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

Posted 30+ days ago

QA Tech II-Concrete NACE or AMPP Certified-logo
QA Tech II-Concrete NACE or AMPP Certified
Thompson Pipe GroupGrand Prairie, Texas
Description Position at TPG Pressure Inc QA Tech II Description: Who We Are Thompson Pipe Group is a privately held family business of engineers, contractors, and manufacturers based in Rialto, California. From the humble beginnings, we built a family of products to meet the needs of all kinds of infrastructure. Each generation of products is better than the previous. Thompson Pipe Group is now the largest and most diverse drainage, sanitary, pressure and trench-less pipe provider, with manufacturing locations across the country and serving not just the US but all North America. Please visit our website at www.thompsonpipegroup.com Thompson Pipe Group is currently looking for a Quality Technician. Hourly rate of $25.00 to $35.00 based on experience. Hours:6AM - 4:30PM Overtime Required / may work some saturdays . The Quality Assurance Technician will work within the Quality department and alongside Production Operations to ensure the highest level of quality for Thompson Pipe Group – Pressure products. The position will collaborate with various departments within the facility to ensure knowledge of, and compliance with, project-specific quality assurance requirements. Responsibilities Working as part of dynamic team, Audit and Inspect raw materials, in process, and final product to ensure compliance with applicable project requirements Perform Visual Coating Inspections Perform or Witness Testing of Various Coatings Maintain records of all quality, test, and inspection reports, including: Concrete and Mortar Strength reports Under the supervision of the QA Supervisor , monitor all aspects of product Quality Identify, document, and report all non-conforming conditions Sample, Test, Report, and Evaluate tests conducted on Cement Mortar Coating Sample, Test, Report, and Evaluate tests conducted on Steel Tensile Strength Sample, Test, Report, and Evaluate tests conducted on Small and Large Aggregates Identify, Support, Report and Evaluate Joint Assembly Test reports Audit, Review and Validate production reports Review material certifications/test reports on component materials to assure compliance with project requirements Assist Production personnel who have been assigned quality control responsibilities. Ensure compliance with any additional or special quality assurance procedures required by project specifications Perform other duties as assigned Requirements Current NACE Level 2 or NACE Level 3 / AMPP Certified Coating Inspector or Senior Certified Coating Inspector Plus but not required: Current “American Welding Society” Certified Welding Inspector, “AWS”-CAWI, or CWI, or SCWI Non-Destructive testing, Current or Previous ASNT-TC-1A certification to Level 1, 2, or 3. Certification in one or more of the following disciplines: PT, MT, UT. Desired Qualifications Knowledge of concrete technology, ACI certification is a plus. Prior training in Welding and Nondestructive Evaluation/Testing (NDE/NDT). High school diploma or general education degree (GED). Previous experience in a Manufacturing setting, Quality Assurance or Production. Proficient in the Microsoft Office suite of applications. Bilingual in English and Spanish. What We Offer Top-tier Medical, Dental, and Vision Benefits Life and Supplement Life Company Matched 401K Retirement Plan Paid Holidays Fun Events Training and Development Employee Discounts Career Opportunity! We are located at 1004 MacArthur Blvd. Grand Prairie, TX 75050 Question about the Position? You can contact us at 469-313-2469 EOE/AA – M/F/Vet/Disability Thompson Pipe Group – Pressure is an Equal Opportunity Employer

Posted 1 day ago

RN QA homecare and or hospice must have experience-logo
RN QA homecare and or hospice must have experience
University Home CareLivonia, Michigan
University Home Care is looking for a skilled Registered Nurse with Quality Assurance experience in the homecare and/or hospice setting to join our team in Livonia, MI. Conduct quality assurance checks on patient care plans and documentation. Ensure compliance with all regulatory requirements. Develop and implement quality improvement initiatives. Provide training to staff on quality assurance measures. Active RN license in the state of Michigan. Prior experience in Quality Assurance in homecare and/or hospice. Strong knowledge of regulatory requirements in homecare/hospice. Excellent communication and organizational skills. Competitive salary. Health and dental insurance. Paid time off. 401(k) retirement plan. University Home Care is a leading provider of homecare services in the Livonia, MI area. We are committed to providing high-quality care to our patients and ensuring a positive work environment for our employees. We have 2 positions available.One position that is full-time.Salary requires you to visit patients in the field for home care.Ann hospice in Wayne, Oakland and mccombnaughey's.The other position is for part time contractor

