Quality assurance manager jobs in North Carolina - 711 jobs

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

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!

Person will be responsible for taking full control of CQC plan for Sauer on a project in Camp Lejeune, NC. The candidate will be responsible for overall management of the CQC plan and having full authority to act in all QC matters. Essential Functions Capable of coordinating with many Subcontractors Efficient/Able to plan days, weeks in advance Detail driven Skillful communicator with client/subcontractors Able to conduct QCM weekly meeting in a highly professional manner and instill confidence in client in the QC operations Perform/coordinate inspections Upload and manage QC data on a daily basis Perform submittal review functions Proficient completing required daily documentation Qualifications Candidate must have 5 years of combined experience as a Superintendent, Project Manager, Project Engineer and at least 3 years' experience as a QC Manager or degree in Construction Management, engineering with 5 years construction experience and 2 years QCM relative experience. Certificate for "Construction Quality Management for Contractors" from USACE 30 Hour OSHA in construction Excellent knowledge of quality control inspection standards, procedures and applicable codes required Strong verbal and written communication skills Skills/Competencies Job requires the employee to sit, walk, stand, climb, bend/twist at the neck, bend/twist at the trunk, squat/stoop/kneel, reach above head, reach forward, push/pull, lift and carry. Benefits Benefits: Our Competitive Compensation And Benefits Package Includes Outstanding working environment Wellness initiatives Medical Insurance Dental Insurance Flexible spending account Life insurance Accidental death and dismemberment insurance 401(k) with employer contributions Short-term and long-term disability Paid holidays Paid Time Off Job-related training Direct deposit payroll Annual Bonus Per Diem Email Your Resume In Word To Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: kyle.lesser@cybercoders.com Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : KL2-1808604 -- in the email subject line for your application to be considered.*** Kyle Lesser - Recruiting Manager For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. This job was first posted by CyberCoders on 06/28/2024 and applications will be accepted on an ongoing basis until the position is filled or closed. CyberCoders is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.

The Manager, Quality Management Systems (QMS) is responsible for ensuring compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards within a warehouse environment supporting clinical trial supplies. This role leads the implementation, maintenance, and continuous improvement of quality systems to ensure regulatory compliance, operational excellence, and inspection readiness. Essential Duties and Responsibilities Oversee and manage QMS processes, including document control, policy development, and procedure implementation, in alignment with GDP, 21 CFR, and industry standards. Plan, conduct, and manage internal and external audits of warehouse operations to ensure compliance with regulatory requirements, quality guidelines, and standard operating procedures (SOPs). Lead deviation management, including investigations, corrective and preventive actions (CAPAs), change control activities, and risk assessments. Ensure timely vendor and customer qualification and verification activities. Verify accuracy and completeness of quality documentation for all inbound and outbound transactions executed by warehouse operations. Maintain accurate, current, and compliant records within the electronic QMS (eQMS) for all quality-related documentation and activities. Review, approve, and authorize quality-related documents, records, and agreements. Prepare, review, and maintain SOPs, validation documentation, training records, and other quality documents within the eQMS to ensure compliance with regulatory and organizational standards. Support regulatory inspections, internal audits, and customer audits by providing documentation, addressing findings, and ensuring inspection readiness. Monitor QMS performance using metrics and reports to assess effectiveness and identify opportunities for improvement. Develop and deliver training programs for staff on QMS processes, GDP requirements, and regulatory compliance. Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory functions, to resolve quality issues and implement improvements. Train warehouse operations personnel on quality procedures and compliance expectations. Stay current with evolving regulatory requirements and ensure timely incorporation into QMS practices. Conduct annual reviews of SOPs and update processes as required. Ensure all quality and operational documents are maintained in a controlled, secure, and compliant manner. Work Experience Qualifications Minimum of 5 years of experience in a Quality Management Systems role within the pharmaceutical or life sciences industry. Results-oriented professional with a strong customer service mindset and effective communication skills. Experience with SAP and electronic QMS platforms preferred. High attention to detail with professional verbal and written communication skills. Ability to manage multiple priorities and projects simultaneously in a regulated environment. Willingness and ability to travel for audits, meetings, and industry events. Strong time management, organizational, and problem-solving skills. Self-motivated, accountable, and proactive in driving quality initiatives. Proficient in administrative tools, including MS Office and Google Workspace. Excellent written, verbal, and interpersonal communication skills. Masters is preferred.

