Quality Technician jobs at Quest Global

NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers. NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts. Work Shifts Time: 8a-4p Days: Mon-Fri Facility: CDU-WF facility on Rikers Island Duties & Responsibilities The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects. Responsibilities include: Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated. Identify patient and document all information pertinent to final report in the RIS and on images (PACS). Prepare all patients (infants, children, adolescents, adults and geriatric) for radiological procedures requested by the clinician. Arrange for proper protection of patients, public and staff from infectious diseases/materials. Perform all general diagnostic imaging and routine examination in CT and Angiography. Assists in performing daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories. Enters data and maintains documents and logs as required and mandated by the department QA guidelines and various regulatory agencies. Maintains adequate stocks of supplies and materials needed for use in the department. Checks equipment for defects prior for use and assures proper use of such equipment through instruction and review. Report any unexpected patient incidents in accordance with the occurrence report protocol. Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff. Perform other duties as deemed necessary (by supervisory or administrative staff) in the event of emergencies or disasters. Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities. Ensure all examinations are accessioned, documented and sent to PACS for reading. Monitor PACS and RIS incomplete worklists to ensure all exams are completed. In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality. Identifies activities that the network has implemented to promote patient safety and takes all necessary precautions to ensure a safe environment for patients, visitors and staff. In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following: Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures. Participates in quality assurance activities, including coordination, control and maintenance of technical equipment. Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability. Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers. Performs research and participates in special projects involving evaluation of equipment and delivery of service. Work with our radiologists to obtain updated documentation of primary diagnostic monitors. Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment. Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings. May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow. Minimum Qualifications Assignment Level III 1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity. 2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures. Department Preferences Possession of a current valid license as a General Radiological Technologist issued by the State of New York. A minimum of two years of experience as a Radiological Technologist. A current member of the American Registry of Radiologic Technologists (ARRT). Valid BLS required. Must possess a valid driver's license. Must be proficient in Microsoft Office Suite. Additional Salary Compensation All Radiologic Technologists in Assignment Levels II and III shall receive a differential of $7,500 per annum to be cross-trained on different modalities of radiologic imaging and to be cross-assigned (once trained) to different imaging settings depending on patient volume and staffing needs within a facility. Benefits NYC Health and Hospitals offers a competitive benefits package that includes: Comprehensive Health Benefits for employees hired to work 20+ hrs. per week Retirement Savings and Pension Plans Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts Loan Forgiveness Programs for eligible employees College tuition discounts and professional development opportunities College Savings Program Union Benefits for eligible titles Multiple employee discounts programs Commuter Benefits Programs

NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers, without exception, to live the healthiest life possible. Visit us at nychhc.org and stay connected on facebook.com/nyc HHC or Twitter@hhcnyc. NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts. Summary of position: The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects. Responsibilities include: Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated. Identify patient and document all information pertinent to final report in the RIS and on images (PACS). Prepare allpatients (infants, children,adolescents, adults andgeriatric) for radiological procedures requested bythe clinician. Arrange for proper protection of patients, public andstaff from infectious diseases/materials. Perform allgeneral diagnostic imaging and routine examination in CT and Angiography. Assists inperforming daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories. Enters data and maintains documents and logsas required andmandated by the department QAguidelines and various regulatory agencies. Maintains adequate stocks of supplies andmaterials needed foruse in thedepartment. Checks equipment for defects prior for useand assures proper use of such equipment through instruction and review. Report any unexpected patientincidents in accordance with theoccurrence report protocol. Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff. Perform other duties as deemed necessary (by supervisory oradministrative staff) inthe event of emergencies ordisasters. Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities. Ensure allexaminations are accessioned, documented and sentto PACS forreading. Monitor PACS and RIS incomplete worklists to ensure all exams arecompleted. In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality. Identifies activities thatthe network hasimplemented to promote patient safety andtakes all necessary precautions to ensure a safe environment for patients, visitors andstaff. In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following: Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures. Participates in quality assurance activities, including coordination, control and maintenance of technical equipment. Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability. Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers. Performs research and participates in special projects involving evaluation of equipment and delivery of service. Work with our radiologists to obtain updated documentation of primary diagnostic monitors. Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment. Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings. May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow. Department Preferences: Possession of a current valid license as a General Radiological Technologist issued by the State of New York. A minimum of two years of experience as a Radiological Technologist. A current member of the American Registry of Radiologic Technologists (ARRT). Valid BLS required. Must possess a valid driver's license. Must be proficient in Microsoft Office Suite. Minimum Qualifications: Assignment Level III 1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity. 2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures.