Posted 2 weeks ago

Sr. Engineer, Supplier QA-logo
Sr. Engineer, Supplier QA
LG Energy Solution ArizonaQueen Creek, Arizona
Empower Every Possibility. As one of the largest battery manufacturers in the world, LG Energy Solution aims to be an eco-friendly company that prioritizes the environment, fulfills its social responsibility, and creates sustainable future values. Located in Queen Creek, Arizona, LG Energy Solution Arizona, Inc. will lead production of LG's cylindrical batteries(EVs) in the North America. Come join us in an exciting adventure of awakening the world with energy! Title: Sr. Engineer, Supplier Quality Assurance (SQA) Reports to: Sr. Manager, Supplier Quality Assurance (SQA) Location: Queen Creek, AZ We awaken the world with Energy. LG Energy Solution Arizona, Inc. (LGESAZ) develops and manufactures cylindrical batteries for electric vehicles (EVs), the first such facility in the United States. Come join the leader in advanced IT and Mobility energy solutions to help us Empower Every Possibility! Company LinkedIn Summary : This position is responsible for ensuring that components meet established quality standards, including reliability, usability, and performance. The role directly supports manufacturing quality assurance by conducting failure investigations and root cause analysis, utilizing appropriate analytical methods, technical skills, and equipment. The Senior SQA Engineer is expected to communicate effectively across all levels of the organization to address and resolve quality-related issues in a timely and efficient manner. Responsibilities: Train production operators to perform inspections accurately in accordance with Standard Operating Procedures (SOPs) Analyze samples from in-line returns and field returns, and report to headquarters if defects are determined to be caused by component-related issues Lead comprehensive process investigations to improve process stability and capability for cell and module components/products, addressing issues from their root causes Maintain close communication and collaboration with cross-functional teams including Production, Purchasing, and other departments Communicate and present quality processes officially to relevant internal stakeholders to ensure understanding and compliance Maintain and manage laboratory and testing equipment to ensure accuracy and reliability of test results Engage in frequent communication with the quality team in the Netherlands to share findings and implement verified corrective actions received from headquarters and engineers Monitor and continuously improve Statistical Process Control (SPC) systems to ensure consistent product quality Conduct inspections and perform root cause analyses for non-conforming raw materials and finished products Manage nonconforming components by marking with identifier labels, initiating indemnity claims, and requesting rework as necessary Conduct surveillance audits for suppliers to ensure adherence to quality standards Review and approve Production Part Approval Process (PPAP) submissions and manage changes in the 4M (Man, Machine, Material, Method) process Identify defects during incoming inspections and take corrective actions promptly Ensure work environments remain safe, organized, and efficient at all times Support and promote a company culture centered on quality, open communication, collaboration, integration, and teamwork Maintain cleanliness at the worksite in accordance with 5S3R Standards: - 5S: Sort, Set in order, Shine, Standardize, Sustain - 3R: Right Location, Right Quantity, Right Container Perform other duties as assigned Qualifications and Requirements : Minimum of 7 years of experience in quality assurance, preferably in a manufacturing or production environment Bachelor’s Degree in engineering, quality or related field required Six Sigma certification preferred Experience in hi-volume production, Control Plans, PFMEAs, and process controls preferred Knowledge of International Automotive Task Force (IATF) 16949 standards Knowledge of Minitab, Six Sigma, Eight Disciplines Methodology (8D) problem solving Critical thinking and an analytical approach to problem solving Ability to travel domestic and internationally Ability to work flexible hours as needed to support related teams and work with headquarters and other global sites Must be able to properly and regularly utilize the following Personal Protective Equipment (PPE) for a period of up to 12 hours Safety glasses Steel-toed shoes Must be able to perform the following over the course of up to 12 hours per day Lift/push/pull up to 35 pounds on occasion Stoop, twist, bend Reach overhead Sit and/or stand for lengthy periods Skills: Must have demonstrated knowledge of Advanced Product Quality Planning (APQP), inspection equipment and techniques, root cause failure analysis, capability studies, statistical distributions, machine and assembly processes, problem solving, Process Flow Diagram (PFD) / PFMEA / Control Plan, PPAP, 8D / Five whys, team facilitation and geometric dimensioning and tolerance Knowledge and relevant experience in defining and understanding the roles of Standard Operating Procedures (SOPs), Control Plans, Critical to Quality (CTQs), and Parameters for conducting Process Audits Positive, dedicated attitude and demonstrated effectiveness to achieve given goals within due dates Strong written and verbal communication skills Demonstrates a strong sense of ownership by taking full responsibility for assigned tasks and ensuring their successful completion Demonstrate teamwork and effectiveness in accomplishing goals Ability to analyze data and prepare reports, statements, and projections Ability to apply logical thinking and scientific theories to approach problem causes, along with a commitment to continuous improvement and the ability to generate ideas Good capability to use MS-office and Minitab programs Experience with report writing in Microsoft Word and graphical analysis in Minitab strongly preferred Why should you work here? 1. You contribute towards more sustainable future 2. You are working with cutting-edge technologies 3. You will receive market leading Total Rewards Package 4. You will explore various Career Growth & Internal Advancement Opportunities EEO Statement LG Energy Solution Arizona, Inc. is an Equal Employment Opportunity Employer

Posted 30+ days ago

Endpoint QA Automation-logo
Endpoint QA Automation
ForcepointCampbell, California
Who is Forcepoint? Forcepoint simplifies security for global businesses and governments. Forcepoint’s all-in-one, truly cloud-native platform makes it easy to adopt Zero Trust and prevent the theft or loss of sensitive data and intellectual property no matter where people are working. 20+ years in business. 2.7k employees. 150 countries. 11k+ customers. 300+ patents. If our mission excites you, you’re in the right place; we want you to bring your own energy to help us create a safer world. All we’re missing is you! Forcepoint is looking for a highly experienced Automation Engineer to join our QA team in the Campbell, CA office . In this role, you will work testing and automation for the endpoint . The role requires both manual QA as well as the ability to automate the test cases to reduce the manual QA efforts and achieve higher efficiency. We are not looking for a standard manual QA tester, we are looking for an engineer with a strong System and IT background, that is capable of writing scripts using python or mac Automator or other macOS endpoint automation tools . The nature of the role requires an innovative mind that will be looking for ways to overcome the protection that we develop and to think and simulate how users work in different environments with many different products and means to send or copy data outside of the organization. Specific Responsibilities/Functions Understand customer environment/ behavior and create a detailed test plan Create a detailed Test design for new product features Create a detailed Test cases and test scenarios Understand the product/module requirement s and write detailed test plans . Write automation scripts for new features in python or power shell. Review product documentation and provide feedback Work and investigate new products and new versions of products (like Dropbox, WeChat, Syncplicity) to identify all new capabilities of products that DLP should protect. Investigate and learn new Operating system features and limitations like macOS BigSur to educate about new options for data theft that the product needs to protect Working on a tight schedule to meet customer needs on time. Work from the Campbell site up to four times a week as needed. Requirements : At least 5+ years’ experience in QA Automation Perl script development experience is a must have Automated testing experience by using VMWare based virtual environments Scripting Abilities – using Python , bash or another script/shall knowledge. Background in security technologies and products Experience working with one or more of the following AD Virtualization security servers Setup an Azure Information Protection Citrix XenApp | XenDesktop VMWare Horizon Forcepoint is committed to fair and equitable compensation practices. The salary range for this role is $116,100.00 - $134,500. 00 and represents the low and high end of compensation for this position. Actual salaries are determined by various factors including, but not limited to, location, experience, and performance. The range listed is just one component of Forcepoint’s total compensation package for employees. Other rewards may include bonuses, paid time off policy, and many region-specific benefits. Don’t meet every single qualification? Studies show people are hesitant to apply if they don’t meet all requirements listed in a job posting. Forcepoint is focused on building an inclusive and diverse workplace – so if there is something slightly different about your previous experience, but it otherwise aligns and you’re excited about this role, we encourage you to apply. You could be a great candidate for this or other roles on our team. The policy of Forcepoint is to provide equal employment opportunities to all applicants and employees without regard to race, color, creed, religion, sex, sexual orientation, gender identity, marital status, citizenship status, age, national origin, ancestry, disability, veteran status, or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity. Forcepoint is committed to being an Equal Opportunity Employer and offers opportunities to all job seekers, including job seekers with disabilities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access the Company’s career webpage as a result of your disability. You may request reasonable accommodations by sending an email to recruiting@forcepoint.com . Forcepoint is a Federal Contractor. Certain positions with Forcepoint require access to controlled goods and technologies subject to the International Traffic in Arms Regulations or the Export Administration Regulations. Applicants for these positions may need to be "U.S. Persons," as defined in these regulations. Generally, a "U.S. Person" is a U.S. citizen, lawful permanent resident, or an individual who has been admitted as a refugee or granted asylum. Applicants must have the right to work in the location to which you have applied.