Title-Quality Coordinator Full Time Role Monday-Friday-Morning Shift About AVL Manufacturing AVL Manufacturing is a global leader in advanced manufacturing solutions, specializing in the design and production of high-quality industrial and engineered systems. With a strong focus on innovation, safety, and continuous improvement, AVL is expanding its manufacturing operations in Charlotte, NC, and is seeking skilled professionals who want to grow with a stable, long-term organization. At AVL, the mantra “We Are One Team” is lived every day. Employees are valued for their hands-on expertise, commitment to safety, and their ability to contribute meaningfully to a collaborative and supportive manufacturing environment. Arrow Workforce Solutions is the exclusive staffing partner supporting hiring for this role with AVL Manufacturing. Overview: We are seeking a skilled and detail-oriented Quality Coordinator - Electrical/Mechanical to ensure our products, systems, and processes meet customer, industry, and company quality standards. This role involves inspecting materials, mechanical components, and electrical systems, maintaining quality records, supporting continuous improvement initiatives, and ensuring compliance with safety and regulatory requirements in a manufacturing environment. Key Responsibilities: Perform inspections on incoming materials, welds, in-process work, final products, and electrical systems to ensure compliance with drawings, blueprints, and industry standards. Install, maintain, and test electrical wiring, switchgear, motors, transformers, lighting, and other industrial electrical components. Conduct equipment testing for continuity, voltage, current, resistance, and mechanical tolerances. Knowledge on Non-Conforming Reports Maintain calibration records and manage non-conformance reports (NCRs). Collect, document, and report quality data for audits, projects, and process improvements. Support troubleshooting, corrective actions, and problem-solving for mechanical and electrical issues. Apply Non-Destructive Testing (NDT) methods such as MPI and LPI when required. Assist with ISO quality systems, including documentation, audits, and continuous improvement initiatives. Provide feedback to engineering teams regarding design improvements and document change requests. Occasionally maintain or modify basic PLC programs as required. Communicate effectively with cross-functional teams regarding quality issues and updates. Perform on-site installation, servicing, and warranty repairs for customer products. Maintain a clean, safe, and professional work environment in compliance with OSHA and safety standards. Qualifications: Diploma in Mechanical, Electrical, or Industrial Technology (preferred). Licensed Journeyman or Industrial Electrician (for electrical responsibilities). 3-5+ years of experience in a manufacturing or industrial environment, preferably ISO-certified. Hands-on experience with AWS welding inspection and fabrication processes (mechanical) and industrial electrical systems. Knowledge of ISO 9001, AWS D1.1/CSA W47.1, AWS D1.1/W59, and NEC regulations. Basic PLC programming knowledge is a plus. Strong ability to read and interpret engineering drawings and schematics for both mechanical and electrical systems. Proficient in Microsoft Office and ERP systems. Ability to lift up to 50 lbs and travel across North America (valid passport & driver's license required). Skills & Attributes: Solid understanding of OSHA safety requirements and workplace safety. Strong problem-solving, organizational, and analytical skills. Effective communication skills and ability to work collaboratively with teams. Self-motivated, adaptable, and capable of multitasking in a fast-paced environment. Committed to delivering quality work on time and within budget. Maintains a clean, safe, and professional work environment.

The Quality Assurance Operations Manager supports the Director of Quality Assurance to ensure compliance to regulations and internal procedures while meeting company goals and client requirements. The QA Operations staff reviews all data prior to release and is responsible for the quality review of associated systems (e.g. OOS investigations, SOPs, validation protocols/reports). PRIMARY DUTIES AND RESPONSIBILITIES Provide direct oversight to QA operations staff. Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews. Review, approve Laboratory test data and reports. Prepare and approve certificates of Analysis. Support activities related to internal and external audits. Represent site Quality group during Client and regulatory audits. Collaborate with Laboratory management to support company goals. Works directly with laboratory operations, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner. Creates and reports metrics for quality system key performance indicators and provides quality and compliance assessments to senior management as required and contribute to strategic direction or initiatives to achieve organizational effectiveness. Actively participate in operational excellence programs/initiatives. Review laboratory protocols and reports for accuracy and compliance to cGMP's, as applicable. Site system owner for OOS, complaint, and deviation programs. Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation. Completes required actions for identified corrective/preventive actions for the Quality department. REQUIREMENTS & QUALIFICATIONS Qualification include a Bachelor's degree in a related discipline with 6+ years of QA/QC experience in the pharmaceutical industry and 2+ years of mentoring and supervising direct reports. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production. Experience in root cause analysis, risk management, and corrective/preventative action development. DESIRED SKILLS Enthusiastic, team player, collaborative across all departments to achieve the common goals. Ability to focus on internal processes while maintaining focus on client needs. Ability to work in a fast paced, dynamic environment. Experience with LEAN implementation. Familiarity with laboratory information management systems. ISO 17025 or 9001 experience and knowledge. Demonstrated ability to foster a Quality Culture across the organization. Team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.

