Quality assurance specialist jobs in Raleigh, NC - 282 jobs

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.

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

is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department. JOB RESPONSIBILITIES: Performs compliance review on the following records: release, in-process, and stability data. Responsible for the review and approval of method qualifications and validations Responsible for the review and approval of deviations and laboratory investigations. MINIMUM REQUIREMENTS: BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Be able to sit for long periods of time. Ability to lift 20 pounds. Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

AirClean Systems Job Title : QA Manager Department or Division : Quality Reports To : CTO Written By : Kendall Ashe JOB TASKS, DUTIES, AND RESPONSIBILITIES The QA Manager is responsible for helping to execute and improve the Quality Management System to AirClean Systems' requirements. The QA Manager heavily participates in the company's production activities, ensuring the in-process QC and final QC is done correctly on all equipment manufactured. The QA Manager also runs the non-conforming material reports (NCMR) program including analysis of trends and determination of the need for corrective and preventive actions (CAPA). All calibrated equipment and calibration records go through the Quality department to ensure accuracy and availability. The QA Manager also signs off on Engineering Change Orders (ECO) to ensure accuracy and any updates to products have the correct quality control checks in place. In addition, the QA Manager collaborates with the different departments to ensure the company maintains its quality system. JOB DUTIES: Helps execute and improve the Quality Management System. Daily audits of in-process QC and final QC checks to ensure product quality. Trains production and QC employees on proper techniques. Keeps the calibration records on file and reviews/approves third party calibrations performed. Helps ensure Engineering Change Orders actually capture changes and quality control checks are updated accordingly. Reviews non-conforming material reports created by the company, investigates, determines root cause, implements corrections and corrective actions, verifies effectives, and ensures timely closures. Starts CAPAs when needed and brings them through the entire CAPA process as well. Creates, audits, and revises current QC and build procedures and work instructions. Ensures that only repaired units passing final acceptance testing leave the company for customer use. Performs other quality duties as required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. MINIMUM QUALIFICATIONS A four-year engineering degree. Excellent written and oral communication skills. Strong Documentation skills. Must have experience writing procedures and work instructions. Ability to be both hands on and to lead. Strong analytical and problem-solving skills, including solid understanding of electromechanical troubleshooting 5+ years of broad quality system/regulated environment experience. PREFERRED QUALIFICATIONS ASQ Certification or other quality certifications are desirable. ISO 9001 quality system experience Accountabilities High quality products are produced by the factory. In-process and QC and final QC is executed thoroughly and correctly. Timely execution and closure of CAPAs and NCMRs. Calibrated Equipment is calibrated on-time, on a schedule, and available to production, service, and quality when needed. Robust QC procedures and training on QC processes. Communication and relationship with other departments is one of mutual respect and cooperation. The Quality Management System is improved over time. LOCATION This position will be based at our Creedmoor, NC office. Terms of employment This is a full-time, salaried, exempt position. HOURS The general hours shall be Monday - Friday, 8:00am to 5:00pm with an hour break for lunch. Work Environment Work is regularly performed in office and warehouse environments. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is frequently required to sit. The employee is occasionally required to stand and/or walk. The employee must occasionally lift, carry, push or pull up to 40 pounds. Travell Minimal travel may be required. BENEFITS Compensation package includes health insurance, dental insurance, vision insurance, short term disability, life insurance and Teladoc following an introductory period. The Company offers a 401K plan with employer contribution. The Company also offers paid time off and paid holidays. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