Posted 30+ days ago

QA/QC Engineer-logo
QA/QC Engineer
LancoUnion City, Tennessee
We are looking for an experienced and driven Quality Engineer to work with us at Greenfield Products! This is an exciting role for someone who is passionate about engineering and Quality Engineering of final assemblies, incoming components, processes and documentation. Who we are: The most complete lifting company in the world, Lanco represents four iconic, world-class heavy equipment manufacturers, mobile crane dealerships across US and Canada, the largest parts and service network in North America, and factory-authorized technician training. In this role, you will support Greenfield Products, LLC , a leading manufacturer of a wide range of material handling solutions including crane and rigging accessories, forklift attachments, and port & rail equipment. Quality, through superior knowledge and professional experience, is the basis that we were built upon in 1991. By designing and engineering maintainable solutions that can integrate into daily operations without missing a beat, we provide our customers with reliable, safe, and efficient solutions. From the engineering department to the manufacturing floor, we are committed to providing a superior product and an unsurpassed customer experience. https://www.thelancogroup.com/our_services/material-handling/ https://www.greenfieldpi.com Position Overview: In this role as a Quality Engineer, you will directly support the operations at the Greenfield Products location in Union City, TN. You will champion the use of quality tools and problem-solving techniques to positively impact business performance and increase overall quality competency. You will be knowledgeable in all quality requirements and quality assurance processes related to specific job responsibilities. Essential Functions: Develops and applies advanced Quality Engineering theories, methods and research techniques in the development, establishment and maintenance of quality assurance/control policies, procedures and methods. Develops sampling plans, quality standards and quality control instructions to be utilized by manufacturing, test and inspection in assessing the quality levels of products and processes. Provides recommendations concerning the disposition of defective materials. Reviews corrective actions recommended on audit reports for adequacy and to maintain a continuing awareness of quality problems. Conducts investigations of considerable complexity pertaining to the manufacture of new products, the establishment of new processes or the resolution of complex product quality problems. Designs fixtures, and processes to ensure the continuing maintenance of product quality; may conduct vendor visits to insure quality; analyzes reports and returned products to determine trends and recommend corrective action Perform 1 st article inspections, ECN production introduction, vendor audits, and internal audits Responsible for the generation of a strategic plan to improve the business processes and increase production output. Duties include creating the company's quality standards and testing systems to reflect efficiency, reliability and performance. Responsible for the creation of documentation that reports issues and errors relating to the production process with efforts placed to find a solution. Monitoring and analyzing quality performance. Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. Additional Responsibilities: Ensure compliance in all safety, health, and environmental regulations, policies, and procedures for a goal of zero incidents and injuries Communicate consistently on all activities to appropriate individuals (both internal and external) Maintain ongoing communication and adhere to all Companywide policies to eliminate and/or reduce exposure to liability Special projects or work as assigned Please note this job posting is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. What we are looking for: Self-motivated, with the ability to work with minimal supervision in a team environment. Working knowledge of Microsoft computer applications. Ability to interview, audit, observe and document processes. Required Education and Experience: Degree in Engineering or Engineering Technology from a four-year college or university or equivalent combination of education and experience. Five (5) years related experience and/or training; or equivalent combination of education and experience Previous experience performing root cause analysis and implementing corrective actions Strong MS Excel skills, with ability to apply statistics, analyze data, and create metrics Preferred Education and Experience: Experience applying Quality standards in a manufacturing environment Demonstrated proficiency in leading Root Cause Corrective Action problem-solving activities that identify true root case and implement permanent corrective actions Lean experience Experience working within the ISO 9000 quality framework Organized with solid judgment; able to multitask and adjust to changing priorities Desire to identify continuous improvement opportunities and lead projects to make improvements to processes, procedures, etc. Strong communication and interpersonal skills; ability to interact with internal and external stakeholders including Senior Leadership Demonstrated ability to influence and build trust with suppliers, customers, and key stakeholders Demonstrated ability to build strong relationships, specifically in cross-functional teams 3-5 years of verifiable inspection experience. Work Environment: This is a production classification and employees work indoors and outdoors (in all seasons) with exposure to noise, chemicals, heavy equipment and machinery. Physical Demands: Accurate hand/eye coordination is required. Finger dexterity is required, as well as hand strength, with the ability to grasp, lift, push and pull. Work involves considerable climbing, twisting, bending, squatting and kneeling for long periods of time. May lift parts weighing up to 50 pounds and pull approximately 20 lbs. Need to have the ability to ascend and descent a ladder and/or scaffolding. Compensation/Benefits: We foster a collaborative team environment that values innovation and encourages creative solutions to drive positive organizational impact. Our employees are the key to our success and help us stand out from our competitors. The base salary range for this role is $70,000.00 to $90,000.00 per year. The final compensation offer may vary based on factors such as experience, education, skills, and location. We offer competitive pay, paid time off, and comprehensive benefits, including medical, dental, vision, life insurance, and a 401(k) plan. Lanco is an equal employment opportunity employer. All employment-related decisions, including but not limited to hiring, compensation, promotion, discipline (including termination), evaluation, training, and development opportunities, etc., are made without discrimination based on race, color, sex, sexual orientation, gender-related identity, pregnancy, national origin, ancestry, religion, age, military status, protected disability, citizenship, genetic information or any other category protected by applicable law.

Posted 30+ days ago

Construction QA/QC Specialist – Disaster Recovery-logo
Construction QA/QC Specialist – Disaster Recovery
ICForporatedTallahassee, Florida
Join the ICF team and make a difference! Our growing Disaster Management Division makes BIG things happen every day. ICF is seeking a Construction QA/QC Specialist to assist the State of Florida with managing federal disaster recovery grant programs and carrying out strategic, high-impact activities to rebuild housing, strengthen communities, and mitigate future disaster risks. The Construction QA/QC Specialist will perform day-to-day quality assurance and quality control activities to support residential construction, rehabilitation, reconstruction, and mitigation efforts funded through the Community Development Block Grant – Disaster Recovery (CDBG-DR) and Community Development Block Grant – Mitigation (CDBG-MIT) programs. This position requires a strong attention to detail, critical thinking, and the ability to adjust to an ever-changing environment. Key Responsibilities: Perform QA/QC reviews of inspection reports, scopes of work, cost estimates, builder invoices, and milestone inspections. Verify that all construction documentation is accurate, complete, and consistent with approved project scopes. Ensure environmental compliance requirements (lead-based paint, asbestos, mold, Section 106 compliance) are properly incorporated into scopes of work. Review and validate builder invoice submissions for accuracy, completeness, and cost reasonableness. Assist in maintaining document control and proper filing of all construction and inspection documentation in the system of record. Coordinate with Damage Assessors, Construction Managers, and other field staff to resolve inconsistencies and deficiencies in construction documentation. Support quality assurance audits, inspections, and field verification activities as needed. Identify potential risks or discrepancies and escalate findings to the Construction QA/QC Lead for resolution. Other tasks, as assigned. Minimum Qualifications: Associate’s degree or equivalent combination of education and relevant work experience. 1–3 years of experience supporting residential construction, inspections, damage assessments, or QA/QC activities. Experience working with CDBG-DR, CDBG-MIT, or other federally funded construction programs. Proficiency with Xactimate X or later versions for damage assessments and cost estimating. Knowledge of IRC 2021, IBC 2021, Florida Building Code, and resilient residential construction practices. Strong proficiency in Microsoft Excel, Word, and document management systems (e.g., SharePoint, QuickBase, Salesforce). Excellent organizational skills and attention to detail. Ability to manage multiple tasks simultaneously and work independently or collaboratively within a team environment. Other Job Details: Remote position with possible occasional travel to field offices, client sites, and housing centers throughout Florida. Full-time position. Working at ICF ICF is a global advisory and technology services provider, but we’re not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future. We can only solve the world's toughest challenges by building a workplace that allows everyone to thrive. We are an equal opportunity employer . Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO policy. Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation, please email Candidateaccommodation@icf.com and we will be happy to assist . All information you provide will be kept confidential and will be used only to the extent to provide needed reasonable accommodations. Read more about workplace discrimination righ t s or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act. Candidate AI Usage Policy At ICF, we are committed to ensuring a fair interview process for all candidates based on their own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) tools to generate or assist with responses during interviews (whether in-person or virtual) is not permitted . This policy is in place to maintain the integrity and authenticity of the interview process. However, we understand that some candidates may require accommodation that involves the use of AI. If such an accommodation is needed, candidates are instructed to contact us in advance at candidateaccommodation@icf.com . We are dedicated to providing the necessary support to ensure that all candidates have an equal opportunity to succeed. Pay Range - There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position based on full-time employment is : $66,701.00 - $113,391.00 Florida Remote Office (FL99)