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 at APx Supply Chain Turbine Major Equipment, you will manage a multinational work group. This group is responsible for Supplier Quality Engineers' tasks, ensuring that externally sourced products meet the quality and technical requirements defined by Westinghouse. Specifically, these requirements apply to Large Structural material supplied to Westinghouse. You will report to the Delivery Stream WBS Directorand be located at our Cranberry Township, PA location. Hybrid Work Schedule. We could consider other WEC locations 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. Achieve best practices, lessons learned, and improvement 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 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

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

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. 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.

Bendel Tank and Heat Exchanger, LLC, a division of TransTech Group, LLC, is a leading manufacturer of custom Carbon Steel, Stainless Steel, and Nickel Alloy vessels per ASME, API, TEMA, and UL specifications. Having been in business for over 50 years, Bendel serves several industries including: chemical, petrochemical, pharmaceutical, and industrial food manufacturing. Bendel has a strong company culture built on a family atmosphere where success is defined by the impact on the lives of our stakeholders. Position Summary We are seeking a strategic Quality Control Manager to spearhead our quality assurance programs within a high-volume metal manufacturing environment. This leadership role is responsible for ensuring rigorous compliance with international regulatory standards and client specifications. The successful candidate will collaborate with Engineering and Production teams to drive a culture of continuous improvement, oversee end-to-end inspection frameworks, and serve as the primary liaison for technical audits and certifications. Tasks & Responsibilities Project Documentation & ITPs: Develop and interpret detailed Inspection Test Plans (ITP) and comprehensive project data packages to ensure seamless coordination with customer inspectors and adherence to contract specifications. Quality Governance: Develop and optimize comprehensive QC standards and protocols aligned with engineering specifications and regulatory mandates. Regulatory Compliance: Manage the integrity of quality documentation, manuals, and filing systems to ensure audit-readiness at all times. Technical Inspection: Execute precision inspections of raw materials and verify fabrication accuracy against complex engineering schematics. Weld Integrity: Perform visual and liquid penetrant weld inspections; maintain meticulous traceability records, weld maps, and shop travelers. Certification Oversight: Administer welder qualification testing and maintain up-to-date performance records. Audit Leadership: Coordinate and lead Authorized Inspector (A.I.) audits and National Board reviews, ensuring zero-defect reporting. Testing & Validation: Supervise hydrostatic testing and conduct final quality validation of finished products prior to global shipment. Supply Chain Quality: Conduct comprehensive quality audits of vendors and subcontractors to ensure material and service consistency. Continuous Improvement: Identify systemic quality variances and implement Root Cause Analysis (RCA) and Corrective Actions (CAPA). Mentorship: Provide technical training and QC guidance to fabrication and welding teams to elevate shop-floor performance. Competencies Certifications: Active AWS CWI required; additional API or NACE certifications highly preferred. Technical Expertise: Mastery of ASME (Sections I, VIII, IX), API, and AWS codes and regulatory frameworks. Skills: Proficiency in reading complex blueprints, interpreting NDT results, and managing multi-stage fabrication workflows. Education & Experience: A Bachelor's degree in Engineering or a related field, or 10+ years of progressive leadership experience in heavy metal fabrication quality control. Benefits Designed to Work for You: Free HSA health plan or traditional PPO 401(k) with generous company match (Safe Harbor) Dental, vision, and optional coverage like accident & critical illness insurance HSA and FSA accounts to save on healthcare costs Company-paid Life, Long Term Disability, and AD&D insurance Confidential support for mental health, family matters, legal concerns, and more through our Employee Assistance Program Discounts on gyms, shopping & entertainment Health benefits kick in fast - first of the month after 30 days Time Off We offer a variety of paid time off options to support rest, wellness, and personal needs: Paid Time Off Paid Holidays Bereavement Leave This organization 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. 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. #Bendel

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).

