Quality assurance specialist jobs in Durham, NC

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.

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.

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

ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 8:30 AM - 5 PM KEY RESPONSIBILITIES Batch Review and disposition: Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. Review and approve Master Batch Records. Perform the review of records and determine disposition of: Medical Devices Packaged/Labeled Medical Devices Clinical Product Investigations and CAPAs. Perform the review of Testing Specifications. Validation Coordinate and monitor validation activities. Provide support during regulatory inspections of GMP Contractors and LCI facilities. Assist in performing inspection readiness activities. Review Quality Agreements. Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. Provide updates to Manager, BioMed Operations. QUALIFICATIONS Bachelor's Degree in a life science-related discipline or equivalent work experience. Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. Experience in working with third-party contract manufacturers, laboratories, and packagers. Knowledge of pharmaceutical industry regulatory requirements. High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. Ability to exercise strong risk-based business judgment. Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally Good investigation and monitoring skills. Current knowledge of QC testing methods. Attention to detail and implementation of good documentation and GMP processes is essential. Excellent communication skills required and must be computer literate. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. Why LCI? Purpose-driven company driven by principles, not profit Reach your highest potential: upward mobility, rewarded through hard work Competitive salary and compensation Basic Life Insurance at no cost to the employee 401(k) with match and Surplus-Sharing Plans Health, Dental, and Vision Insurance Ten paid holidays annually Paid Time Off (PTO) On-site Health and Wellness program Employee Assistance Program (EAP)

Join Us in Shaping the Future of Regulatory Services. knoell is one of the leading global service providers in regulatory registration, clinical development, and product development support. As a family-owned business, we take pride in our commitment to the highest standards and believe that people are at the heart of our success. With our team of scientific and regulatory experts and an extensive network of partners, we ensure reliable solutions that address our clients' global business needs right from the start. At knoell, we are guided by our core values of commitment, reliability, excellence and diversity. Are you someone who thrives in a collaborative environment? Do you take pride in delivering high-quality results and upholding excellence in everything you do? At knoell, we are passionate about embracing diverse perspectives, knowing that this fuels innovation and strengthens our impact. If you're ready to be part of a team that values these principles, we want to hear from you! Think Globally. Act Locally. The Quality Assurance Auditor is responsible for auditing facilities and studies to ensure compliance with Good Laboratory Practice (GLP) standards and related documentation for regulatory submissions. This role involves inspecting and reviewing testing facilities, study protocols, study conduct, raw data, and draft study reports in alignment with GLP principles and applicable test guidelines. The Quality Assurance Auditor prepares inspection reports and verifies at finalization that all findings have been appropriately addressed. Upon completion, the Auditor issues and signs a Quality Assurance Statement. The position requires strong expertise in agricultural practices, analytical chemistry, and comprehensive knowledge of Good Laboratory Practice (GLP) regulations. Inspect testing facilities to ensure frameworks are in place for studies to meet GLP requirements Audit studies supporting the authorization of crop protection products, including: Reviewing draft protocols for GLP compliance and alignment with test guidelines Inspecting raw data for accuracy and integrity Observing the in-life phase of studies during conduct Reviewing draft study reports for accuracy, completeness, and compliance Preparing inspection reports and verifying corrective actions have been addressed Work independently and audit complex studies Act as a key contact for clients, offering solutions to study-related challenges Coach and review the work of less experienced QA staff Collaborate with clients, regulatory bodies, and internal teams to ensure reporting accuracy and compliance Advise staff on GLP policies and best practices Maintain records and documentation supporting Quality Assurance activities Approach tasks flexibly, adapting to new and varied challenges Undergraduate degree (or equivalent experience) in agriculture, analytical chemistry, biology, food chemistry, or a related discipline Minimum of 2 years of relevant professional experience Strong knowledge of agricultural practices and analytical chemistry Excellent English skills (spoken and written); additional languages are an asset Strong communication skills, both verbal and written Exceptional attention to detail, organizational ability, and prioritization skills Ability to engage with clients mindfully and effectively, identifying additional client needs Experience working in multicultural teams within a global environment Commitment to delivering an outstanding customer experience in client project Work in a dynamic family-owned business environment with an international team where new ideas, creative approaches, and collaboration are valued. You will have the opportunity to work with market leaders in our industry. Development is at the core of our culture. At knoell, we offer opportunities to support your personal, leadership, and technical growth, including English language courses to help you communicate effectively in our business language. We value work-life balance and support part-time arrangements where business requirements allow. At knoell, you can participate in our global employee referral program and get rewarded for referring talent to the company. For our U.S.-based colleagues, knoell offers a competitive compensation and benefits package, including medical, dental, vision, life, and disability insurance, 401(k) with company match, and tuition reimbursement. We are an Equal Opportunity Employer and do not discriminate based on 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. knoell is a drug-free workplace. New hires may be required to pass a pre-employment drug test. knoell complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed during the application or interview process, please contact our Global Recruiting department. The above description is intended to reflect the general nature and level of work performed. It is not a comprehensive list of all duties, responsibilities, qualifications, or working conditions, and management reserves the right to revise it at any time. If you have any questions, feel free to reach out to us at **********************. If you're looking to join a global leader in regulatory and clinical services, where you can make a real impact and contribute to a team that values your contributions, then knoell is the place for you. We look forward to receiving your application!