Posted 3 days ago

DON- registered nurse with QA experience-logo
DON- registered nurse with QA experience
University Home CareLivonia, Michigan
Job Description - DON - Registered Nurse with QA Experience Description of the role: University Home Care is seeking full time or part time dynamic and Director of Nursing (DON) who is a registered nurse with quality assurance (QA) experience. The DON will play a crucial role in providing leadership, guidance, and oversight to the nursing team. Responsibilities: Manage and supervise nursing staff Ensure compliance with all relevant healthcare regulations Develop and implement quality assurance programs Oversee patient care plans and ensure their effectiveness Provide training to staff as needed Monitor and evaluate the performance of the nursing team Requirements: Registered Nurse (RN) license Minimum of 1 years of experience as QA Strong knowledge of quality assurance principles and practices Excellent leadership and communication skills Ability to work effectively in a fast-paced environment Benefits: Competitive compensation package Healthcare benefits Paid time off Retirement plans Professional development opportunities About the Company: University Home Care is a leading provider of high-quality in-home healthcare services in Livonia, Michigan. Our mission is to enhance the well-being and quality of life for our patients by delivering exceptional healthcare with compassion, integrity, and excellence. We pride ourselves on fostering a positive and supportive work environment that values teamwork, innovation, and continuous professional growth.

Posted 30+ days ago

Senior QA Engineer-logo
Senior QA Engineer
CodalLincoln, Nebraska
An Introduction to Codal Codal is an award-winning web design and development consultancy that helps enterprise organizations solve complex problems and accelerate growth through elegant, data-driven digital solutions. Our areas of expertise include application modernization, eCommerce, UX/UI design, product strategy, data analytics, and artificial intelligence. At Codal, you’ll collaborate with some of the most innovative organizations in the world and work on cutting-edge technologies that push the boundaries of design and software development. You’ll also be part of a community that promotes long-term success, not just for our clients but for each other. We’ll help you develop a professional roadmap that takes your career to new heights. Who you’ll be working with We build the solutions dreamed up by the product and design teams. Our goal is to deliver working software every two weeks. We are a large team that spans across three global offices, but we collaborate and integrate front- and back-end components and interfaces to provide a user-centered experience through web and mobile platforms. What you’ll be doing Analysis of requirements, writing and executing test cases to detect usability and performance issues. Conducting test design, execution, and exploratory testing. Bring a strategy-based approach to testing. Creating detailed reports and listing improvements. Participation in test planning meetings and providing feedback to the testing team, reviewing requirements specifications and technical design documents to provide timely and meaningful feedback. Estimate, prioritize, plan, and coordinate testing activities, and work closely with product and development teams to produce high-quality software. What you’ll need to be successful (Requirements) This is NOT a remote position and candidates must live within a commutable distance of Lincoln, Lincolnshire, UK Minimum 4 years experience in web /mobile/API/ requirements testing. Strong UI/UX background. Experience with software testing methods, such as functional testing, end-to-end testing, and sanity/regression testing. Expertise in writing test documentation, requirements review, and creating bug reports. Ability to describe bugs clearly and accurately. Basic experience in SQL and scripting. Strong knowledge of Test Methodologies, SDLC (Agile, Scrum,), STLC, and Bug Life Cycle. Experience with management tools. Jira, X-Ray, Zephyr. Strong organizational skills and ability to handle priorities. Experience handling a small team is a plus Excellent communication skills. Benefits and Salary: £45,000 - £60,000 dependant on experience Training opportunities and incentives – we support professional certifications across engineering and non-engineering roles; Industry leading health and wellbeing plan - including eye-health and dental-care; Private healthcare (family plans available); Life Assurance (6 x annual salary); 30 days holiday inclusive; A cash-payout referral scheme; Parking / Commute privileges Paid conference attendance days Need another reason to hit the “apply” button? Codal is a global agency with over 200 employees, and offices in the US, UK, and India We regularly host happy hours, dinners, excursions, and other company events to unwind after a hard day at work Office snacks and drinks An office in the heart of digital Lincoln Working hybrid for in-person collaboration and sprint-planning days Note: Codal only communicates with candidates through official @codal.com email addresses. We never request payment during the hiring process. Please be vigilant regarding recruitment scams. At Codal, we are committed to equal employment opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Posted 30+ days ago

QA Specialist-logo
QA Specialist
Globus MedicalSan Antonio, Texas
Bone Bank Allografts, a subsidiary of Globus Medical Inc., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus’ renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution. The Position Summary: The Quality Assurance Specialist works within the Quality Department to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the QA Specialist is to provide review and release of product records to ensure compliance to company procedure and applicable federal, state, local, and accreditation standards. Essential Functions: Perform data entry review and release ensuring entry of finished goods coincides with the Distribution software Perform secondary review of Donor Processing Records for terminally sterilized and aseptic lines Coordinate with the QA Systems Team Lead or Management to prioritize product release Perform release functions to finished goods Review test reports as part of release criteria Review technical and performance specifications Review irradiation shipment documents for acceptability Verify domestic or international requirements for product release Investigate and track status of records pending release Assist in onboarding new private label clients by verifying label requirements prior to use Assist Distribution department with the review and release of re-designated products as requested Perform Quality review of assigned records or logs and verify procedure requirements were met for approval and closure of the records Maintain error spreadsheets and create graphs/trending reports as needed Assist with performing the monthly inventory of QA product Report non-conformances and discrepancies. Participate in continuous improvement initiatives and implementations. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications: Bachelor’s degree preferred. Experience performing file reviews and/or audits. QA or QC experience within the biotech/tissue banking industry preferred. Knowledge of GMP regulations preferred Must be knowledgeable with Microsoft Word and Excel programs. Strong typing skills, analytical skills, and problem solving techniques. Excellent communication and writing skills. Physical Demands : The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Required to sit; climb or balance; and stoop, kneel, crouch or crawl Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus Our Values : Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven. Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate about our role in improving the lives of patients by continuously developing better solutions. Customer Focused : We listen to our customers’ needs and respond with a sense of urgency. Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger. Driven : We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. Equal Employment Opportunity : Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. Other Duties : Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Posted 1 week ago