The incumbent will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. The employee will support operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support manufacturing record and logbook reviews and track them through their post-execution life cycle. The individual will monitor GDP execution and provide feedback, coaching, and training to ensure ‘Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle. This person will also ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department. The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. They will initiate and complete deviations, capas, and change controls, as needed, to support operations. Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned. Position Responsibilities Release electronic manufacturing records and logbooks. Perform reviews of electronic logbooks and manufacturing records. Prepare and track departmental manufacturing records and logbooks throughout entire lifecycle and support executed record reviews and comment resolution Author, train, review manufacturing procedures Oversee and execute against departmental compliance activities associated with QA Systems such as deviations, CAPAs, and change controls Develop and oversee manufacturing training plan, and training compliance for department. Other duties as assigned Position Requirements Bachelor's degree in a related scientific or engineering discipline preferred and 2-4 years' experience for specialist in related GMP manufacturing operations or QA; or 4-6 years' experience with a high school degree, or equivalent. Demonstrated knowledge of cell culture or fermentation unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Strong attention to detail, as well as, presentation, written, and verbal communication skills required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Experience working with electronic QA Systems such as documentation, deviations, capas, and change control systems is preferred. Salary: Manufacturing Specialist I: $55,000-$70,000 Manufacturing Specialist II: $65,000-$80,000 Manufacturing Specialist III: $75,000-$100,000 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.

The incumbent will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. The employee will support operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support manufacturing record and logbook reviews and track them through their post-execution life cycle. The individual will monitor GDP execution and provide feedback, coaching, and training to ensure 'Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle. This person will also ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department. The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. They will initiate and complete deviations, capas, and change controls, as needed, to support operations. Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned. Position Responsibilities * Release electronic manufacturing records and logbooks. Perform reviews of electronic logbooks and manufacturing records. Prepare and track departmental manufacturing records and logbooks throughout entire lifecycle and support executed record reviews and comment resolution * Author, train, review manufacturing procedures * Oversee and execute against departmental compliance activities associated with QA Systems such as deviations, CAPAs, and change controls * Develop and oversee manufacturing training plan, and training compliance for department. * Other duties as assigned Position Requirements * Bachelor's degree in a related scientific or engineering discipline preferred and 2-4 years' experience for specialist in related GMP manufacturing operations or QA; or 4-6 years' experience with a high school degree, or equivalent. * Demonstrated knowledge of cell culture or fermentation unit operation is preferred. Experience in single-use platform technology is preferred. * Excellent written and verbal communication skills are required. * Strong attention to detail, as well as, presentation, written, and verbal communication skills required. * Energetic, motivated and dynamic individual. * Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. * Experience working with electronic QA Systems such as documentation, deviations, capas, and change control systems is preferred. Salary: Manufacturing Specialist I: $55,000-$70,000 Manufacturing Specialist II: $65,000-$80,000 Manufacturing Specialist III: $75,000-$100,000 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.

Are you passionate about being part of a Team that will become the most trusted medical device machining service provider? Are you tired of mundane cubicle roles? Join Team Orchard Park as a Quality Technician, state-of-the-art, inspection equipment and realize your full potential as a High Impact member of our Quality team. New employees are eligible for the following benefits effective date of hire! Medical, dental, and vision benefits Company-paid life insurance Generous Paid time off and 10 paid Holidays 401k Plan with Company Match Tuition Reimbursement Attendance Bonus paid monthly GROWTH: This is an outstanding opportunity for a Quality Technician/CMM Programmer that has an attention to detail, thrives in cross-functional teams, and is ready for the next big challenge. You will be working in a highly dynamic work environment that encourages and promotes developmental growth in many areas. MISSION: We collaborate and innovate with our customers to provide the highest quality, life enhancing medical devices in the world. Key Responsibilities: Program, operate and troubleshoot automated inspection equipment, including CMM, Smart Scopes, and VICI systems, to ensure accurate product measurements. Interpret blueprints and technical drawings using GD&T principles. Conduct First Article Inspections. Utilize manual measurement tools (e.g., micrometers, pin gages, ring gages) Conduct root cause investigations for non-conforming equipment or parts. Write, improve, and submit work instructions for review and release to ensure standardized processes. Education, Experience, and Skills: High school diploma 2 - 5 years of experience programming and operating automated inspection equipment (e.g., CMM, Smart Scopes, VICI). Ability to read and assess product drawings Demonstrate understanding of basic Quality System Regulations Working knowledge of Excel and database programs Basic understand of automated systems and programming We offer market competitive compensation. Potential salary range for this role is $25.00-$30.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. CLICK HERE FOR A SITE TOUR! All job offers are contingent on passing a background check and drug test (including THC)