Open Book Extracts Quality Assurance Specialist - Night Shift The Company Open Book Extracts is the complete source for hemp-derived cannabinoids, including wholesale raw ingredients, emulsions, custom formulations and EasySnaps. The Position We are seeking an experienced Quality Assurance Specialist - Night Shift who will be responsible for executing and expanding OBX's quality assurance program which includes: industry, regulatory, and cGMP manufacturing compliance and certification programs; in-house and third party product quality testing throughout the manufacturing process. The Quality Assurance Specialist - Night Shift must bring a high level of energy and possess a positive attitude and have the flexibility to adapt to the evolving regulatory landscape of the industry. Work schedule is Monday - Friday, 2:00pm-10:30pm; hours subject to change to meet business needs. This position will report to the Quality Manager and perform both Quality Assurance and Quality Control functions Responsibilities Performs in-process material checks of Production's intermediate products, finished ingredients, awaiting analytic testing. Completes sample preparation for the internal Quality Control Laboratory. Completes Quality Control line checks during EasySnap packaging operations. Reports material consumption, consumption of primary packaging materials, and any other requested Production/Quality information as requested by Management Complete production logs, quality control checks, and shift reports accurately and on time. Monitor machine performance and product quality, making real time adjustments to ensure efficiency, quality, and minimize downtime Troubleshoot basic mechanical or operational issues and escalate problems to maintenance or supervisors when needed. Assist production team with the completion of changeover forms, documenting machine adjustments, and set up/shut down procedures including set up of primary packaging, washing dishes, and general room cleanliness. Communicate effectively with teammates, supervisors, and other departments to ensure smooth shift transitions. Other duties as assigned by Management. Experience HS or equivalent required Solid understanding of Quality Assurance cGMP requirements for global regulatory filing Experience in FDA (food, dietary supplements, and pharmaceutical) environments preferred. Experience in the food, dietary supplement, or pharmaceutical industry over 1 year is preferred. High level of interpersonal skills, strong leadership abilities, organizational and time management skills. Excellent communicator. Ability to work independently and meet deadlines. Other Details This is a full-time position based out of Roxboro, NC Work schedule is Monday - Friday, 2:00pm-10:30pm; hours subject to change to meet business needs. Compensation commensurate with experience. Background and reference checks required. Physical Demands and Working Environment: Must be able to lift, carry and balance up to 50 pounds While performing the duties of this job, the employee is regularly required to perform grasping, talking, hearing, seeing and repetitive motions. Ability to walk and stand for long periods of time (5-6 hours) with frequent kneeling and bending. Working in limited climate-controlled facilities and may experience extreme heat or cold Work with heavy fumes, plants, airborne particles and chemicals Must be comfortable working with and around heavy machinery May experience moderately high noise levels Equal Employment Opportunity Statement Open Book Extracts is proud to be an equal opportunity employer. We embrace diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

**_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. **_Job Summary_** The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities. **_Responsibilities_** + Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers + Load and extract product systematic data on substances within Cardinal Health Master Data systems + Review and evaluate received questionnaire forms for completeness and applicability + Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks + Identify and quantify risk, communicate results effectively to management + Support management of QRA policies governing product quality data + Identify quality and regulatory related issues within current processes, investigate and provide recommendations + Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan. + Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health + Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk + Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains a broad knowledge of the technical disciplines in own functional area; applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise; influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes; in light of culture and diversity **_Qualifications_** + Bachelor's degree preferred + 1-3 years experience preferred + Knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP and California Proposition 65 preferred + Distribution Operations processes (Medical and Pharmaceutical) preferred + Excellent verbal, written, computer, SAP, and interpersonal skills required + Excellent influencing skills + Must be able to multitask and work with competing priorities **_What is expected of you and others at this level_** + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity implications **Anticipated hourly range:** $26.90 per hour - $36.90 per hour **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 12/07/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