QA Technician B Shift-logo
QA Technician B Shift
Jbs UsaGreeley, Colorado
Description Position at JBS USA Description QUALIFICATIONS: Ability to communicate effectively in English, both written and verbally. Excellent customer service skills. Production experience preferred in a food processing facility. High School degree or equivalent preferred but not required. Must attach resume RESPONSIBILITIES: Monitor and evaluate quality levels of product, areas, and people. Ensure all company safety guidelines are being followed. Follow all food safety requirements. Work closely with management to achieve production objectives. Perform various other duties as needed or assigned. The applicant who fills this position will be eligible for the following compensation and benefits: Benefits: Vision, Medical, and Dental coverage begin after 60 days of employment; Paid time off: sick leave, vacation, and 6 company observed holidays; 401(k): eligible after 1st day of employment including company match which begins after the first year of service and follows the company vesting schedule Base pay is $23.25/hr The company is dedicated to ensuring a safe and secure environment for our team members and visitors. To assist in achieving that goal, we conduct a drug, alcohol, and background checks for all new team members post-offer and prior to the start of employment. The immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. EOE, including disability/vets

Posted 1 week ago

QA Sr. Supplier Specialist-logo
QA Sr. Supplier Specialist
GeneFabAlameda, California
The QA Supplier Specialist plays a crucial role in ensuring that the raw materials used in the manufacturing of drug products meet the necessary quality standards. This position is responsible for managing project objectives by planning and evaluating activities related to sourcing, qualification, audit, and life-cycle management of suppliers. The QA Supplier Specialist will support various Quality Assurance project initiatives, respond to Regulatory and Partner inquiries, and manage Specifications, as well as audit activities that pertain to Supplier Quality, Quality Management, and Supplier Performance. Responsibilities Lead the qualification, approval, and on-going monitoring of suppliers and contract testing labs (CTL) Conduct risk assessments for new and existing suppliers Perform on-site and remote audits to assess supplier compliance with GMP, GxP and applicable regulatory requirements (e.g. FDA, EMA, MHRA) Ensure accurate and timely qualification of materials. Manage and track Supplier Corrective Action Requests concerning raw materials, single use materials, packaging components, etc. Collaborate with internal stakeholders to resolve supplier-related quality issues. Draft, negotiate, and maintain quality technical agreements with key suppliers Ensure supplier-related changes are managed through appropriate change control processed Work closely with internal teams (project teams, manufacturing/MSAT, to ensure timely supply chain operations.) Maintain supplier quality documentation including audit reports, qualification files, and performance metrics Perform continuous improvement of the program using methodologies such as QRM and Lean. Gather, evaluate, and present information/documentation for regulatory inspections and inquiries, as well as partner and internal audits. Prepare and complete action plans; implement efficiency, quality, and customer service standards. Resolve problems, identify trends, and determine system improvements; implement change within GMP guidelines. Maintain project timelines associated with quality assurance initiatives. Requirements Bachelor's degree in engineering, life sciences, logistics, or a related field. (Master’s or advanced degree preferred.) 7+ years of quality experience in the pharmaceutical or biotechnology industry with at least 4 years in a supplier quality or auditing role. Auditor certification preferred (ASQ, CQA. Etc). Strong knowledge of quality systems, risk management, and supplier audit practices. Demonstrated ability to manage complex supplier networks and work cross-functionally in a fast-paced, regulated environment Experience supporting cell and gene therapy preferred Previous experience working in a start-up or growth-phase CGT company Proven experience may substitute for education requirements. Qualifications relevant to the role will determine the level. $40 - $60 an hour

Posted 30+ days ago

Software QA Engineer-logo
Software QA Engineer
Raymond JamesPittsburgh, Pennsylvania
Job Description Summary of the Position: Technology professional responsible for assuring delivery of high-quality software by planning, designing, implementing, and automating software QA testing for both in-house developed and vendor licensed software. Responsibilities include understanding requirements, developing test plans for software releases, creating and executing test cases, writing and maintaining test automation code and reporting results. The role will also be responsible for developing meaningful QA metrics to track and monitor progress with improvements in test coverage, defect minimization and overall quality. Primary Functions of the Position: Plan and implement testing (e.g., regression, functional, data validation, system integration, API, load, or performance tests) for new and existing functionality. Work closely with external software package vendors, in-house development partners and business product groups to refine product requirements, identify user scenarios, design testing strategies and integrate testing into the product design and development process. Plan, create, execute, and automate test cases, working with business partners, developers, and other stakeholders. Document and analyze test results and recommend corrective action. Isolate, reproduce, manage, and maintain defects and test case databases, and verify fixes. Support user acceptance testing (UAT) conducted by business partners or end users. Design testing and risk analysis approaches for complex features (functionality that span across platforms or teams). Identify opportunities to reduce testing time and effort by automating repeatable tests, integrating test capabilities with CI/CD development pipelines. Develop and maintain a library of automated test cases that can be executed in a repeatable fashion to improve quality, minimize unforeseen failures, and improved efficiency when introducing vendor software releases into test and production environments. Enhance and maintain the test automation framework. Understand and apply automated testing best practices. Employ software engineering and test automation best practices to ensure automation test suites are robust and maintainable. Review developers’ test plans to ensure comprehensive test coverage. Education and Experience Requirements: BS or MS Degree in Information Science or Computer Science 5+ years of experience in a Software Development Engineer in Test (SDET) or Test Automation engineer role. Experience with test automation and test automation frameworks (e.g., Selenium, Cypress, Robot Framework, Cucumber, Postman). Experience with test management tools (e.g., HP ALM/Quality Center, TestRail, Xray, TestMonitor) Proven ability to maintain code repositories with Azure DevOps, Gitlab or similar. Experience or exposure to financial services technology and banking preferred. Essential Skills and Abilities: Software development experience. Proficiency in Selenium, Java/Python, JavaScript Experience building/maintaining automation frameworks, and writing test automation scripts Experience with SQL Experience designing and implementing test plans Experience with application performance monitoring and observability tools. Attention to detail and ability to identify, isolate and document defects. Strong knowledge of agile practices and experience with agile planning tools (e.g., Jira). Strong leadership skills. Effective communication skills for both technical and non-technical audiences. Collaboration skills and ability to work on a team. Adaptability and willingness to learn. Education Bachelor’s: Accounting, Bachelor’s: Business Administration, Bachelor’s: Computer and Information Science Work Experience General Experience - 3 to 6 years Certifications Travel Workstyle Resident At Raymond James our associates use five guiding behaviors (Develop, Collaborate, Decide, Deliver, Improve) to deliver on the firm's core values of client-first, integrity, independence and a conservative, long-term view. We expect our associates at all levels to: • Grow professionally and inspire others to do the same • Work with and through others to achieve desired outcomes • Make prompt, pragmatic choices and act with the client in mind • Take ownership and hold themselves and others accountable for delivering results that matter • Contribute to the continuous evolution of the firm At Raymond James – as part of our people-first culture, we honor, value, and respect the uniqueness, experiences, and backgrounds of all of our Associates. When associates bring their best authentic selves, our organization, clients, and communities thrive. The Company is an equal opportunity employer and makes all employment decisions on the basis of merit and business needs.

