Quality assurance manager jobs in Jacksonville, NC

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!

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

Source One is a consulting services company and we're currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing client in Wilson, NC This role will be onsite and available to candidates local to the Fort Worth, TX area. No Third-Party, No Corp to Corp, No Sponsorship Title: Project Manager II - Quality Management Systems Location: Wilson, NC Onsite (Mon-Fri, 40 hours) Contract Duration: 12 months, with likely extension Pay Rate: $53.85 per hour (w2) MUST HAVE KNEAT EXPERIENCE! Description: Quality Management Platform Analyst, located in Wilson, NC. We need a forward-thinking, data analyst, to evaluate, road map and construct an area within our workspace in Kneat to house our method verification and transfer execution worksheets protocols and reports Key Responsibilities: • Train on and establish an account in Kneat, • Evaluate how to optimally apply the system, • Construct the needed infrastructure in our workspace and roadmap the execution Qualifications Education: BS Experience and Skills: Required: • Incumbent must be proficient with Word, Excel, Power Point, have the soft skills needed to nurture change, as well as, the acuity to use software nuanced to operate in a regulated environment. - Generally Requires 8-10 Years Work Experience - Kneat experience required Preferred: • A Major in Bio-Medical Engineering, Chemistry or Biology Other: Available to work full-time (40 hrs./week) with reliable transportation to and from work Must be available to work Monday through Friday 8AM to 5PM Must be able to work in the US and must not require sponsorship for employment visa status now or in the future (e.g., FI, H1-B status) Top Three Skills: Experience using Kneat, MS word and in writing method validation or transfer protocols

We are At Synechron, we believe in the power of digital to transform businesses for the better. Our global consulting firm combines creativity and innovative technology to deliver industry-leading digital solutions. Synechron's progressive technologies and optimization strategies span end-to-end Artificial Intelligence, Consulting, Digital, Cloud & DevOps, Data, and Software Engineering, servicing an array of noteworthy financial services and technology firms. Through research and development initiatives in our FinLabs we develop solutions for modernization, from Artificial Intelligence and Blockchain to Data Science models, Digital Underwriting, mobile-first applications and more. Over the last 20+ years, our company has been honored with multiple employer awards, recognizing our commitment to our talented teams. With top clients to boast about, Synechron has a global workforce of 14,500+, and has 58 offices in 21 countries within key global markets. Our challenge We are seeking a detail-oriented and test-focused QA Automation Engineer with hands-on experience in Loan IQ to join our team. The ideal candidate will be responsible for designing, developing, and executing automated test scripts to ensure the quality and functionality of Loan IQ applications, helping us deliver robust and reliable lending software solutions. Additional Information* The base salary for this position will vary based on geography and other factors. In accordance with law, the base salary for this role if filled within Charlotte, NC is $105k - $110k/year & benefits (see below). The Role Responsibilities: Develop and maintain automated test scripts for Loan IQ module testing using tools like Selenium, UFT, or other automation frameworks. Collaborate with business analysts, developers, and QA teams to understand functional requirements and convert them into comprehensive test cases. Execute automated and manual tests to identify bugs, issues, and potential improvements. Perform regression testing to verify bug fixes and updates. Work closely with the development team to troubleshoot and resolve defect issues. Develop and document testing strategies, plans, and reports. Participate in Agile/Scrum ceremonies, including sprint planning and retrospectives. Continuously improve automation frameworks, testing processes, and methodologies. Maintain test data and environment configurations. Requirements: Write and execute SQL queries to validate data integrity, consistency, and accuracy across multiple database tables. Perform backend data validation for CRUD operations. Compare data between source and target systems during ETL or migration testing. Create and maintain SQL test cases and test data for functional and regression testing. Identify data-related issues and report them with clear defect documentation. Automation Testing (Selenium) Design, develop, and maintain Selenium WebDriver scripts using Java (or Python, as applicable). Implement test automation frameworks (Hybrid, POM, Data-Driven, TestNG). Integrate automation scripts with CI/CD pipelines (e.g., Jenkins, GitHub Actions). Automate UI and functional test cases, and generate detailed execution reports. Perform cross-browser testing and ensure test reliability across environments. Reporting & Documentation Prepare and maintain test plans, test cases, and test scripts. Track and report test execution results using tools like QMetry, JIRA, or TestRail. Collaborate with development and business teams to resolve defects. Participate in requirement reviews, sprint planning, and retrospectives. We offer: A highly competitive compensation and benefits package. A multinational organization with 58 offices in 21 countries and the possibility to work abroad. 10 days of paid annual leave (plus sick leave and national holidays). Maternity & paternity leave plans. A comprehensive insurance plan including medical, dental, vision, life insurance, and long-/short-term disability (plans vary by region). Retirement savings plans. A higher education certification policy. Commuter benefits (varies by region). Extensive training opportunities, focused on skills, substantive knowledge, and personal development. On-demand Udemy for Business for all Synechron employees with free access to more than 5000 curated courses. Coaching opportunities with experienced colleagues from our Financial Innovation Labs (FinLabs) and Center of Excellences (CoE) groups. Cutting edge projects at the world's leading tier-one banks, financial institutions and insurance firms. A flat and approachable organization. A truly diverse, fun-loving, and global work culture. S YNECHRON'S DIVERSITY & INCLUSION STATEMENT Diversity & Inclusion are fundamental to our culture, and Synechron is proud to be an equal opportunity workplace and is an affirmative action employer. Our Diversity, Equity, and Inclusion (DEI) initiative ‘Same Difference' is committed to fostering an inclusive culture - promoting equality, diversity and an environment that is respectful to all. We strongly believe that a diverse workforce helps build stronger, successful businesses as a global company. We encourage applicants from across diverse backgrounds, race, ethnicities, religion, age, marital status, gender, sexual orientations, or disabilities to apply. We empower our global workforce by offering flexible workplace arrangements, mentoring, internal mobility, learning and development programs, and more. All employment decisions at Synechron are based on business needs, job requirements and individual qualifications, without regard to the applicant's gender, gender identity, sexual orientation, race, ethnicity, disabled or veteran status, or any other characteristic protected by law.