Manufacturing Technician Chesapeake, VA Full Time, $17.50 Job Overview: The Manufacturing Technician plays a crucial role in ensuring the safe and efficient operation of the production process. This position is responsible for monitoring and maintaining equipment, supporting inventory management, and assisting with troubleshooting and quality control. The role requires teamwork, attention to detail, and an ability to adapt to changing production needs. Key Responsibilities: Adhere to the “Safety First” philosophy, actively participate in safety programs, and ensure compliance with all safety standards. Track and assemble granulation production data, monitor Fluff Silo levels, and assist with material flow. Execute daily granulation and housekeeping plans, keeping the team updated on equipment and material status. Perform Bulk Density quality checks to maintain product uniformity and respond to any quality issues with the correct process adjustments. Accurately document all production activities, including quality checks, process conditions, and maintenance activities. Ensure compliance with appropriate forms and logbooks. Promote team collaboration, effectively communicate across shifts, and support new team members through training and mentorship. Assist with troubleshooting and continuous improvement initiatives. Qualifications: Strong interpersonal and communication skills, with a focus on teamwork and collaboration. High level of self-motivation, integrity, and professionalism. Ability to work overtime, rotating shifts, weekends, and holidays as needed. Willingness to learn and grow within various plant operations and functions. Experience with forklifts and material handling equipment is preferred. Proactive approach to maintaining a clean and organized work environment. Additional Information: This position requires the ability to troubleshoot equipment, support maintenance efforts, and assist in cross-functional operations as needed. Must be flexible, with a strong commitment to team success and continuous improvement.

Additive Manufacturing Technicians will be responsible for the operation of 3D LBPF metal printers, including CAD model review, build preparation. Tuesday - Saturday, 8:00 am - 4:30 pm Sunday - Thursday, 8:00 am - 4:30 pm PRINCIPAL RESPONSIBLITIES Principal responsibilities for the position include the following. Other duties may be assigned as necessary. Full operation of 3d metal printers. Includes machine unload, setup, operation, maintenance and general upkeep and troubleshooting. CAD model review, build preparation and general software support for metal printers. Reviewing model drawings and processing requirements and creating device records. Aid in post-processing steps done on common shop equipment (micro-blasting, grinding wheel, deburring tools). Aid in testing of verification samples on hydraulic and electronic test frames. Support R&D engineers during testing of devices for other purposes. Follow all appropriate safety precautions, including usage of PPE and maintaining lab cleanliness. Visual inspection of manufactured goods as part of quality-controlled process. EDUCATION High school diploma or GED Some college education is preferred. Preference given to technical training and degree work. EXPERIENCE Strong attention to detail Ability to work in a regulated industry, including adherence to proper paperwork protocols and good quality practices. Ability to routinely lift 35 lbs during a shift Ability to be standing for 3+ hours during a shift Strong visualization skills TOOLS AND EQUIPMENT Position may involve the use of: Basic hand tools Direct Metal Printers Polymeric 3D Printers Media Blasting Cabinet Testing Frames Cleaning and Inspection Equipment Respirator and fire-retardant PPE MATERIALS HANDLING / EXPOSURE Position will involve handling of ultra-fine, medical grade, metallic powder. May involve handling of other raw materials and waste material applicable to the manufacture of medical devices. SUPERVISORY RESPONSIBILITIES Position does not have supervisory responsibilities. PHYSICAL ACTIVITIES Position requires the ability to intermittently lift and carry up to 35 pounds and to operate while wearing a full-face respirator, protective clothing, eye protection, and/or hearing protection. A respirator fit test will be required prior to working with a respirator. Position may require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder. WORKING CONDITIONS Working conditions include standard office and laboratory conditions as well as conditions of a machine shop. Machine shop conditions may include noise, dust, and elevated temperatures. restor3d is an equal opportunity employer