Posted 2 days ago

QA / Test Automation Engineer-logo
QA / Test Automation Engineer
Pioneering EvolutionArlington, Virginia
POSITION DESCRIPTION: Pioneering Evolution is seeking a skilled QA / Test Automation Engineer to ensure system quality, audit readiness, and compliance for a secure federal software platform. This role is responsible for designing and implementing automated testing strategies that validate application behavior and performance against mission requirements. The ideal candidate will work closely with development, DevOps, and documentation teams to establish traceability, manage defects, and support audit documentation through reliable and efficient test practices. Other key responsibilities include: Develop and maintain automated unit, integration, and regression test suites to support CI/CD pipelines and release cycles. Create detailed test plans, acceptance criteria, and traceability matrices to align with functional, security, and compliance standards. Validate application functionality and behavior across user workflows, edge cases, and secure configurations. Collaborate with developers and DevOps engineers to integrate testing tools, support defect resolution, and maintain quality throughout the SDLC. Manage test data sets, track and document defects, and communicate quality metrics to stakeholders. Provide test evidence and artifacts for audit documentation and compliance reviews. REQUIRED EXPERIENCE: Bachelor’s degree in Computer Science, Engineering, or a related technical discipline. Minimum of 5 years of QA experience, with a focus on test automation for large or complex software systems. Proficiency with testing frameworks such as Selenium, Cypress, or similar tools, as well as API testing solutions. Strong understanding of quality assurance in secure and compliance-driven development environments. Excellent written and verbal communication skills and the ability to collaborate across disciplines. Must be available to work full-time and on-site in the Washington D.C. metro area. U.S. Citizenship and active Secret Clearance are required. DESIRED EXPERIENCE: Experience applying federal testing standards or compliance-focused QA practices. Familiarity with performance testing, security testing, and risk-based validation strategies. Understanding of Agile QA methodologies and tools supporting test traceability and continuous integration. WHO WE ARE AND WHAT WE OFFER: In addition to competitive salaries and opportunities for professional development and advancement, our employees enjoy a comprehensive range of benefits. To keep pace with the changing needs of our employees, we continually evaluate benefit plans. Paid time off 10 paid holidays Medical insurance Dental insurance Vision insurance Legal assistance Company-paid life insurance and AD&D Company-paid long term and short-term disability insurance Tuition reimbursement 401(k) plan with company contribution Continuing Education Opportunities

Posted 2 days ago

QA Tech-logo
QA Tech
AlphiaPittsburg, California
Job Description: JOB PURPOSE: The Level I QA Technician position is intended to be a “starting” point, from which the technician is expected to advance to capability on both sides of the process before the two year “target .” The Level I Technician should be capable of the required sampling and testing on either the processing or packaging side of the process with some assistance from the other QA technicians or leads . The Level I Technician should have a good working knowledge of Food Safety and Quality policies . DESCRIPTION OF ESSENTIAL DUTIES: Analytical Instruments : Operate the NIR, Aw meter, CompuTrac moisture analyzer, calipers, LECO, laboratory weigh scales, vacuum chamber for seal checks (PC), thermometers and other equipment as added. In-Process Sampling and Testing : Completes all routine tests for either Processing side or Packaging side. Quality Hold Know and be able to place materials and product on Hold in X3 and physical Hold, and complete Log and Hold report. Business Systems : Enter data collected from routine tests into IQS software. Knowledge and proficiency in all Alphia Business Systems as relates to Position. Food Safety and Sanitation : Know and follow basic GMP requirements. Know and monitor HACCP compliance in-Process. Perform verification checks of metal detectors and magnets in area of responsibility as specified in Quality Checkpoints . Assist with product changeover cleaning and sanitation; perform inspections before product startup. Microbial Testing : Pull finished product samples for product release testing. Regulatory Requirements : P ull samples for testing as in product specifications. Communication: Informs operators and shift supervisor of testing results. Communicates Quality concerns and Quality status to the following shift. Responsible for following established procedures to ensure that Alphia produces safe, quality food, meeting all governmental regulations. Other duties as directed or assigned. QUALIFICATION REQUIREMENTS: ( To perform this job successfully, an individual must be able to perform each essential duty satisfactorily . The requirements listed below are representative of the knowledge, skill, and/or ability required). Education level: high school diploma or GED . Willing to work in a team environment and contribute to group goals. Excellent communication skills Ability to receive and provide instructions positively. Basic math skills Ability to multi-task. PHYSICAL DEMANDS: ( The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job . Reasonable accommodation may be made to enable individuals with disabilities to perform the essential function . The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “occasionally” means up to 25% of working time, “regularly” means between 26 and 75% of working time, and “frequently” means 76% and more of working time.) While performing the duties of this job, the employee is regularly required to talk or hear, walk, and move from place to place . The employee is occasionally required to sit, use foot/feet to operate machine, stoop, kneel, crouch or crawl or reach above shoulders . The employee is frequently required to stand and use hands to finger, handle, or touch . The employee must be able to climb stairs and ladders. The employee must exert 20 to 50 pounds of force occasionally, and / or up to 10 to 25 pounds of force frequently , and / or greater than negligible up to 10 pounds of force constantly . Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. WORK ENVIRONMENT: ( The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job . Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions). The employee may be frequently exposed to allergens and/or airborne particles in the production area . Production employees are exposed to temperatures ranging from 50 to 115 degrees, depending on the season and workstation, and may be working near moving mechanical parts. Occasional exposure to outdoor weather conditions may occur. The noise level in the work environment may be loud while production equipment is running. Personal Protection Equipment (including boots, gloves, safety glasses, and/or face shields) is during various processes in the production area. Ear plugs and bump caps are always in the production area. The above statements reflect the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation. Alphia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Posted 2 days ago