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

Kincell Bio engineers cells into therapies . With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at ******************* Kincell is seeking a highly motivated Associate II who will be a key contributor to a dynamic and collaborative Quality Assurance team. Quality Assurance Associate II will primarily be responsible for supporting quality operation activities. This highly motivated member of the Quality Unit will promote a culture of compliance throughout the organization by reviewing all production-related documents and assisting with quality oversight of quality events. The Associate II oversees the generation and revision of product-related master documents to support GMP manufacturing of drug substances and drug products. Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance with applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to prioritize based on criticality effectively. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Actively participates in fostering a positive, collaborative work culture. Ensuring adherence to cGMPs across the organization. Addresses all quality and compliance matters in an open and timely manner. QA inspection and release of incoming controlled and critical material from the warehouse. Receipt, review, and process new item forms for material procurement in Veeva. Author and review standard operating procedures within the electronic document management system. Initiating Raw Material Specification form for critical received raw materials. Logbook creation, review, and archival. Document contingency management of on-the-floor documents and bimonthly maintenance of steady state documents. Document issuance and maintenance of routine forms for Manufacturing, Quality Control, and Microbiology. Maintain QA scanned documentation and document control room organization/archival Assist with reviewing preventive maintenance, calibration, and work order documentation in asset management software. Assist with approved vendor re-qualifications and manage the approved supplier list Assist in evaluating standard operating procedures, master batch records, and test methods for alignment with GMPs. Review executed records for accuracy, completeness, and adherence to internal standards and industry regulations. Observe and provide oversight to the manufacturing and laboratory areas, including aseptic processing areas. Gown aseptically for manufacturing suites and maintain qualification for aseptic gowning. Complete visual inspection of parenteral products. Maintain 20/20 (corrected) visual acuity. Will work directly with all departments and across sites to review and track executed documents to meet timelines. Provide status updates and reminders when necessary. Other duties as assigned. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. HS Diploma with 7+ years of relevant industry experience Bachelor's degree preferred in life sciences with 2+ Years of relevant industry experience Prefer experience with FDA Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) in the pharmaceutical, biologic, medical device, or human tissue industries in a Document Control position, including the revision, issuance, and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc. Microsoft Word and Microsoft Excel experience Exposure to 21 CFR Parts 210 & 211, 21 CFR 600, 21 CFR 820, and/or 21 CFR 1270, biotechnology, and electronic computer systems is desired Excellent communication skills, written and verbal. Team player with the ability to influence others. Detail-oriented, excellent written and verbal communication skills Effectively manages cross-functional communication Multitasks strategically and tactically in a fast-paced work environment. Strong organizational skills; able to prioritize and manage complex processes/projects. Ability to define problems, collect data, establish facts, and draw valid conclusions Ability to function in a rapidly changing environment and balance multiple priorities simultaneously. Physical Demands Adjusting or moving objects weighing up to 25lbs Travel Requirements N/A Location This is a site-based position located in Research Triangle Park, NC, and it will require some non-standard working hours, including early morning, late evening, and/or weekends. #LI-Onsite Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.

Count on Me - We know what to do, we make it easy, we do our part and we care! Job Title: FT/PT Quality Assurance Associate Success Factors Job Code: 1300594 Department: Center Store (Grocery) Reports To: Assistant Store Manager Where Applicable: Evening Manager Primary Purpose: Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice. Duties and Responsibilities: Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience Courteous and helpful to other associates Sweep and clean floors on nights with no scheduled vendor services Weekly cleaning of Produce, Market and Deli Departments Clean and organize the store mop room Find more efficient ways to do the job and seek to reduce costs and improve labor productivity Follow QA daily check list and sanitation standards set by Food Lion Follow current Standard Practices regarding cleanup of Hazardous Waste product Maintain a complete understanding of and adherence to company guidelines, policies and standard practice Understand and follow Food Safety and Workplace Safety guidelines and procedures Observe and correct all unsafe conditions that could cause associate or customer accidents Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty Ensure compliance with local, state and federal regulations Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses Perform all other duties as assigned Qualifications: High school graduate or equivalent preferred Excellent interpersonal, organizational, communication and customer service skills Ability and willingness to learn multiple tasks and technical requirements of the job Ability to use technical information to solve problems Must meet minimum age requirements to perform specific job functions Must be able to meet the physical requirements of the position, with or without reasonable accommodations Physical Requirements: Ability to use computers and other communication systems required to perform job functions Perform repetitive hand and arm motions Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion Pull or push up to 75 lbs. on occasion Stand 100% of the time, frequently walking short distances Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level Meet established volume activity standards for the position Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time Have sufficient visual ability to check ID cards, checks, invoices and other written documents 08/24/2021: Change in job code from 131/132 to SF job code 1300594