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, Mirror Polishing, media blasting, filing, cleaning, and packaging. Essential Duties and Responsibilities: Duties and responsibilities Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP) Support equipment maintenance activities as needed Participate in continuous improvement projects Perform inspections for components and product at all stages of manufacturing process Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820. Qualifications and Experience: High school diploma or GED required Associates or post-secondary education preferred Experience in the use Rotary tools, Die Grinders, is required Experience in the use of basic machine shop tools and equipment is required Mechanically inclined Working knowledge of GMP, GLP, and GDP is required Strong verbal and written communication Experience in FDA 21 CFR 820 Quality system is preferred Tools and Equipment Position may involve the use of: Basic hand tools Rotary tools Media blasting cabinet Cleaning and inspection equipment Sealing and packaging equipment Respirator, protective clothing, eye protection, and hearing protection Position may involve handling of or exposure to metallic powders and other powered materials, mill coolant, tapping fluid, polymeric resins, cleaning solutions, inert gases, and acids. Physical Activities Skills, Abilities, Competencies Required: Position requires the ability to intermittently lift and carry up to 50 pounds PPE including eye protection, hearing protection, and gowning required depending on task performed May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes. Working conditions may also include working in a clean room environment. Clean room environment will require wearing PPE - Gown, hair net, shoe covers and nitrile gloves. restor3d is an equal opportunity employer

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, media blasting, polishing, filing, cleaning, and packaging. Essential Duties and Responsibilities: Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP) Support equipment maintenance activities as needed Participate in continuous improvement projects Perform inspections for components and product at all stages of manufacturing process Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820. Qualifications: High school diploma or GED required Associates or post-secondary education preferred Experience in the use of basic machine shop tools and equipment is required Mechanically inclined Working knowledge of GMP, GLP, and GDP is required Strong verbal and written communication Experience in FDA 21 CFR 820 Quality system is preferred TOOLS AND EQUIPMENT Basic hand tools Rotary tools Polymeric 3D printers Media blasting cabinet Furnace or ovens Materials testing frames Cleaning and inspection equipment Sealing and packaging equipment Respirator, protective clothing, eye protection, and hearing protection MATERIALS HANDLING / EXPOSURE Position may involve handling of or exposure to metallic powders and other powder materials, polymeric resins, cleaning solutions, inert gases, and acids. Skills, Abilities, Competencies Required: Position requires the ability to intermittently lift and carry up to 50 pounds PPE including eye protection, hearing protection, and gowning required depending on task performed May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes. Work environment may also include a controlled environment requiring the technician don PPE such as gown, hair net, shoe covers and nitrile gloves. restor3d is an equal opportunity employer

The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon's products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager. Perform line clearance activities and in-process inspections. Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below) Transfer materials between facilities (see lifting requirements below) Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215 Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232 Operate testing equipment such as force testers, torque testers, and balances. Report all deviations in product, components, raw materials, and equipment per their relevant procedures Perform document control activities, including but not limited to printing logbooks and batch records. Transcribe data into digital systems for tracking Quality Metrics. Batch record review & support routine batch disposition Requirements Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred) Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred) Ability to be Gowning Qualified per Cresilon's SOP. 1 year experience in regulated industry highly desirable Ability to lift, walk, stand, reach, pull and push Benefits · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement The salary for this role is $25/Hour Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon's products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager. Perform line clearance activities and in-process inspections. Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below) Transfer materials between facilities (see lifting requirements below) Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215 Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232 Operate testing equipment such as force testers, torque testers, and balances. Report all deviations in product, components, raw materials, and equipment per their relevant procedures Perform document control activities, including but not limited to printing logbooks and batch records. Transcribe data into digital systems for tracking Quality Metrics. Batch record review & support routine batch disposition Requirements Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred) Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred) Ability to be Gowning Qualified per Cresilon's SOP. 1 year experience in regulated industry highly desirable Ability to lift, walk, stand, reach, pull and push Benefits · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement The salary for this role is $25/Hour Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role at Baxter This is where my hands make life-sustaining products You are driven by the knowledge that the products you help make saves and sustain lives. You can move quickly, address questions, and encourage teammates, all while getting quality products out on time. You are calm, positive, and a key part of a fast-paced environment that emphasizes camaraderie and teamwork. As a Production Technician I, Fill/Pouch, you are happiest when you are moving, and we will not disappoint! Baxter is known for its speed and high-quality product. Our manufacturing operations are around-the-clock to meet the needs of our customers. Our high-caliber talent works through the challenges at hand while pushing toward meeting client order needs. Different shift assignments allow for flexibility and safety. Your team Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. You'll be offered