the ability to learn and adapt to changes, exercise discretion and good judgment, develop options and solutions to crisis and problems, gather and analyze facts, pay close attention to detail, courteous and professional, deal with stressful situations such as emergencies and/or staff shortages, and to adhere to company policies and procedures. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Powered by JazzHR HpJvIMU3Kh

Job Description Quality Assurance and Control: Establish systems and processes to verify that products and services are designed, developed, and manufactured in accordance with Lenovo's global quality standards and regulatory requirements. Product & Process Monitoring: Oversee manufacturing and software development processes to ensure operational excellence and consistent high-quality output. Testing & Analysis: Perform inspections, testing, and detailed analysis of products or systems to identify defects and verify conformance to performance and technical specifications. Problem Solving: Utilize root cause analysis and corrective action methodologies to resolve quality issues and prevent recurrence. Data-Driven Improvements: Collect and analyze quality and production data to drive process improvements, reduce variability, and enhance product performance. Collaboration: Partner cross-functionally with design, engineering, manufacturing, and management teams to embed quality throughout the product lifecycle. Continuous Improvement: Champion a culture of continuous improvement to optimize processes, enhance product reliability, and exceed customer expectations. Skills Quality engineering, Program management Top Skills Details Quality engineering Additional Skills & Qualifications Master's degree in Engineering, Operations, or related discipline. 5+ years of quality experience within a global manufacturing or technology organization. Lean Six Sigma Green Belt or higher certification. Proficiency with Minitab, Power BI, or SAP quality modules for reporting and data visualization. Experience with statistical process control (SPC), FMEA, and corrective/preventive action (CAPA) methodologies. Proven record of leading cross-functional quality improvement projects. Experience Level Expert Level Job Type & Location This is a Contract position based out of Whitsett, NC. Pay and Benefits The pay range for this position is $45.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Whitsett,NC. Application Deadline This position is anticipated to close on Dec 11, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Labcorp is seeking a Laboratory Quality Coordinator to join our Core Chemistry team located in Burlington, NC! The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other Labcorp sites. This position is a great opportunity for laboratory professionals that have an eye for detail and a passion for quality assurance. Work Schedule: Monday-Friday, 8:00am-5:00pm Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Job Responsibilities Support projects and activities related to quality assurance, control, improvement and training Prepare and support the laboratory for regulatory inspections Maintain all necessary documents and materials required for inspections Provide backup inspection support to laboratory during inspections Keep up with all required proficiency testing and examinations Coordinate and track external and internal proficiency testing Perform internal audits and prepare audit reports Prepare reoccurring quality reports for laboratory operations Stay current with all regulatory agency and proficiency test requirements Provide proper initiation and use of Master Control forms for audit purposes Participate in monthly Quality Meeting and compose minutes Perform administrative and clerical duties as needed Requirements: Associate's degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or non-traditional Associate's degree to meet local regulatory (CLIA & State) requirements - Bachelor's degree is a plus 3 years of relevant experience, preferably in a clinical diagnostic setting or in a quality related position Previous experience as a Medical Technologist/Technician preferred General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements preferred Basic understanding of audit related requirements and procedures Working knowledge of quality assurance best practices and procedures Excellent analytical, critical thinking and problem-solving skills Strong communication skills; both written and verbal High level of attention to detail with strong organizational skills Ability to work independently and within a team environment Strong computer skills with proficiency with MS Office programs If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, apply today! Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.