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

The Sr. Associate, Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. The Sr Associate, PQA position will facilitate real-time decision-making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. Responsibilities: Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support. Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Oversee and provide guidance during on-the-floor analytical testing. Ensure that changes that could potentially impact product quality are assessed according to procedures. Ensure that deviations from established procedures are investigated and documented per procedures. Alert senior management of quality, compliance, supply and safety risks. Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. Identification and implementation of continuous improvement opportunities within our processes and systems. Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Requirements / Qualifications: High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree Knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required. Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment?. Strong GMP and GDP Behaviors. Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with deviations. Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.

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

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.

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.

Job Description Open Book Extracts Quality Assurance Specialist - Night Shift The Company Open Book Extracts is the complete source for hemp-derived cannabinoids, including wholesale raw ingredients, emulsions, custom formulations and EasySnaps. The Position We are seeking an experienced Quality Assurance Specialist - Night Shift who will be responsible for executing and expanding OBX's quality assurance program which includes: industry, regulatory, and cGMP manufacturing compliance and certification programs; in-house and third party product quality testing throughout the manufacturing process. The Quality Assurance Specialist - Night Shift must bring a high level of energy and possess a positive attitude and have the flexibility to adapt to the evolving regulatory landscape of the industry. Work schedule is Monday - Friday, 2:00pm-10:30pm; hours subject to change to meet business needs. This position will report to the Quality Manager and perform both Quality Assurance and Quality Control functions Responsibilities Performs in-process material checks of Production's intermediate products, finished ingredients, awaiting analytic testing. Completes sample preparation for the internal Quality Control Laboratory. Completes Quality Control line checks during EasySnap packaging operations. Reports material consumption, consumption of primary packaging materials, and any other requested Production/Quality information as requested by Management Complete production logs, quality control checks, and shift reports accurately and on time. Monitor machine performance and product quality, making real time adjustments to ensure efficiency, quality, and minimize downtime Troubleshoot basic mechanical or operational issues and escalate problems to maintenance or supervisors when needed. Assist production team with the completion of changeover forms, documenting machine adjustments, and set up/shut down procedures including set up of primary packaging, washing dishes, and general room cleanliness. Communicate effectively with teammates, supervisors, and other departments to ensure smooth shift transitions. Other duties as assigned by Management. Experience HS or equivalent required Solid understanding of Quality Assurance cGMP requirements for global regulatory filing Experience in FDA (food, dietary supplements, and pharmaceutical) environments preferred. Experience in the food, dietary supplement, or pharmaceutical industry over 1 year is preferred. High level of interpersonal skills, strong leadership abilities, organizational and time management skills. Excellent communicator. Ability to work independently and meet deadlines. Other Details This is a full-time position based out of Roxboro, NC Work schedule is Monday - Friday, 2:00pm-10:30pm; hours subject to change to meet business needs. Compensation commensurate with experience. Background and reference checks required. Physical Demands and Working Environment: Must be able to lift, carry and balance up to 50 pounds While performing the duties of this job, the employee is regularly required to perform grasping, talking, hearing, seeing and repetitive motions. Ability to walk and stand for long periods of time (5-6 hours) with frequent kneeling and bending. Working in limited climate-controlled facilities and may experience extreme heat or cold Work with heavy fumes, plants, airborne particles and chemicals Must be comfortable working with and around heavy machinery May experience moderately high noise levels Equal Employment Opportunity Statement Open Book Extracts is proud to be an equal opportunity employer. We embrace diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

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

PT Quality Assurance Associate (Janitor/Custodian)

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