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.

Company Information Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Job Overview Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines. Responsibilities Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions. Qualifications/Skills Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills. Track record of successfully applying high level judgment in a variety of complex and unprecedented situations. Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. Ability to coach and develop staff and to transfer job knowledge and skills. Ability to integrate input/data from diverse sources and create new and innovative solutions. Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects. Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations. Exposure to broader analytical techniques (i. e. , beyond just USP compendial testing). Education, Experience & Licensing Requirements BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals. Position also requires visual acuity, talking, writing, and typing. BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions.

🕒 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.)

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

The Quality Control Manager provides leadership, coordination, guidance, technical expertise in all areas of quality. The QCM is responsible for the overall daily operations of quality. This position develops and administers quality related policies, procedures, techniques, initiatives, to ensure that all quality policies and practices are followed consistently on the project. The QCM is responsible for the overall daily operations of quality. Requirements In-depth knowledge of the Construction Standards and Best Practices Working knowledge of the International Building Code Knowledge and experience of diverse project type Ability to delegate tasks to others and supervise performance Excellent analytical skills Very organized and systematic in thinking and processes Computer skills using Procore, Viewpoint, SharePoint, MS Office Associate or bachelor degree in Quality Management, Construction Management, Engineering or related area Minimum of 6 years of construction experience as a Quality Control Manager Essential Job Duties Works with Project Manager, Superintendents, and subcontractors in developing processes and procedures that effectively accomplish the goal of 100% compliant work that exceeds expectations Collaboration among project team and subcontractors Acts as an advocate by maintaining good corporate ethics and promoting quality, at every opportunity, as a core value of the organization Maintains active relationships with engineers, consultants and industry association Assists teams with developing a project specific quality management plan Supports and follows up to ensure that project teams are following their project specific quality management plan Builds and maintains system templates for various DFOW activities conducted Prepare DFOW for project, as required in Quality Management Plan Participates in project meetings Conducts site visits and inspections of work in place Assists teams with plan and constructability reviews Read and understand specifications, reference codes and standards Review and interpret contract drawings Provides training and coaching for project team members to identify key project risks, related to quality Assist team with risk prevention planning and follow up Works closely with the Quality and Construction Science Department to ensure that we are utilizing advancements in technology to support operational excellence and reduce risk on projects Act independently as CQCM while coordinating all QC functions so as not to delay construction scheduling Determine, communicate, and document deficiencies and ensure they are corrected in a timely manner (NCR Log) Maintain current records providing factual evidence that required quality control activities and / or test have been performed Identifies and resolves problems in a timely manner, gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations: uses reason even when dealing with emotional topics Review shop drawings and submittals for conformance with project specifications and contract requirements Initiate Three Phase Inspection process. Conduct daily observations to ensure that all Three Phases of Inspection are undertaken and implemented as designed and document all results. Examine the work area to assure that all required work has been completed and is in compliance with the contract requirements and resolve any differences Conduct and Chair Preparatory Meetings Chair and document weekly QC meetings with internal and external stakeholders (Team and subcontractors quality representatives) and external team members Verify and document that all matters received for the project are in conformance with the approved submittal, are handled and stored appropriately, and are acceptable for use Oversee daily and weekly QC/QA reports that reinforce activities that are being constructed in conformance with established standards Benefits Includes PTO 401K match Full medical, vision, and dental benefits vehicle allowance Per Diem based on project location Lucrative bonus potential Email Your Resume In Word To Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: kyle.lesser@cybercoders.com Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : KL2-1813826 -- in the email subject line for your application to be considered.*** Kyle Lesser - Recruiting Manager For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. This job was first posted by CyberCoders on 08/05/2024 and applications will be accepted on an ongoing basis until the position is filled or closed. CyberCoders is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.

