Quality assurance lead jobs in Bethlehem, PA

Must Have Technical/Functional Skills We are seeking a highly skilled and proactive SAP Application Support Lead specializing in Observability and Automation to join our team in Raritan, NJ. This role requires a strong technical foundation in SAP systems, hands-on experience with observability tools and automation frameworks, and the ability to lead support operations with strategic insight and managerial excellence. • Strong experience in SAP application support across modules (FI/CO, MM, SD, etc.). • Expertise in observability tools (e.g., Dynatrace, Splunk, SAP Focused Run, Grafana). • Hands-on experience with automation frameworks (e.g., Ansible, Python scripting, SAP Intelligent RPA). • Knowledge of SAP BTP (Business Technology Platform) and its integration capabilities. • Understanding of ITIL processes and incident/change management. Roles & Responsibilities • Lead SAP application support initiatives with a focus on observability, monitoring, and automation across landscapes. • Design and implement observability strategies using modern tools to ensure system health, performance, and proactive issue detection. • Drive automation of routine support tasks, incident resolution, and system checks to improve efficiency and reduce manual effort. • Collaborate with cross-functional teams to ensure seamless integration and support of SAP modules. • Provide leadership and mentorship to offshore and onshore support teams. • Develop and maintain dashboards, alerts, and reporting mechanisms for SAP system performance and reliability. • Ensure compliance with SLAs and support KPIs. • Participate in root cause analysis and continuous improvement initiatives. Generic Managerial Skills, If any • Proven ability to lead and manage global support teams. • Strong communication and stakeholder management skills. • Experience in planning, prioritizing, and delivering support services in a high-demand environment. • Ability to drive continuous improvement and innovation in support operations. Salary Range: $120,000 - $140,000 a Year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

The Quality Assurance Manager- leads a team of quality professionals that provide quality oversight, GMP guidance and support and make quality related decisions for the designated functional areas within the Sharp Commercial sites. Responsibilities include but are not limited to the supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports and make recommendations on resolutions and/or path forward for quality related issues. The Quality Assurance Manager is responsible for ensuring all customers receive the appropriate level of quality support and partnership. The QA Manager and their team will work closely with customers on a routine basis and the QA Manager will serve as the first level of escalation for all customer issues or concerns. The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality issues and documentation requirements could expose the company to significant risk or economic loss. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the QA Manager. Other duties may also be assigned: Directly supervise the work activities of employees engaged in quality related tasks on the floor to ensure that products and processes meet customers, company, and regulatory requirements/standards. Participate in internal, regulatory and customer audits at the discretion of management. Review and investigate nonconformances and complaints as needed. Create, review and revise SOPs on a designated basis to ensure accuracy. Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management. Effectively communicate a variety of personnel actions, e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime. Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls. Support training department to identify new opportunities for training program. Serve as the alternate for the Head of Quality during he/her absences. Summarize data, draw conclusions, and turn recommendations into clear communications to be distributed to all levels of the organization. Support the manufacturing team to ensure the compliance of processes and products and ensure testing and inspection meet all requirements. Track and monitor internal and customer KPIs related to quality control and implement programs designed to increase employee's awareness and knowledge of product nonconformities. Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the department. Identify and implement quality system improvements when gaps are identified through audits, investigations, and departmental reviews. Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Work with the team of training specialists to develop processes and best practices for building, managing, and continually improving GMP training program for new and existing staff according to cGMP's and in alignment with Sharp's Global Training Standard. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Direct supervision of quality professionals at the local site. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE: Bachelor's degree in science is preferred with five to seven years of related experience or Associate's degree with seven to ten years of related experience or a minimum of ten years' related experience. Knowledge of current FDA regulations and current industry practice. Thorough knowledge of quality and/or operations required. Knowledge of DEA regulations desired. Broad knowledge of current pharmaceutical industry including packaging practices. Above average written and oral communication skills required. Above average organizational and planning skills required. Knowledge of statistical concepts, methods, and software (knowledge of Minitab is a plus). Strong data gathering and analytical skills using statistical software. Strong root cause analysis skills, and the ability to apply rigorous structured problem-solving techniques. 