Duration: 12 months Skills Required Role will be 100% onsite in Wilson, NC There will be 2 interviews; 1 video conference, and 1 will be onsite Bachelors degree is required This role is considered a Quality Management Platform Analyst Will assist with a plan, a template with utilizing software platform for method transfers and qualifications Must have Method Transfer knowledge/experience Must have Programming exp Required to have Kneat experience Work within the team to help develop the system Knowledge of method verification or method transfers Basic SQL exp, NOT coding Must have communication skills Must be self-driven CGMP exp Should have 8-10 years of exp MUST be able to show the candidate has used Kneat to generate protocols! Description: Quality Management Platform Analyst, located in Wilson, NC. We need a forward-thinking, data analyst, to evaluate, road map and construct an area within our workspace in Kneat to house our method verification and transfer execution worksheets protocols and reports Key Responsibilities: • Train on and establish an account in Kneat, • Evaluate how to optimally apply the system, • Construct the needed infrastructure in our workspace and roadmap the execution Qualifications Education: BS Experience • Incumbent must be proficient with Word, Excel, Power Point, have the soft skills needed to nurture change, as well as, the acuity to use software nuanced to operate in a regulated environment. - Generally Requires 8-10 Years Work Experience - Kneat experience required Preferred: A Major in Bio-Medical Engineering, Chemistry or Biology Other: Available to work full-time (40 hrs./week) with reliable transportation to and from work Must be available to work Monday through Friday 8AM to 5PM Must be able to work in the US and must not require sponsorship for employment visa status now or in the future (e.g., FI, H1-B status) Top Three Skills: Experience using Kneat, MS word and in writing method validation or transfer protocols About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: I.Prudvi kumar Email: ******************************* Internal Id: 25- 54461