extensive training, and the tight-knit working environment within the Manufacturing team means employees get additional training from their direct manager and peers when needed. What we offer from Day One: Shift flexibility to trade shifts and leverage overtime opportunities Medical, Dental and Vision coverage 160 hours of Paid Time Off and Paid Holidays 401K match Employee Stock Purchase Program Paid Parental Leave Tuition Reimbursement What You'll Be Doing The Fill/Pouch Production Technician I is a Salaried Non-Exempt position which contributes to our mission of saving and sustaining lives by supplying, operating, and maintaining various equipment in the Fill areas. Additional tasks will include the performance and documentation of all quality checks for responsible equipment as well as inspection of product at all times. Operate, monitor and make adjustments as necessary to manual and automated filling equipment and machines using controls on an electrical control panel (HMI) or by way of manual adjustments. Set-up load and replenish production supplies by use of a powered industrial truck (PIT) at a rate consistent with production needs. Perform minor routine and preventative maintenance such as alignment adjustments, replacement of machine parts or belts, cleaning and lubrication while supporting Total Productive Maintenance (TPM). Reconcile headcount needed on a per shift basis based on schedule production demands. Perform scheduled quality checks, disposition product, identify any deviations that may occur and take the appropriate action to include stopping production on the machine if necessary. Inspect finished product to ensure quality standards are being met. Complete batch/code changes, tank changes, as well as sub lots as needed. Document required information on manufacturing logs and/or POMS system. Investigate, identify and correct or escalate any inefficiency in the machine's performance including mechanical wear, alignment, adjustment, and setup issues. Develop standard work for troubleshooting and setups/changeovers. Read blueprints and use tools to measure the product, ensuring the output meets specifications, making adjustments/repairs as needed. Perform and document scheduled cleaning activities. Assist in Quality Improvement or VIP programs if required. Work with Supervisor and Assistant Supervisor to coordinate training requirements for line staff. Train new associates on responsible processes. Ensure the proper use, care, and storage of tools and equipment. Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur. Learn, understand and apply meticulous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Sustain a clean and safe work area using 6S principles including maintaining and securing provided tools. What You'll Bring High School Diploma or GED and must be at least 18 years of age. CRC (Career Readiness Certification) at the Silver level preferred. Production Technician or manufacturing experience with duties including preventative maintenance, machine troubleshooting, etc. preferred. Basic English written and oral communication skills adequate to communicate with other team members. Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings. Ability to perform basic mathematics. Proficient in how to use a calculator and measurement tools as well as basic hand tools. Basic computer skills. Physical Requirements This position requires frequent grasping, pushing/pulling and reaching with hands and arms. The position also involves lifting up to 50 pounds occasionally throughout the shift. Pass the Powered Industrial Truck (P.I.T.) physical. Normal visual acuity and the ability to distinguish color are necessary. Occasionally specialized physicals are required when working with certain drug codes. Ability to bend/stoop, squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a pay rate of $44,000.00 annually. Applicants must be authorized to work for any employer in the U.S. We are un-able to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

The incumbent will oversee tech transfer activities for Upstream or Downstream Manufacturing and serve as the technical leader for the department. The Specialists' Manager will oversee the Upstream or Downstream Manufacturing specialist team to ensure that Manufacturing tech transfer responsibilities are met to ensure ‘On-Time” and “Right the First time' execution of production activities. The individual will oversee manufacturing record generation, equipment enrollment, operation, and maintenance, manufacturing projects and studies, and drive operational excellence initiatives for the department. The Specialists' Manager will oversee Manufacturing Specialists and will report to the Director of Manufacturing Technical Operations. The individual will be responsible for managing mid-term and long-term manufacturing readiness planning and be the primary point of contact for daily issue escalation with respect to tech transfer and readiness tasks. The individual will ensure their team maintains strict accordance with SOPs and Good Manufacturing Practices. The individual will also be responsible for ensuring their staff work cross-functionally to ensure operations are both reliable and successful. This requires a drive for continuous improvement and simplicity and looking for opportunities to ensure equipment operation is reliable. This proven and qualified candidate will use their past experiences, depth and knowledge of fundamentals in media/buffer preparation, seed expansion, bioreactor operations, cell culture harvest operations, chromatography, ultrafiltration/nanofiltration and drug substance filling operations to teach, troubleshoot and continuously improve the production operations of Manufacturing. The ideal candidate will be both technically sound as well as an experienced team motivator and coach. The Specialists' Manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment and troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed. Job Responsibilities Oversee manufacturing tech transfer activities including: Manufacturing record generation, MRP BOM and work order generation, and enrollment of materials and equipment Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed Ensure equipment and Manufacturing facilities remain in working order by overseeing manufacturing specialists and ensuring vendor repairs as needed, maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Job Requirements Bachelor's degree in a related scientific or engineering discipline and 10+ years' experience in related GMP manufacturing operations; 6+ years prior leadership/supervisory experience. Demonstrated knowledge of cell culture, fermentation, or purification unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. 