The Associate Quality Assurance Manager supports The Upper Deck Company's business units by assisting in the oversight of the Shipping and Quality Assurance departments. This position is ideal for a motivated, detail-oriented professional with strong organizational skills, leadership potential, and experience using project management and data analytics tools to improve workflow and performance. Working closely with the Quality Assurance Manager, this role helps ensure that every product meets Upper Deck's high standards for quality and accuracy while supporting the continued growth and development of team members. ESSENTIAL DUTIES AND RESPONSIBILITIES The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned Support the daily operations of the Shipping and QA departments, maintaining focus on accuracy, efficiency, and on-time project completion. Supervise QA and Shipping team members, providing coaching, feedback, and assistance with problem-solving. Use project management software (e.g., Asana, Monday, Smartsheet) to organize priorities, track progress, and communicate updates. Generate and interpret data reports and quality metrics to identify areas for improvement, reduce errors, and support decision-making. Collaborate with Project Coordinators, Talent Relations, and Brand Management teams to resolve discrepancies and maintain alignment across departments Support continuous improvement initiatives and standard operating procedure (SOP) development. Take initiative in identifying process improvements and helping implement new tools or methods that enhance quality and efficiency. INTERACTION This position will interact closely with the Quality Assurance Manager, Talent Relations, Project Managers, Project Coordinators. SUPERVISORY RESPONSIBILITIES Supervisory responsibilities for Boxing, QA, Shipping Clerks. EDUCATION/YEARS EXPERIENCE Bachelor's degree in business management, Operations, or a related field, or equivalent work experience. 3-5 years of experience in project coordination, operations, or quality assurance. Demonstrated success in managing teams and improving performance through data analytics and technology-based solutions. Experience using project management software and working with data reporting tools. 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. KNOWLEDGE, SKILLS AND ABILITIES Proficient in project management software (e.g., Asana, Monday, Smartsheet) and data visualization tools (e.g., Excel, Power BI, Tableau). Strong analytical, problem-solving, and troubleshooting abilities with a data-focused mindset. Excellent communication and interpersonal skills for cross-departmental collaboration. Highly organized with the ability to manage multiple high-priority initiatives simultaneously. Self-motivated leader with a hands-on approach and professional demeanor. Strong commitment to quality, accuracy, and continuous improvement.

EchoPark Automotive is one of the fastest growing brands within the automotive industry. We are building a business based on doing things the right way. From the way we treat our guests, take pride in our work and share opportunities for our employees to grow as we grow. We are proud of what we're doing here and would love to tell you about our opportunities! Job Description EchoPark Automotive is hiring Customer Service Representatives for our location in Cary, NC! As a Customer Service Representative, which we call Document Specialists, you will play an important role in the smooth and friendly guest experience at our store. If you're a self-sufficient, resilient person who enjoys working in a fast-paced, fun environment, then we're looking for you. As a Document Specialist, you will be responsible for accurate and timely execution of the financial documentation process. What You'll Do: Assist with the final steps of the purchase process Provide accurate and timely completed paperwork for successful processing Check all paperwork for correct title, lien information, taxes, etc. Verify insurance, trade payoffs and obtain deposits What We're Looking For: Demonstrated customer service and attention to detail Experience in a retail environment Be transparent Take the high road Willingness to learn Take ownership Celebrate small successes What We Offer: $36,000 - $50,000 based on experience with monthly bonus opportunities Health, Dental and Vision Insurance 401k with 4% company match Paid vacation Access to leadership and personal development programs Casual dress Additional Information All your information will be kept confidential according to EEO guidelines.

PT Quality Assurance Associate (Janitor/Custodian)

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

Quality Assurance Specialist • Preparing and implementing quality assurance policies and procedures • Performing routine inspections and quality tests • Identifying and resolving workflow and production issues • Meet with and review all workflow and production issues with Regulatory/Compliance Manager weekly/monthly • Meet with and review all workflow and production issues with department employees • Provide additional training where and when needed Responsibilities • Ensure that standards and safety regulations are observed. • Address and discuss issues and proposed solutions with all department management teams and Regulatory/Compliance Manager • Document quality assurance activities and create audit reports. • Make recommendations for improvement. • Create training materials and operating manuals to be approved by Regulatory Compliance Manager • Maintain and update all manuals according to any and all regulatory changes. Requirements and skills • Proven work experience as a Quality Assurance Specialist or similar role • Working knowledge of tools, methods and concepts of quality assurance • Solid knowledge of relevant regulatory standards • Excellent communication skills, both verbal and written • Excellent data collection and analysis skills • Excellent Mathematical skills • Strong attention to detail • Relevant training and/or certifications as a Quality Assurance Specialist Benefits: • Comprehensive benefits (medical, vision, and dental insurance) • 401K plan • PTO and “dream” days • Company events • Education Reimbursement