Immediate need for a talented Project Manager 2 - Quality Engineering/Quality Management Platform Analyst. This is a 12 Months Contract opportunity with long-term potential and is located in Wilson, NC(Onsite). Please review the job description below and contact me ASAP if you are interested. Job Diva ID: 25-94614 Pay Range: $51 - $53/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Train on and establish an account in Kneat, Evaluate how to optimally apply the system, Construct the needed infrastructure in our workspace and roadmap the execution Available to work full-time (40 hrs./week) with reliable transportation to and from work Must be available to work Monday through Friday 8AM to 5PM Must be able to work in the US and must not require sponsorship for employment visa status now or in the future (e.g., FI, H1-B status). Key Requirements and Technology Experience: Key Skills; Experience using Kneat, MS word and in writing method validation or transfer protocols BS Experience and Skills: Required: Incumbent must be proficient with Word, Excel, Power Point, have the soft skills needed to nurture change, as well as, the acuity to use software nuanced to operate in a regulated environment. Generally Requires 8-10 Years Work Experience Kneat experience required A Major in Bio-Medical Engineering, Chemistry or Biology Other Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

QA Validation Specialist Assignment Duration: 11 months Work Schedule: 8 AM - 4:30 PM Work Arrangement: 100% onsite The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation. Background & Context: New role to support a large project in biologics manufacturing. Key Responsibilities: Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance. Provide QA review and approval for commissioning/qualification/validation documents Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions. Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports. Qualification & Experience: B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities. Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices. Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others Excellent problem-solving skills and experience with root cause investigations and CAPA determination Off hours coverage and flexibility may be required

Title: Sterility Assurance Scientist Duration: 6 Month Contract (potential of extension) Responsibilities: The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance contamination control strategies are established. Key Objectives/Deliverables • (Associate/Senior) Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level. • Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to: • Airflow Pattern Testing • Environmental Monitoring Performance Qualifications • Aseptic Process Simulations • Cleaning, Sanitization, and Disinfection • Gowning within GMP Classified Areas • Aseptic Processing Techniques • Contamination Control • Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established. • (Senior) Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established. • (Senior) Lead/assist with support and/or provide technical expertise for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies. • (Senior) Lead/assist with support and/or provide technical expertise for the facility's cleanroom gowning and aseptic technique strategy/program. • (Principal) Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification. • (Principal) Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program: • (EM) Authoring EM Performance Qualifications (EM PQ) and overseeing the execution. • (EM) Evaluating EM data and authoring EM Trend Reports. • (EM) Assist with identifying facility environmental isolates and how to create and maintain environmental isolated cultures. • (APS) Authoring APS protocols and overseeing the execution. • (APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports. • (APS) Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process. • Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination. • Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements.• Lead or provide technical support for root cause investigations associated with sterility assurance programs. • Participate and/or provide technical sterility assurance support during internal and external audits. • Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs. • Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives. Basic Qualifications: • Bachelor's or master's degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline. • Demonstrated understanding and relevant experience of scientific principles required for manufacturing parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing. • (Senior) 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept). • (Principal) 5+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept). Additional Skills/Preferences: • Possess strong interpersonal skills to work cross-functionally within a team. • Possess strong self-management and organizational skills. • Possess strong oral and written communication skills for communicating to colleagues, management, and other departments. • Experience with data analysis and trending. • Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing warehouse, or laboratory areas. • Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities. Additional Information: • Role is Monday through Friday based and will be phased from a project support role to a routine support role as the development facility and processes progress. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or off-hour work may be required. • Tasks may require repetitive motion and standing or walking for long periods of time. • Travel may be required during the project phase for training and implementation of sterility assurance programs. This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Pay $76-$81 per hour On-site Role 1 year extendable contract Medical, Dental, Vision, 401k The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation. Responsibilities and Accountabilities: • Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance. • Provide QA review and approval for commissioning/qualification/validation documents. • Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions. • Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports. Qualifications: • B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility • Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities. • Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices. • Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others • Excellent problem-solving skills and experience with root cause investigations and CAPA determination • Off hours coverage and flexibility may be required

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.