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 KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility. This role will support, but not limited to the following: Drafting, routing, and revision of manufacturing batch records, procedures, supporting records. Manufacturing process support during on-going shop floor execution, when required. Support new equipment enrollment efforts from purchasing to qualification activities. First line of defense for manufacturing events. The candidate will assess the event and provide immediate corrective actions. Lead implementations for corrective and preventive actions. Point of contact for laboratory equipment supporting manufacturing operations, troubleshooting, vendor calls, equipment repair coordination, operational changes and system qualifications. Support safety initiatives, compliance & quality requirements. Job Responsibilities: Generation of batch records, solution records, equipment preparation records, processing assembly records, test sampling plans and process flow charts for specific manufacturing process units. Manufacturing laboratory equipment: work order initiation and follow up, assessments to support deviations, troubleshooting and vendor coordination. CAPA and Change Control implementations, Safety Improvement implementations. Manufacturing operation executions. Support activities associated with Operational Excellence Initiatives including Error Proofing, Standardization, 5S, Lean Manufacturing Job Requirements: Knowledge, Skills, Abilities: Specialist I: High School Diploma with 5+ years' related industry experience (fermentation, cell culture, purification); Bachelor's Degree in a related scientific or engineering discipline preferred with 2+ years' related industry experience; Master's degree in a related scientific or engineering discipline preferred with 0+ year's related industry experience. Specialist II: High School Diploma with 8+ years' related industry experience (fermentation, cell culture, purification); Bachelor's Degree in a related scientific or engineering discipline preferred with 4+ years' related industry experience; Master's degree in a related scientific or engineering discipline preferred with 2+ year's related industry experience. Language Ability: Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine GMP documents. Ability to speak effectively on front of internal groups. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Computer Skills: Knowledge of and experience using MS Office Software, Electronic Document Management Systems, Email Equipment Use: Knowledge of and experience using equipment - (Examples include Office Equipment, Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography columns/skids, Ultrafiltration systems, drug substance filling operations, Peristaltic Pumps and Other Single Use pumps, Automated Cell, Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, and other lab and production equipment) KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. " Position will be based out of our brand new plasma donation facility in the Rochester, NY opening October 2025! BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Performs duties associated with Quality (including but not limited to): (50%) Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR). Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation. In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations. Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%) Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%) Maintain certification and perform all required duties of Lead Technician. (10%) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience. Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician). Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment. Effective communication, organizational, and technical/problem-solving skills. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Ability to multi-task and work as a team player. Innovation Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs. Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required Desired: Associate or Bachelor's degree preferred ADDITIONAL INFORMATION FLSA Classification (US) - Non-Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NY - Rochester U.S. Hourly Wage Range: $21.00 - $28.88 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NY - Rochester Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No

fairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and dairy products to nourish consumers. With over $3B in annual retail sales, fairlife's portfolio of delicious, lactose-free, real dairy products includes: fairlife ultra-filtered milk; Core Power High Protein Shakes, a sports nutrition drink to support post-workout recovery; fairlife nutrition plan™, a nutrition shake to support the journey to better health. A wholly owned subsidiary of The Coca-Cola company, fairlife, LLC has been recognized by both Fast Company and Nielsen for its industry leading innovation. To learn more about fairlife and its complete line of products, please visit fairlife.com. The construction of fairlife's manufacturing facility in Webster, NY is underway. This state-of-the-art, 750k sq ft, greenfield plant is expected to be operational in late 2025 and will lay the foundation for fairlife's next phase of growth as the leading dairy nutrition provider. While coupling the industry's latest technologies and fairlife's operational