At Labcorp, you are part of a journey to accelerate life-changing healthcare breakthroughs and improve the delivery of care for all. You'll be inspired to discover more, develop new skills and pursue career-building opportunities as we help solve some of today's biggest health challenges around the world. Together, let's embrace possibilities and change lives! **Document Specialist I (Inventory Production) (On-Site Graham NC)** Labcorp is seeking an Document Specialist to join our team in our Revenue Cycle Management Division! This Document Specialist is responsible for processing secondary claims to private and government payers using the billing system. **RESPONSIBILITIES** + Able to open/sort correspondence as it comes from the post office + Complete and print appeal packages from mPower for mailing + Verify scanned images electronically through AnyDoc + Research control numbers on EOB's using the Labcorp billing system + Route electronic faxes in Any Doc to the desired queues for processing + Communicate any issues within the department to Management + Ability to function comfortably in a fast paced environment where change is a constant + Log/count inventory daily + Resolve issues quickly + Update management on suggestions, feedback and process improvements. + Able to work independently and as a team + Able to work on inventory that is repetitive + Completely and accurately meets established productivity/quality goals + Ability to cross-train on multiple functions + An understanding of bad addresses + Performs required Lean activities (Go Meetings, 5S, etc.) according to established expectations. **REQUIREMENTS** + Requires a High School Diploma or equivalent required + Minimum one year work experience required + Previous accounts receivable, billing, office administration, data entry work experience strongly preferred + Healthcare experience strongly preferred **_Why should I become an Document Specialist at Labcorp?_** + Generous Paid Time off! + Medical, Vision and Dental Insurance Options! + Flexible Spending Accounts! + 401k and Employee Stock Purchase Plans! + No Charge Lab Testing! + Fitness Reimbursement Program! + And many more incentives! **Application Window Closes: 12-25-2025** **Pay Range: $** **17.75 - $21.00 per hour** All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data **Shift: Mon - Fri, 8am - 5pm EST** **Benefits:** Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here (************************************************************** . **Labcorp is proud to be an Equal Opportunity Employer:** Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. **We encourage all to apply** If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (**************************************************** or contact us at Labcorp Accessibility. (Disability_*****************) For more information about how we collect and store your personal data, please see our Privacy Statement (************************************************* .

Job Title: Document Management SpecialistJob Description We are seeking a dedicated Document Management Specialist to support our CMC Development team focusing on Records Room and Regulated Documentation. This role involves ensuring the efficient operation and sustainability of our document management systems. Responsibilities + Operate and sustain document management systems (DCM and PRM). + Organize and index regulated documentation, both digital and physical. + Execute periodic inventories and preservation activities in the Records Room. + Ensure compliance with internal and external regulations. + Prepare reports, presentations, and meeting materials related to regulated documentation workflows. Essential Skills + Proficiency in document management systems. + Experience with regulated documentation. + Strong understanding of compliance and regulatory requirements. Additional Skills & Qualifications + Expertise in documentation management. Work Environment This is a full-time position, working 40 hours per week on site in Clayton, Monday through Friday, from 8:30 AM to 5:00 PM ET. There is limited flexibility for early or late hours during audits, inventories, or peak routing periods. Occasional remote administrative tasks are acceptable when on-site work is not required for physical tasks. Job Type & Location This is a Contract position based out of Clayton, NC. Pay and Benefits The pay range for this position is $20.00 - $20.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Clayton,NC. Application Deadline This position is anticipated to close on Jan 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Education & Qualifications Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly related experience. Experience in Change Control, CAPA, VAPA EV, Deviations, and Documentation handling. Fully Bilingual (Spanish & English) Available for rotative shifts Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Job DescriptionSalary: 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 cGMPs, 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 Bachelors 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.

We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI's values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us! Position Responsibilities: Be an on-the-floor quality partner working with the manufacturing team during operations Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues Conduct QA walkthroughs Participate in safety walkthroughs Participate in process improvements Attend relevant meetings in support of manufacturing operations Review electronic batch records and logbooks Provide feedback on facility response for unplanned events Other tasks and projects as assigned Work 12-hour shifts (2-2-3 schedule, day shift) Position Qualifications: MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. MQA Specialist II Associate degree / bachelor's degree strongly preferred or appropriate years of experience (approximate 3-5 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Ability to support internal and external audits. Demonstrated ability to train employees on Quality subjects. Ability to track and trend department metrics Salary Ranges: MQA Specialist I: $54,000 - $74,300 MQA Specialist II: 66,966 - 92,077 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training. PT Quality Assurane Associate Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law. If you have a disability and require assistance in the application process, please contact our Recruiting Department at ***********************

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.