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

Are you interested in being part of an innovative team that supports Westinghouse's mission to provide clean energy solutions? At Westinghouse, we recognize that our employees are our most valuable asset and we seek to identify, attract and recruit the most qualified talent while recognizing and encouraging the value of diversity in the global workplace. About the role: As a Supplier Quality Manager, APx Supply Chain Major Mechanical Equipment (WBS3 Mechanical Modules, WBS6 Cranes, WBS7 Aux Equipment, WBS8 Valves), you will be responsible for management of a multinational work group responsible for Supplier Quality Engineers tasks to ensure externally sourced products meet the quality and technical requirements defined by Westinghouse for Large Structural material to Westinghouse. You will report to the Sr. PPM, Energy Systems and I&C,and be located at our Cranberry Township, PA location. Hybrid Work Schedule. Other WEC location could be considered as well. Key Responsibilities: Provide oversite and direction to a distributed team of Quality engineers and technologists located in America and in Europe. Recruit new talent for long-term our needs including interns/co-ops and new hire engineers and technologists. Ensure resources are trained, qualified, and supporting the Supplier Selection, Assessment and Development of their Quality Program. Coordinate with external partners to ensure suppliers maintain Quality Assurance Programs aligned with nuclear industry standards and contractual obligations. Direct investigations and compliance assessments, verifying adherence to technical specifications, inspection procedures, and non-destructive testing standards. Ensure efficient execution of the Supplier Oversight activities (Witness and Hold Points), during the production process. Ensure best practices, lessons learned, and improvement are achieved in project performance and margins. Prepare and implement development plans. Help develop next generation of engineers to ensure future WEC leadership pipeline. Support development and mentoring of the team to aid in their technical development, project performance and work satisfaction. Provide management team information by collecting, analyzing, and summarizing engineering data and trends. Engage with external customers, partners and WEC senior management. Qualifications: Bachelor's Degree in Engineering required. Mechanical, Civil or Industrial Engineering or related technical degree preferred. Nuclear industry experience, under Safety Related Requirement (e.g NQA-1) 8+ years of leadership experience in roles of growing responsibility including managing engineering or technical teams. Experience managing engineering and quality teams is preferred. We are committed to transparency and equity in all of our people practices. The base salary range for this position, which is dependent upon experience, qualifications and skills, is estimated to be $130,400 to $163,000 per year. No relocation will be provided for this position. #LI-Hybrid Why Westinghouse? Our benefits package is tailored to meet the diverse needs of our employees, while also promoting wellness and career growth. The following are representative of what we offer: Comprehensive Medical benefits which could include medical, dental, vision, prescription coverage and Health Savings Account (HSA) with employer contributions options Wellness Programs designed to support employees in maintaining their health and well-being including Employee Assistance Program providing support for our employees and their household members 401(k) with Company Match Contributions to support employees' retirement Paid Vacations and Company Holidays Opportunities for Flexible Work Arrangements to promote work-life balance Educational Reimbursement and Comprehensive Career Programs to help employees grow in their careers Global Recognition and Service Programs to celebrate employee accomplishments and service Employee Referral Program Westinghouse Electric Company is the global nuclear energy industry's first choice for safe, clean, and efficient energy solutions. We enable our delivery of this vision by living our value system: Safety and Quality Integrity and Trust Customer Focus and Innovation Speed and Passion to Win Teamwork and Accountability While our Global Headquarters are located in Cranberry Township, PA, we have over 11,000 employees working at locations in 19 different countries. You can learn more by visiting Westinghouse is an Equal Opportunity Employer including Veterans and Individuals with Disabilities Get connected with Westinghouse on social media: Twitter | Facebook | LinkedIn| YouTube Employment opportunities may require access to information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.