The Quality Systems Specialist is responsible for supporting the Quality Management System (QMS), including GxP document management and training programs. This role ensures compliance with regulatory standards, maintains the integrity of documentation systems, and collaborates with cross-functional teams to support document and training needs. Essential Duties GxP Document Management Collaborate cross-functionally to generate workflow status reports and support document owners with new document creation and revisions. Review procedural documents for compliance with formatting, metadata, and applicable standards. Initiate periodic review workflows. Serve as workflow owner as needed. Assist document owners in ensuring proper GxP records management. Create document reports to support business processes, including periodic review and stagnant draft reports. Generate document owner, workflow owner, and task owner reports to support offboarding activities and transfer ownership as appropriate. Training Program Support Generate training reports and distribute upcoming and overdue training notifications. Initiate training assessment forms for managers of new personnel. Create learner roles, training requirements, and curricula within the training management system. Quality Management System Support Schedule and facilitate initial and status meetings. Route forms for electronic signature and maintain tracking logs. Upload completed forms into the document management system. Audits and Inspections Prepare for and participate in internal and external audits related to document control and quality systems. Skills & Education Requirements Bachelor's degree in Life Sciences or a related field, or an Associate degree with relevant work experience. Minimum of 5 years of document control experience. Proficiency with electronic document management systems (e.g., Veeva QualityDocs). Experience supporting gene and cell therapy products. Prior experience in a startup or fast-paced environment. Demonstrated integrity, accountability, and strong teamwork skills.

Quality Coordinator - Electrical/Mechanical Onsite-Direct Hire-Morning Hour+benifits About AVL Manufacturing AVL Manufacturing is a global leader in advanced manufacturing solutions, specializing in the design and production of high-quality industrial and engineered systems. With a strong focus on innovation, safety ,and continuous improvement, AVL is expanding its manufacturing operations in Charlotte, NC, and is seeking skilled professionals who want to grow with a stable, long-term organization. At AVL, the mantra “We Are One Team” is lived every day. Employees are valued for their hands-on expertise, commitment to safety, and their ability to contribute meaningfully to a collaborative and supportive manufacturing environment. Arrow Workforce Solutions is the exclusive staffing partner supporting hiring for this role with AVL Manufacturing. Overview: We are seeking a skilled and detail-oriented Quality Coordinator - Electrical/Mechanical to ensure our products, systems, and processes meet customer, industry, and company quality standards. This role involves inspecting materials, mechanical components, and electrical systems, maintaining quality records, supporting continuous improvement initiatives, and ensuring compliance with safety and regulatory requirements in a manufacturing environment. Key Responsibilities: Perform inspections on incoming materials, welds, in-process work, final products, and electrical systems to ensure compliance with drawings, blueprints, and industry standards. Install, maintain, and test electrical wiring, switchgear, motors, transformers, lighting, and other industrial electrical components. Conduct equipment testing for continuity, voltage, current, resistance, and mechanical tolerances. Maintain calibration records and manage non-conformance reports (NCRs). Collect, document, and report quality data for audits, projects, and process improvements. Support troubleshooting, corrective actions, and problem-solving for mechanical and electrical issues. Apply Non-Destructive Testing (NDT) methods such as MPI and LPI when required. Assist with ISO quality systems, including documentation, audits, and continuous improvement initiatives. Provide feedback to engineering teams regarding design improvements and document change requests. Occasionally maintain or modify basic PLC programs as required. Communicate effectively with cross-functional teams regarding quality issues and updates. Perform on-site installation, servicing, and warranty repairs for customer products. Maintain a clean, safe, and professional work environment in compliance with OSHA and safety standards. Qualifications: Diploma in Mechanical, Electrical, or Industrial Technology (preferred). Licensed Journeyman or Industrial Electrician (for electrical responsibilities). 3-5+ years of experience in a manufacturing or industrial environment, preferably ISO-certified. Hands-on experience with AWS welding inspection and fabrication processes (mechanical) and industrial electrical systems. Knowledge of ISO 9001, AWS D1.1/CSA W47.1, AWS D1.1/W59, and NEC regulations. Basic PLC programming knowledge is a plus. Strong ability to read and interpret engineering drawings and schematics for both mechanical and electrical systems. Proficient in Microsoft Office and ERP systems. Ability to lift up to 50 lbs and travel across North America (valid passport & driver's license required). Skills & Attributes: Solid understanding of OSHA safety requirements and workplace safety. Strong problem-solving, organizational, and analytical skills. Effective communication skills and ability to work collaboratively with teams. Self-motivated, adaptable, and capable of multitasking in a fast-paced environment. Committed to delivering quality work on time and within budget. Maintains a clean, safe, and professional work environment.