excellence to build this world-class facility, fairlife plans to hire 250 new employees and bring in approximately 5 million lbs. of milk a day, with room to grow over the coming years. shift schedule: 12 Hour Nights: This is a night shift position , with hours from 6:00 PM to 6:00 AM. The role follows a rotating 2-2-3 schedule: two days on, two days off, three days on, followed by two days off, two days on, and three days off. Team members will work every other weekend, including Friday, Saturday, and Sunday. Shift Differential of $2 per hour for night shift. job purpose: Entry level position that provides key support for the Quality Department including: water testing, raw milk testing, raw and pasteurized load out testing, Finished Product testing, microbiological testing, chemical titrations, and work-in-process testing. Employee is responsible for generating daily reports, data entry and collection, project assistance, filing, assist in conduct of special studies, calibrations, data collection, and communicating with other departments. responsibilities: Ability to operate lab testing instrumentation correctly. Testing includes moisture/solids, protein, fat and pH. Technicians will be responsible for understanding microbiological plating, Foss analytical equipment, pH meter and other laboratory instrumentation as needed. All instrumentation is to be operated in a safe, efficient, and sanitary manner. May be required to obtain and maintain a NYS milk receiver, Appendix N and or Phosphatase License. Ensures raw milk is received within specifications and meets all food safety and quality requirements Perform testing and documenting of bulk product loadouts. Perform daily quality line audits, evaluations and testing on plant floor as assigned. May be required to perform sensory evaluations on all finished products. Fill out required laboratory data worksheets and logs in an accurate manner. Maintain all results and reports in a confidential manner in accordance with the Company Letter of Confidentiality. Responsible for maintaining a clean, orderly, and neat work area at all times. Must keep area stocked with sufficient supplies to perform job responsibilities. Computer skills including Microsoft Word and Excel. Communication of results to the proper individuals in a timely, confidential, and professional manner. Preparation of all solutions and media required in the performance of laboratory tests. Recognize and notify Quality Assurance Manager and appropriate operations supervisors of any unusual results or product defects. Perform the necessary re-checks for analytical and microbiological test. Report immediately to supervisor or manager of any damage, irregular activity, or unsafe conditions concerning the plant equipment or lab instrumentation. Follow all safety, work, and Good Manufacturing Practices (GMP) and GLP's rules. Ensure verification of approved incoming raw milk producers. May be required to be PMO certified for raw milk sampling and antibiotic residue screening. Assists with state and federal screening inspections. Perform other duties as assigned by management. skills/qualifications required: College is highly preferred but not required. Minimum of (1) year experience in a laboratory setting is required. Proficiency in English: Comfortable with both written and verbal communication, including reading and writing. working conditions and physical requirements: 40-45 hours/sitting/standing/walking/lifting. Ability to lift up to 50 lbs. Assist can be provided food safety requirements: Notify supervision of any repairs or adjustments that are required that may affect product quality or food safety. Understand, observe, and comply with the handling and usage of the color-coded container policy while in the Production Areas. Perform all duties necessary to meet Company, Customer and/or Government requirements/standards as prioritized by the Company. Ability to initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system. Identify and record any problems relating to Food Safety and the Quality of the ingredients, processes, quality system, or safety system. Control further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected. In the event of absence, another employee with the same skill level will assume the duties and responsibilities as required. position location: Webster, NY reports to: Quality Supervisor travel requirements: None exempt/nonexempt: nonexempt This position is eligible for bonus. *Base pay offered may vary depending on geography, job-related knowledge, skills, and experience. A full range of medical, financial, and/or other benefits, dependent on the position, is offered. Base pay range:$25.50-$29.50 USD fairlife, LLC is an equal opportunity employer. We do not discriminate on the basis of 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. All qualified applicants and employees will be given equal opportunity. Selection decisions are based on job-related factors. In addition to its nondiscrimination commitment, the Company will also provide reasonable accommodation of qualified individuals with known disabilities unless doing so would impose an undue hardship on the Company. If you have a disability and would like to request accommodation in order to apply for a position with us, please email ******************** . For Recruitment Agencies At fairlife, we manage the majority of our hiring internally through our dedicated Talent Acquisition team, which is actively engaged in direct candidate sourcing. Most of our roles are filled through applications submitted via our careers site or through direct outreach by our team. As our recruitment is primarily handled in-house, we work only occasionally with external agencies, and only those on our existing, pre-approved vendor list. At this time, we are not reviewing or expanding that list. Unsolicited resumes or submissions from external agencies not authorized by our Talent Acquisition team will be considered direct candidate applications. As such, fairlife will not assume responsibility for any placement fees associated with these submissions.