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

We, at RQ Construction, LLC are looking for Construction Quality Control Managers (CQCM) to join our Field Operations team. Project assignment is located in North Carolina and will require working on an active project on a military base. This particular opportunity is in Camp LeJeune, NC. QC Managers are responsible for planning, coordinating, and implementing a project-specific quality control program, executing its performance according to contract requirements, completing administrative documentation on time, and cultivating customer satisfaction with the client, all in alignment with RQ's Mission, Vision, and Values. Preference will be given to local candidates depending on the project location. Relocation or travel will be required, as the QC Manager role is an on-site position The pay range for this opening is $90-$125k * Ten (10) or more years combined experience (or equivalent) in commercial construction industry as a Superintendent, QC Manager, Project Manager, or Project Engineer required, as well as two years' experience as a QC Manager required * A current USACE CQM for Contractors Certificate is required and RMS/QCS training is preferred (training is available) * Specialty inspection training and licenses/certs highly desired * LEED AP, AP+ or Green Associate (GA) Certificate preferred * Level 1 EM 385-1-1, CRP, First Aid, OSHA 30-hour certifications required. Training can be provided * Computer literacy (Microsoft Office, Outlook, Internet, etc.) required * Specific software literacy (Viewpoint/Vista, RMS/QCS) preferred RQ is headquartered in beautiful Carlsbad, CA, we are a full-service Design-Build company. We offer management of projects throughout the United States, with our field operations' team members who work on location for each of our projects. We specialize in fast-track projects in new commercial construction for both public and private clients, with a primary focus in the Department of Defense market. COMPANY PROFILE: Since 1996, RQC, LLC. has been a leading player in Southern California's robust commercial and governmental Design-Build economy. We now have a national presence with current projects approaching $1B, spanning coast to coast. RQC, LLC is a full service contracting and design firm that specializes in Design/Build projects for both public and private clients, with a primary focus on the Department of Defense. Our mission is "to provide our customers the best built environment while being the first choice of all stakeholders." The firm offers a variety of services including construction, architectural design, trade services, virtual design and construction, and LEED/sustainable design management for projects ranging from $25M to over $250M. RQ's experience includes projects throughout the U.S., as well as internationally at U.S. Naval Base Guantanamo Bay, Cuba and Puerto Rico. The success of this company has been built on three pillars: Quality, Integrity, and Leadership. Our employees work hard as a team, thrive on innovation and remain committed to being the first choice of our clients as well as all other stakeholders. In return we offer an excellent work environment, very competitive compensation, and an outstanding benefits package. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, creed, gender (including gender identity and gender expression), religion (all aspects of religious beliefs, observance or practice, including religious dress or grooming practices) marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition (including cancer or a record or history of cancer, and genetic characteristics), sex (including pregnancy, childbirth, breastfeeding or related medical condition), genetic information, sexual orientation, veteran status, or any other basis or status protected by federal, state, or local law or ordinance or regulation. All candidates considered for hire must provide evidence of identity and U.S. work authorization at the time of hire. Additionally, all candidates must successfully pass a drug screening and commercial criminal background check, including a stricter Department of Defense background check, for access to job site at military base (if applicable for position being hired for).

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.