Lead Specialist, QA Validation & Engineering-logo
Lead Specialist, QA Validation & Engineering
CatalentHarmans, Maryland
Lead Specialist, QA Validation & Engineering Catalent Pharma Solutions is looking to hire a Lead Specialist, QA Validation & Engineering to support our growing team in Harmans, MD Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location . The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. The Lead Specialist, QA - Validation & Quality Engineering is responsible for providing Quality oversight of Catalent’s Facilities, Engineering and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Catalent policies/procedures supporting the commercial GMP manufacturing of biological drug substance and drug product. This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Facilities and Validation organizations. This is a full-time onsite position working Days; Monday – Friday, 8am-5pm. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role Serve as the QA liaison with the Facility, Engineering and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a general resource. Interface and communicate with the Client, Validation, Engineering and Facilities departments in meeting project timelines, providing deliverables and resolving issues. Represent Quality in client/stakeholder meetings regarding new projects and establishing timelines. Lead projects from the planning stage to completion in a Quality role. Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity. Review and approve Protocols and Summary Reports for Process Validation such as PPQ’s, Engineering studies, Cleaning Validation, etc. Review and approve equipment qualification protocols such as IQ/OQ/PQ for various equipment such as bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves and critical utilities. Support review of the facility Validation Master Plan (VMP). Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools. Serve as the QA resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI) and EMPQ of cleanrooms. Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities Provide QA support to the Calibration Program, including review and approval of new calibration plans/procedures, completed calibrations, and compliance to the calibration schedule. Provide QA support of the Maintenance Program, including QA review and approval of Preventive Maintenance (PM) plans/procedures ensuring their content and frequency are suitable for the intended application. Review and approve Standard Operating Procedures (SOPs). Participate in site and corporate quality and process improvement initiatives. Support regulatory (FDA, EMA, PMDA, ANVISA, etc.) and client audits/inspections of Catalent. Other duties as assigned. The Candidate Masters’ degree in a Scientific, Engineering or Biotech field with 6 years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality function OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 8 plus years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality function. Experience performing/supporting validations associated to IQ, OQ & PQ for Controlled Temperature Units (CTUS’s) such as freezers, refrigerators, incubators, autoclave and biologics manufacturing equipment. Experience with Facility Expansion and Aseptic Processing is a plus. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs Experience in writing deviations and investigations. Able to work in a team setting and independently under minimum supervision SME/Expert in all Microsoft Applications i.e. EXCEL, PowerPoint, Access, Teams and SharePoint Proficient with electronic systems, including developing and producing reports and can quickly learn and navigate new electronic systems Ability to work in fast paced environment supporting the quality assurance/facilities/engineering departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product. The anticipated salary range for this position in Maryland is $ $118,720 to $163,240 plus an annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should Join Catalent Potential for career growth within an expanding team. Defined career path and annual performance review & feedback process. Cross-functional exposure to other areas within the organization. Medical, Dental, Vision, and 401K are all offered from day one of employment. 152 hours of PTO and 8 paid holidays. Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .

Posted 1 week ago

QA Manager-logo
QA Manager
PCI Pharma ServicesMadison, Wisconsin
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The QA Manager is responsible for oversight of all daily functions of the quality system. Directly Supervise Documentation Control, QA Associates and Trainer, and act as backup and support to their activities. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Work directly with the Sr. Director, Quality on continuous improvement activities. Responsible for ensuring that client specifications are met during materials receipt, Drug / Device processing and final product shipment. Responsible for ensuring that procedures are followed and quality standards are met. Works directly with the Sr VP of Quality to evaluate products and materials for compliance to specifications. Oversight for established quality systems (Document Control, CAPA, Deviation, Environmental Monitoring, Change Control, Complaint, Calibration, Documentation, Training, Component Control, Batch Record Review, Label Control, Product Release). Review/approval of Validation Protocols (master and final reports). Approval of Deviations and CAPAs. Responsible for Environmental Monitoring and WaterTrend Reports. Provide QA Staff support (and backup) including: Scheduling updates and assignment of duties. Documentation Control prioritization: document processing, batch record issuance, change control issuance. Training: issuing notifications for training needs, maintenance of training files, initiating core training for new employees, present training to personnel as needed. Operations: provide line clearances and documentation as needed. Product and Materials Records Review: batch record review and release, materials review and approval, including - calibration, water testing, environmental monitoring, temperature and humidity review. Work Environment: Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Educational and Professional Experience: University degree in a related science discipline with 7 to 10 years experience in an FDA regulated Pharma or Biotech industry. Must have prior supervisory experience. Personal Skills & Competencies: Excellent organizational skills required. Strong oral and written communication skills required. Detail oriented. Ability to multi-task, flexibility is required. Computer skills (Excel, Word, Access, and PowerPoint) #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Posted 30+ days ago

Associate, QA Frontline-logo
Associate, QA Frontline
BioMarin PharmaceuticalNovato, California
Description Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Duties Alternate Weds, Thursday - Saturday 0600-1900 -Provide on-the-floor QA oversight and support to manufacturing operations -Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations -Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations -Represent QA in support of deviations including active participation in Root Cause Analysis (RCA) -Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel -Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies -Perform area walkthroughs -Perform other duties and projects as assigned by management Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands. Skills -Prior batch record execution or review experience -Prior experience in investigation, change control, other Quality Management Systems (QMS) -Working knowledge of cGMPs -Excellent written and verbal communication and interpersonal skills -Must display strong analytical and problem-solving skills -Manufacturing and Manufacturing Sciences experience preferred Education B.S. in scientific discipline or equivalent work experience. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Posted 30+ days ago