Job Description fairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and dairy products to nourish consumers. With over $3B in annual retail sales, fairlife's portfolio of delicious, lactose-free, real dairy products includes: fairlife ultra-filtered milk; Core Power High Protein Shakes, a sports nutrition drink to support post-workout recovery; fairlife nutrition plan™, a nutrition shake to support the journey to better health. A wholly owned subsidiary of The Coca-Cola company, fairlife, LLC has been recognized by both Fast Company and Nielsen for its industry leading innovation. To learn more about fairlife and its complete line of products, please visit fairlife.com. The construction of fairlife's manufacturing facility in Webster, NY is underway. This state-of-the-art, 750k sq ft, greenfield plant is expected to be operational in late 2025 and will lay the foundation for fairlife's next phase of growth as the leading dairy nutrition provider. While coupling the industry's latest technologies and fairlife's operational excellence to build this world-class facility, fairlife plans to hire 250 new employees and bring in approximately 5 million lbs. of milk a day, with room to grow over the coming years. shift schedule: 12 Hour Nights: This is a night shift position , with hours from 6:00 PM to 6:00 AM. The role follows a rotating 2-2-3 schedule: two days on, two days off, three days on, followed by two days off, two days on, and three days off. Team members will work every other weekend, including Friday, Saturday, and Sunday. Shift Differential of $2 per hour for night shift. job purpose: Entry level position that provides key support for the Quality Department including: water testing, raw milk testing, raw and pasteurized load out testing, Finished Product testing, microbiological testing, chemical titrations, and work-in-process testing. Employee is responsible for generating daily reports, data entry and collection, project assistance, filing, assist in conduct of special studies, calibrations, data collection, and communicating with other departments. responsibilities: Ability to operate lab testing instrumentation correctly. Testing includes moisture/solids, protein, fat and pH. Technicians will be responsible for understanding microbiological plating, Foss analytical equipment, pH meter and other laboratory instrumentation as needed. All instrumentation is to be operated in a safe, efficient, and sanitary manner. May be required to obtain and maintain a NYS milk receiver, Appendix N and or Phosphatase License. Ensures raw milk is received within specifications and meets all food safety and quality requirements Perform testing and documenting of bulk product loadouts. Perform daily quality line audits, evaluations and testing on plant floor as assigned. May be required to perform sensory evaluations on all finished products. Fill out required laboratory data worksheets and logs in an accurate manner. Maintain all results and reports in a confidential manner in accordance with the Company Letter of Confidentiality. Responsible for maintaining a clean, orderly, and neat work area at all times. Must keep area stocked with sufficient supplies to perform job responsibilities. Computer skills including Microsoft Word and Excel. Communication of results to the proper individuals in a timely, confidential, and professional manner. Preparation of all solutions and media required in the performance of laboratory tests. Recognize and notify Quality Assurance Manager and appropriate operations supervisors of any unusual results or product defects. Perform the necessary re-checks for analytical and microbiological test. Report immediately to supervisor or manager of any damage, irregular activity, or unsafe conditions concerning the plant equipment or lab instrumentation. Follow all safety, work, and Good Manufacturing Practices (GMP) and GLP's rules. Ensure verification of approved incoming raw milk producers. May be required to be PMO certified for raw milk sampling and antibiotic residue screening. Assists with state and federal screening inspections. Perform other duties as assigned by management. skills/qualifications required: College is highly preferred but not required. Minimum of (1) year experience in a laboratory setting is required. Proficiency in English: Comfortable with both written and verbal communication, including reading and writing. working conditions and physical requirements: 40-45 hours/sitting/standing/walking/lifting. Ability to lift up to 50 lbs. Assist can be provided food safety requirements: Notify supervision of any repairs or adjustments that are required that may affect product quality or food safety. Understand, observe, and comply with the handling and usage of the color-coded container policy while in the Production Areas. Perform all duties necessary to meet Company, Customer and/or Government requirements/standards as prioritized by the Company. Ability to initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system. Identify and record any problems relating to Food Safety and the Quality of the ingredients, processes, quality system, or safety system. Control further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected. In the event of absence, another employee with the same skill level will assume the duties and responsibilities as required. position location: Webster, NY reports to: Quality Supervisor travel requirements: None exempt/nonexempt: nonexempt This position is eligible for bonus. *Base pay offered may vary depending on geography, job-related knowledge, skills, and experience. A full range of medical, financial, and/or other benefits, dependent on the position, is offered. Base pay range:$25.50-$29.50 USD fairlife, LLC is an equal opportunity employer. We do not discriminate on the basis of 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. All qualified applicants and employees will be given equal opportunity. Selection decisions are based on job-related factors. In addition to its nondiscrimination commitment, the Company will also provide reasonable accommodation of qualified individuals with known disabilities unless doing so would impose an undue hardship on the Company. If you have a disability and would like to request accommodation in order to apply for a position with us, please email ******************** . For Recruitment Agencies At fairlife, we manage the majority of our hiring internally through our dedicated Talent Acquisition team, which is actively engaged in direct candidate sourcing. Most of our roles are filled through applications submitted via our careers site or through direct outreach by our team. As our recruitment is primarily handled in-house, we work only occasionally with external agencies, and only those on our existing, pre-approved vendor list. At this time, we are not reviewing or expanding that list. Unsolicited resumes or submissions from external agencies not authorized by our Talent Acquisition team will be considered direct candidate applications. As such, fairlife will not assume responsibility for any placement fees associated with these submissions.

The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon's products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: * Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager. * Perform line clearance activities and in-process inspections. * Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below) * Transfer materials between facilities (see lifting requirements below) * Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215 * Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232 * Operate testing equipment such as force testers, torque testers, and balances. * Report all deviations in product, components, raw materials, and equipment per their relevant procedures * Perform document control activities, including but not limited to printing logbooks and batch records. * Transcribe data into digital systems for tracking Quality Metrics. * Batch record review & support routine batch disposition