**Country:** United States of America ** Onsite **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of "U.S. Person" go here. ********************************************************************************************** **Security Clearance:** None/Not Required The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes. This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport. **What You Will Do:** + Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc. + Performs escape management procedures for disclosure of nonconforming hardware + Leads customer audits/assessments as required + Manages customer satisfaction metrics and develops plans to recover and maintain goals + Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts + Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.) **Qualifications You Must Have:** + Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience **or** an Advanced Degree in a related field + In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools. + Experienced and comfortable with customer-facing responsibilities **Qualifications You Must Have:** + 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development. + FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired. + Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA) **What We Offer:** _Some of our competitive benefits package includes: _ + Medical, dental, and vision insurance + Three weeks of vacation for newly hired employees + Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option + Tuition reimbursement program + Student Loan Repayment Program + Life insurance and disability coverage + Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection + Birth, adoption, parental leave benefits + Ovia Health, fertility, and family planning + Adoption Assistance + Autism Benefit + Employee Assistance Plan, including up to 10 free counseling sessions + Healthy You Incentives, wellness rewards program + Doctor on Demand, virtual doctor visits + Bright Horizons, child and elder care services + Teladoc Medical Experts, second opinion program + This position may be eligible for relocation + And more! **Learn More and Apply Now!** Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Our **Avionics** team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today. **WE ARE REDEFINING AEROSPACE.** * Please consider the following role type definitions as you apply for this role. **Onsite:** Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. _Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings._ At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that's redefining aerospace, every day. **_As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote._** The salary range for this role is 101,000 USD - 203,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. _RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._ **Privacy Policy and Terms:** Click on this link (******************************************************** to read the Policy and Terms Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.

GARNEY CONSTRUCTION A Quality Control Manager position in Charlotte, NC is available at Garney Construction. Join our Garney team to manage and support project Quality Management Specialists, ensuring each project is successful. The Quality Control Manager is responsible for the implementation, management, and execution of Quality Management Programs for Federal contracting projects. WHAT YOU WILL BE DOING * Develop and implement project Quality Management Systems to ensure compliance with contract quality standards * Review project CPM schedule to anticipate and request timely submittals * Review project schedules and prepare Government meeting notices to support schedules * Conduct weekly Quality Control meetings * Perform/supervise quality inspections as needed by the project or Project Manager * Provide effective and efficient communication with the Federal Government personnel * Promote Garney's safety programs and procedures to promote a safe working environment WHAT WE ARE LOOKING FOR * 10 years of construction experience, 3 years being Construction Quality Manager experience * Bachelor's Degree in Engineering, Construction Management, or related field * Current USACOE Construction Quality Management for Contractors Certification * EM 385 40 hour and OSHA 30-hour certifications LET'S TALK THE PERKS! * Employee Stock Ownership Plan (ESOP) * 401K Retirement plan * Health, dental, vision and life insurance * Flexible Spending Account (FSA) / Health Savings Account (HSA) * Long-term disability * Wellness program * Employee Assistance Plan * Holidays and PTO * Bonus program CONTACT US If you have questions about the position, please contact Patrick Duque at ************************ . Please include resumes, references, job lists, and any other relevant documentation. Garney Construction and its subsidiaries are committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Garney Construction is a background screening, drug-free workplace. Agency Disclaimer: All vendors must have a signed Garney Construction Agreement, authorized by the Executive Team, to receive payment for any placement. Verbal or written commitments made by anyone other than a member of the Executive Team will not be considered binding. Any unsolicited resumes sent to Garney Construction or submitted to employees outside of the Recruiting Team will be deemed the property of Garney Construction. In such cases, Garney Construction will not be obligated to pay any placement fees. THE BENEFITS OF WORKING AT GARNEY Free medical, prescription, dental, and vision plans ($0 premiums) Virtual doctor visits with no co-pay Shares of company stock at no cost starting your first day 401(k) plan with a 3.5% match Student loan resources Weekly paychecks Paid time off 8 paid holidays Health Savings Account (HSA) with a lump sum and matching contributions Free life insurance & disability policy Free access to healthcare coordinators Counseling sessions with mental health professionals at no cost Access to consultations with legal/financial professionals at no cost Free programs assisting with weight loss, maternity health, prescriptions for chronic conditions, and more 50% employee discount in the Garney apparel store BUILDING SUSTAINABLE FUTURES WITH THE WORLD'S MOST PRECIOUS RESOURCES-WATER AND PEOPLE. EEO - it's the law poster Right to work This organization participates in E-verify Nearest Major Market: Charlotte