QA Tech- Night Shift $24.50-logo
QA Tech- Night Shift $24.50
Coca-ColaAuburndale, Florida
Location(s): United States of America City/Cities: Auburndale Travel Required: 00% - 25% Relocation Provided: No Job Posting End Date: June 12, 2025 Shift: Third Shift (United States of America) Job Description Summary: As the world’s largest beverage company, we produce the highest quality products, which our consumer has come to expect from us. We are currently seeking Technicians to join our manufacturing team in a Quality Assurance role. You’ll be responsible for quality testing of ingredients and finished products to ensure product and package integrity in accordance with standard operating procedures. We’re seeking team-oriented individuals who have a keen eye for the details and have a passion for ensuring the quality of their work. What You’ll Do for Us Perform collection, documentation, and destruction of samples, along with physical, chemical, and microbiological testing of finished products and raw materials. Communicate effectively and thoroughly to management and peers on test results or inspection findings outside of specifications. Conduct environmental sampling and analysis to monitor facility sanitation. Conduct all laboratory testing with accuracy and integrity and ensures that it is accomplished in compliance with all federal, state, and company policies and procedures. Keep accurate, complete, and legible records. Properly amend, identify, and file records, along with conducting clerical duties including copying, filing, faxing, data entry, and document reproduction. Safely handle/use chemicals, biological agents, and waste. Potentially including hazardous materials. Read, understand, and maintain material safety data sheets. Perform routine maintenance tasks on process equipment and monthly audits on various areas under laboratory control. Complete work orders to ensure proper maintenance, verification, calibrations are completed in a timely manner in accord with company, federal and state requirements Utilize software including word processing, spreadsheets, and inventory control systems. Set-up and calibrate test equipment. Monitor all quality checks made by production. Keep accurate Q.A. reports daily. Operate and perform quality tests on the treated water system. Qualification & Requirements High school diploma , GED equivalen t, Associate degree, or technical college degree . 1 + years’ experience in quality testing or manufacturing environment preferred. Must be able to maintain a strong level of confidentiality – all formulas are confidential . Solid math skills are required along with basic reading and writing skills . Must successfully pass Aon (behavioral/personality test) assessment test . Ability to demonstrate capability of learning or using b asic lab’s equipment such as: Refractometer, pH meter, Auto titrator , Density Meter, Turbidity Meter . Must have strong problem-solving skills and the ability to work efficiently under stressful situations . Comply with all Safety, Environmental, Security, and Good Manufacturing Practice policies. Microsoft office experience Ability to read equipment operations manuals. Ability to visually identify and recognize material, part, and product defects. Ability to participate in job development training Ability to work in a team environment. The Coca-Cola Company will not offer sponsorship for employment status (including, but not limited to, H1-B visa status and other employment-based nonimmigrant visas for this position. Accordingly, all applicants must be currently authorized to work in the United States on a full-time basis and must not require The Coca-Cola Company's sponsorship to continue to work legally in the United States. Skills: Pay Range: $51,480 - $62,920 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. Our Purpose and Growth Culture: We are taking deliberate action to nurture an inclusive culture that is grounded in our company purpose, to refresh the world and make a difference. We act with a growth mindset, take an expansive approach to what’s possible and believe in continuous learning to improve our business and ourselves. We focus on four key behaviors – curious, empowered, inclusive and agile – and value how we work as much as what we achieve. We believe that our culture is one of the reasons our company continues to thrive after 130+ years. Visit Our Purpose and Vision to learn more about these behaviors and how you can bring them to life in your next role at Coca-Cola. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. When we collect your personal information as part of a job application or offer of employment, we do so in accordance with industry standards and best practices and in compliance with applicable privacy laws.

Posted 1 week ago

QA Tech 1 - 1st Shift-logo
QA Tech 1 - 1st Shift
BA Candidate GatewayIrwindale, California
Title: QA Tech I -1 st shift Department: Quality Location: Irwindale, CA Shift: 1st shift Pay rate: $20.50 an hour Reports to: QA Lead Position Summary: The QA Tech 1 is a key Quality Assurance role within the plant and supports QA team leads in safeguarding compliance with food safety and quality requirements. As a QA Tech 1 at Bonduelle Fresh Americas (“BFA”), you will embrace our vision of Giving People the Freedom to Eat HealthierTM through excellence and daily performance of essential quality assurance functions, including finished goods checks and sampling for PCT testing (Hold & Release products). What if your job had a real impact? By joining Bonduelle, the world leader in ready-to-use plant-based food, you are deciding to make a positive and sustainable impact on yourself, others and the planet. You will play an active part in our mission: "inspire the transition toward a plant-based diet to contribute to people's well being and planet health". Bonduelle is a family-run company of 14,600 people which provides over 100 countries with vegetables. Well established in the United States, our business unit includes 4 production facilities with more than 3,200 associates. We process fresh vegetables, salads and meal solutions with our own brands: Ready Pac Foods® and Bistro®. Join us at Bonduelle to start an adventure where people come first and contribute to a better future through plant-based food! Bonduelle Fresh Americas is a Certified B Corp for a better life. Bonduelle chose B Corporation because of its comprehensive and rigorous standards and its ability to measure a company’s governance as well as worker, community, and environmental impact.We aim to make a positive impact on People, Planet and Food, as seen in our global B!Pact objectives. B Corp certification validates our positive impact and tells the world we are part of a community using business as a force for good. Key Responsibilities: Ensure compliance with and maintain all GMP/PPE/Safety, HACCP & Sanitation guidelines and processes. Understand and implement requirements for product sampling and sample product following PCT sampling procedures established by the customer and corporate QA. Sample finished product for Hold & Release PCT sampling as required by customers; prepares logs and submits samples for Hold & Release tests. Conduct seal integrity tests on finished products and ensure PMOs/SMOs perform equipment adjustments as needed to ensure 100% compliance with seal integrity. Identify any and all non-conformances, document and report it to the PMO/SMO and production leads for immediate follow-up; correct abnormalities and restore functioning where needed. Clean and/or fill-up the Haug tank at the start of every shift and maintain tank water level and cleanliness throughout the shift. Log leaks, non-conformances and sample submissions in the QA database. Perform other duties as assigned. Minimum Qualifications: Strong attention to detail. Ability to read, write and speak English; comprehension of basic math. Basic computer skills and ability to multitask. Willingness and flexibility to work in a cold, wet, fast-paced, 24 hour plant environment. Ability to lift up to 50 pounds, ability to climb stairs numerous times a day. Ability to work independently and in a team environment. GED/High School Diploma. Physical Work Environment: While performing the duties of this job, this position entails use of ladders and catwalks to reach production equipment, regularly works near moving mechanical parts and is regularly exposed to extreme cold for extended periods of time. The associate frequently works in high, precarious places. The associate is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually loud.

Posted 30+ days ago

KBI Biopharma logo
QA Manufacturing Specialist I/II
KBI BiopharmaDurham, North Carolina
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Job Description

Position Summary:

We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. 

You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI’s values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve.  As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation.  We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach.  We hope you join us!

Position Responsibilities:

  • Be an on-the-floor quality partner working with the manufacturing team during operations

  • Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues

  • Conduct QA walkthroughs

  • Participate in safety walkthroughs

  • Participate in process improvements

  • Attend relevant meetings in support of manufacturing operations

  • Review electronic batch records and logbooks

  • Provide feedback on facility response for unplanned events

  • Other tasks and projects as assigned

  • Work 12-hour shifts (2-2-3 schedule, day shift)

Position Qualifications:

MQA Specialist I 

  • High School diploma or equivalent. 
  • Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). 
  • Demonstrated ability to work in a team environment. 
  • Demonstrated ability to understand the manufacturing process. 
  • Ability to perform routine core MQA responsibilities. 

MQA Specialist II

  • Associate degree / bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-5 years).
  • Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. 
  • Demonstrated ability to represent Quality on interdepartmental meetings. 
  • Demonstrated knowledge of technical documents. 
  • Ability to support internal and external audits. 
  • Demonstrated ability to train employees on Quality subjects. 
  • Ability to track and trend department metrics

 

Salary Ranges:

MQA Specialist I: $54,000 - $74,300

MQA Specialist II: 66,966 - 92,077

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.  

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.