Job Description Quality Assurance Specialist • Preparing and implementing quality assurance policies and procedures • Performing routine inspections and quality tests • Identifying and resolving workflow and production issues • Meet with and review all workflow and production issues with Regulatory/Compliance Manager weekly/monthly • Meet with and review all workflow and production issues with department employees • Provide additional training where and when needed Responsibilities • Ensure that standards and safety regulations are observed. • Address and discuss issues and proposed solutions with all department management teams and Regulatory/Compliance Manager • Document quality assurance activities and create audit reports. • Make recommendations for improvement. • Create training materials and operating manuals to be approved by Regulatory Compliance Manager • Maintain and update all manuals according to any and all regulatory changes. Requirements and skills • Proven work experience as a Quality Assurance Specialist or similar role • Working knowledge of tools, methods and concepts of quality assurance • Solid knowledge of relevant regulatory standards • Excellent communication skills, both verbal and written • Excellent data collection and analysis skills • Excellent Mathematical skills • Strong attention to detail • Relevant training and/or certifications as a Quality Assurance Specialist Benefits: • Comprehensive benefits (medical, vision, and dental insurance) • 401K plan • PTO and “dream” days • Company events • Education Reimbursement

At Labcorp, you are part of a journey to accelerate life-changing healthcare breakthroughs and improve the delivery of care for all. You'll be inspired to discover more, develop new skills and pursue career-building opportunities as we help solve some of today's biggest health challenges around the world. Together, let's embrace possibilities and change lives! Document Specialist I (Inventory Production) (On-Site Graham NC) Labcorp is seeking an Document Specialist to join our team in our Revenue Cycle Management Division! This Document Specialist is responsible for processing secondary claims to private and government payers using the billing system. RESPONSIBILITIES Able to open/sort correspondence as it comes from the post office Complete and print appeal packages from mPower for mailing Verify scanned images electronically through AnyDoc Research control numbers on EOB's using the Labcorp billing system Route electronic faxes in Any Doc to the desired queues for processing Communicate any issues within the department to Management Ability to function comfortably in a fast paced environment where change is a constant Log/count inventory daily Resolve issues quickly Update management on suggestions, feedback and process improvements. Able to work independently and as a team Able to work on inventory that is repetitive Completely and accurately meets established productivity/quality goals Ability to cross-train on multiple functions An understanding of bad addresses Performs required Lean activities (Go Meetings, 5S, etc.) according to established expectations. REQUIREMENTS Requires a High School Diploma or equivalent required Minimum one year work experience required Previous accounts receivable, billing, office administration, data entry work experience strongly preferred Healthcare experience strongly preferred Why should I become an Document Specialist at Labcorp? Generous Paid Time off! Medical, Vision and Dental Insurance Options! Flexible Spending Accounts! 401k and Employee Stock Purchase Plans! No Charge Lab Testing! Fitness Reimbursement Program! And many more incentives! Application Window Closes: 12-25-2025 Pay Range: $ 17.75 - $21.00 per hour All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data Shift: Mon - Fri, 8am - 5pm EST Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

Job Title: Document Management SpecialistJob Description We are seeking a dedicated Document Management Specialist to support our CMC Development team focusing on Records Room and Regulated Documentation. This role involves ensuring the efficient operation and sustainability of our document management systems. Responsibilities * Operate and sustain document management systems (DCM and PRM). * Organize and index regulated documentation, both digital and physical. * Execute periodic inventories and preservation activities in the Records Room. * Ensure compliance with internal and external regulations. * Prepare reports, presentations, and meeting materials related to regulated documentation workflows. Essential Skills * Proficiency in document management systems. * Experience with regulated documentation. * Strong understanding of compliance and regulatory requirements. Additional Skills & Qualifications * Expertise in documentation management. Work Environment This is a full-time position, working 40 hours per week on site in Clayton, Monday through Friday, from 8:30 AM to 5:00 PM ET. There is limited flexibility for early or late hours during audits, inventories, or peak routing periods. Occasional remote administrative tasks are acceptable when on-site work is not required for physical tasks. Job Type & Location This is a Contract position based out of Clayton, NC. Pay and Benefits The pay range for this position is $20.00 - $20.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Clayton,NC. Application Deadline This position is anticipated to close on Jan 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.