🕒 Work Hours: 8:00 AM to 5:00 PM, Monday through Friday 💲 Competitive Compensation Make the Right Connection-Build Your Career with Dixon! Dixon Quick Coupling, a proud division of The Dixon Group is looking for a Quality Control Manager to join our team in Dallas, North Carolina! We are seeking a dynamic leader with a strong background in manufacturing and a proven track record of implementing and leading a Quality Management System (QMS) from its early stages. The ideal candidate is a strategic, self-starting problem-solver who works collaboratively to drive improvement, reduce costs, and deliver high-quality results with precision and purpose. About Us: The Dixon Group is a global, family-owned manufacturing company with a history of over 100 years of operation in the U.S.A. Based in Chestertown, Maryland, with distribution centers located worldwide. The company has a diverse workforce and a strong values-based culture. As an innovator in the hose coupling industry, our mission is to provide real solutions for our customers while fostering a supportive and collaborative work environment. At The Dixon Group, we value the contributions of our Military Veterans and proudly employ our nation's heroes. Veterans are strongly encouraged to apply. 🚚 What You'll Do Take full ownership of the division's Quality Management System (QMS), including creating procedures for raw material acceptance, in-process evaluation, and final product inspection. Lead or conduct investigations and corrective actions for significant defects and customer complaints. Promote and lead cost reduction activities to minimize waste, scrap, and rework, which will directly reduce the business unit's cost of poor quality (COPQ). Maintain and manage quality control instruments and testing equipment. Provide direction and mentorship to Quality Department personnel. Ensure compliance with the QMS by providing training and conducting audits. Regularly report on program progress, investigation findings, root causes, and corrective actions to the Division Leadership Team. 🎯 What We're Looking For Experience: A minimum of 10 years of experience in a manufacturing or production environment, with at least 5 years in a decision-making role. Education: Bachelor's degree in Engineering, Quality Management or Business Administration required. QMS Implementation: Extensive experience in implementing a QMS, especially from the ground up. Certifications: Experience in ISO certified facilities, with a strong preference for candidates with prior ISO 9001 implementation experience. Leadership: Proven ability to lead and motivate teams, with a strong focus on project leadership. Technical Skills: Proficient in relevant software, data analysis, critical thinking, and problem-solving. Problem-Solving: Expertise in conducting investigations and determining root causes and corrective actions. Communication: Excellent communication and interpersonal skills to work effectively with diverse teams. Additional Skills: Six Sigma/Black Belt is a plus. 🌟 What We Offer Medical, dental, and vision insurance for you and your family Competitive salary Bonus programs 401K retirement plan Training opportunities Tuition reimbursement Paid vacation, PTO, and holidays Gym reimbursements, and more! Join us and be a part of a team that values your contributions and supports your goals! The Dixon Group is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices and laws. Accordingly, to the fullest extent required by applicable law, The Dixon Group strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons. The Dixon Group is committed to protecting the privacy rights of its employees and job applicants to the fullest extent required by applicable law. To that end, personal information will be collected solely for those legitimate business purposes recognized by law, and then maintained in a manner consistent with all applicable laws and regulations pertaining to document retention requirements. The Dixon Group does not sell personal information to third parties, and does not share such personal information with third parties except when authorized by law to do so (e.g., in response to a lawful subpoena; mandatory tax reporting; etc.)

Job Title: Quality Control Section Manager Department: Quality Control Section Reports To: Plant Manager The Quality Control Section Manager is responsible for developing, implementing, and overseeing strategies that ensure the quality of products and services. This includes establishing quality control systems, resolving internal and external quality concerns, and managing the department to strengthen company reliability and customer satisfaction. Serving as management representative for all third-party quality certifications, the Quality Control Manager is accountable for maintaining the department budget, advancing continuous improvement efforts, and ensuring product integrity meets or exceeds customer expectations. This position also supports the Plant Manager in meeting overall plant objectives. Key Responsibilities Customer Quality Management Serve as the primary quality contact for OEM and Tier 1 customers. Manage customer audits and submissions for PPAP and APQP with accuracy and timeliness. Respond quickly to customer quality concerns and implement effective corrective actions. Compliance & Certification Prepare the manufacturing operation for third-party certifications, including ISO 9001, IATF 16949, and ISO 14001. Coordinate and manage internal and external audits in collaboration with the Plant Manager as the Corporate Quality Assurance Representative. Lead audit activities for ISO/IATF certifications, review findings, and develop improvement plans. Arrange internal auditor training as necessary. Address audit non-conformities using the management review system. Ensure timely closure of all preventive and corrective actions. Data Analytics & Digitalization Apply statistical tools such as SPC, Cpk, and PPM for monitoring and improving processes. Use advanced data analysis tools (e.g., Minitab, Power BI) for trend analysis and predictive quality insights. Lead digital transformation initiatives within the quality function. Risk Management Implement risk-based thinking aligned with IATF 16949 requirements. Lead FMEA development and maintain robust Control Plans to mitigate potential failures. Sustainability & Regulatory Compliance Support compliance with emerging environmental regulations such as PFAS, REACH, and RoHS. Collaborate on sustainability and carbon-neutral initiatives that impact quality processes. Supplier Quality Management Conduct supplier audits and drive continuous improvement efforts. Ensure suppliers meet quality standards and follow corrective action requirements. Inspection & Control Oversee product inspections, process audits, and traceability systems. Manage calibration and testing processes. Supervise incoming inspection and final inspection functions. Hold authority to stop processing, delivery, or installation of nonconforming products until issues are resolved. Management Responsibilities Assist leadership in developing goals, objectives, and budgets aligned with corporate strategy. Create departmental activity plans to support continuous improvement. Set employee objectives, conduct semiannual performance evaluations, and develop incentive programs for direct reports. Demonstrate strong leadership through cross-functional collaboration and strategic alignment of quality initiatives with business goals. Continuous Improvement Develop and implement training programs for manufacturing personnel on quality standards and third-party certification requirements. Promote initiatives to reduce defects, enhance process capability, and improve customer satisfaction. General Authority Ensure the quality management system is established, implemented, and maintained in accordance with international standards. Report quality system performance to executive management and recommend improvements. Qualifications Bachelor's degree in Engineering or a related field. Minimum of five years of automotive or manufacturing quality management experience. Strong knowledge of IATF 16949, APQP, PPAP, and customer-specific requirements. Proficiency with statistical tools and data analytics platforms (e.g., Minitab, Power BI). Excellent communication and negotiation skills with customers and suppliers. Experience with global quality operations, including international audits and cross-cultural communication, is highly preferred. Skills and Competencies Strong computer proficiency (Word, Outlook, Excel, Power BI). Knowledge of quality control methods (QC Seven Tools, statistical quality control, 5 Whys, etc.). Strong written and verbal communication skills in English. Experience as a Management Representative for ISO/IATF standards. Strong organizational, leadership, and problem-solving abilities. Internal and external auditing experience (Lead Auditor certification preferred). Experience in employee development, coaching, and continuous improvement. Bilingual in English and Japanese is preferred. Physical Requirements Ability to perform extensive computer work. Ability to use small hand tools and handle fasteners. Visual acuity to identify small defects in production materials. Ability to stand, walk, bend, and lift up to 25 lbs. Ability to travel occasionally, sometimes on short notice. Ability to perform hands-on inspections and process evaluations. Safety and Environmental Responsibilities Comply with company safety policies and procedures. Follow ISO 14001 environmental policies and requirements. Wear required personal protective equipment at all times. Report unsafe conditions or safety concerns immediately.