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 functions. While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and 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. While performing the duties of this job, the employee is normally required to sit at a desk and routinely go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. DISCLAIMER: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Job DescriptionDescription: As a Quality Engineer you provide quality engineering support and expertise in all stages of the product life-cycle to ensure that Peregrine and DORC branded products meets specifications, issues are adequately and timely resolved, and quality of product, process and supplier quality shows continuous improvement. Location: This position is on-site at our New Britain, PA production facility. About the position Ensure that protocols, reports, and records created as part of product and process development as well as changes in products and processes are critically independently reviewed for content and compliance Drive and support continuous improvement across the organization by providing quality engineering expertise to improve robustness of design, process and supplied material Optimize, align, and control the inspection and measurements methods (including level of inspection) and acceptance criteria across the supply chain Support of the operations, engineering and purchasing department in case non-conforming materials are detected by owning the process of non-conforming products Implementation of immediate mitigation actions in case non-conforming materials are detected Coordinate and support root cause investigations Prevent reoccurrence of quality issues Monitoring progress in corrective action implementation Verify that corrections and corrective actions are effective Ensure documentation on NCs and SCARs is complete at closure Provide periodic reporting and trending. Ensure that suppliers used by DORC have the capabilities to meet DORC requirements and are selected, qualified, evaluated and maintained per internal procedures. Maintain relationship with and oversight on suppliers through periodic visits and execution of supplier audits. Drive efforts to increase the maturity of the internal organization as well as suppliers. Requirements: Skills, know-how and experience: Bachelor's degree (or equivalent ability) in relevant technical field required. Master's degree preferred. Minimum 3 years in quality engineering in a regulated environment Knowledge of mechanical, plastics and/or electrical parts and their manufacturing methods Understanding of quality system requirements (ISO9001, ISO13485 or similar) Relevant experience in quality engineering in product development, production, and/or supplier management Experience in conducting audits preferably against ISO13485 standard Experience in participating in and/or leading quality improvement projects Understanding of and experience with inspection and measurement methods and/or other concepts to assure quality of materials and product Understanding of the application of statistics in quality control Fluent English (written and spoken) Ability to work independently in a geographically separated multi-national and multi-functional team environment Collaborates effectively in international cross-functional teams Communicate actively with production engineers Open minded for improvement opportunities and change towards striving for best-in-class compliance performance High level of integrity and ethical standards What does Peregrine Surgical have to offer you? Peregrine Surgical, LLC is part of the Dutch Ophthalmic Research Center - a Zeiss Company; we value our employees and provide top tier benefits. You can expect the following: 3 weeks of vacation (accrued) 10 sick days annually (prorated for new hires) 10 US holidays 90% of Health Insurance premiums paid by the company. Dental & Vision coverage 401k plan with company match Paid short term, long term & basic life insurance paid by the company. Bonus program Did you know ...? DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery. DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities... Will you be our new Quality Assurance Engineer? Are you up for this? Then apply today! Do you still have questions? Then contact Monique Christy, Human Resources: ************************. Carl Zeiss Meditec USA, Inc and its subsidiaries provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs. Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Review and approve manufacturing procedures. Support regulatory inspections and audits by ensuring inspection readiness within facility. Perform internal housekeeping audits. Perform analysis on quality indicating data and identifying trends. Provide oversight for trending of quality compliance metrics. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #Li-BG1 #Li-Onsite The anticipated base pay range is$81,273-$106,669 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Business: Critical Care Department: Quality Assurance Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements. Provide proper control, review, and management of site documentation to ensure GMP and regulatory compliance. Key Stakeholders: Internal Quality Assurance Team, Site Management, All Departments Key Stakeholders: External FDA or other health organizations Reporting Structure Directly reports to Quality Assurance Supervisor Essential Duties and Responsibilities * Responsible for the review, approval, and disposition of finished product for the site and final CoA signature * Facilitates client project management as required ensuring "quality on time and in full" * Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed * Leads or participates in focused deviation cross-functional investigations, improvement projects * Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified * Provides assistance to other QA associates and assist with department trainings * Provides support to QA management during regulatory audits * Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs * Performs internal audits and assist in writing reports for audits * Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases * Maintain the vendor complaint process * Maintain, monitor and provide trend analysis of DIs, LIs, CAPAs, customer complaints and change controls * Performs special projects and/or assignments as indicated by Quality Management * Oversee and review of Obsolete material destruction * Perform Quality inspections on packaging line as needed * Maintain supplier approval program * Support/Maintain site Document Control System * Review, approve and close out Document Change Requests * Tracking of changes using DCC spreadsheet and supporting actions through closure * Maintain original documentation archive and Archival of documents offsite * Printing of new and revised documents, Issuance of forms, logbooks * Review documentation submitted for routing in eDMS for proper formatting and accuracy. * Load documents into an electronic Documentation Management System (eDMS) * Route documents for approval in the eDMS * Recall documentation for audits in a timely manner * Performs external audits and assist in writing reports for audits * Responsible for maintenance and revision procedures related to document control * May require up to 25% travel. Key Competencies (knowledge, skills, and abilities every person must possess to be successful) * Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems * Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers * Excellent verbal and written communication skills * Energetic, enthusiastic, and motivated disposition * Attention to detail with strong organizational skills * Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner * Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports * The ability to drive projects in relation to implementation of new workflows and updates to new systems Education / Experience * Bachelor's degree in relevant scientific quality assurance / technical field * 5+ years of experience * Strong understanding of pharmaceutical cGMP, industry standards, and regulations * Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels * Expert level user for Quality computer systems * Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems * Thorough understanding of computer system validation and GAMP requirements

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as “There is a Patient Waiting.” Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters. Discover Impactful Work: Our company is seeking a Quality Engineer responsible for quality approval for equipment validations (IQ,OQ,PQ), risk assessments (FMEA), alarm management (temperature, humidity, differential pressure), and oversite of Maximo work order system (calibration, corrective maintenance).This role requires the ability to make decisions that are based on sound quality/compliance principles and appropriate GMP Regulations. A Day in the Life: Apply Good Manufacturing Principles in all areas of responsibility. Demonstrate and promotes the company vision. Review impact analysis of changes to facilities and equipment. Review and Approve GMP documents to ensure compliance with all applicable internal and regulatory standards. Advises management of issues identified during qualification activities and recommends appropriate actions to address the issue(s). Drives continuous improvement to the site's equipment and facilities qualification/validation program. Ensure Compliance to the site calibration program. Supervise the preventative maintenance program. Facilitate, participate, and approve Risk Assessment. Conduct all activities in a safe and efficient manner. Other duties may be assigned to meet business/compliance needs. Keys to Success:Education Bachelors degree engineering or science fields is required. Experience 4-5 years in Qualification and Validation in pharma, or medical device environment required. A minimum of 2 years in the pharmaceutical/related regulated industry. Experience with process validation in Quality Systems. Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems. Experience in Risk Assessment! Knowledge, Skills, Abilities Must be detail oriented to detect errors or deficiencies in validation and qualification documentation and requirements of the system Utmost integrity and personal responsibility are required to maintain the for regulatory compliance. Good written and verbal and communication skills. Detailed understanding of regulatory documentation requirements. Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products. Ability to work independently. Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems. Proficiency in skills required to read, understand, and enforce to the SOPs and policies of a GMP environment. Physical Requirements This position is administrative and is positioned in an office environment but does require some time in manufacturing, packaging, and computer areas. It requires standing bending reaching, walking and talking as well as exerting up to 20lbs. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Cleveland Steel Container, an Employee Owned and World Class Steel Pail Manufacturing company, is seeking an enthusiastic, responsible, and customer-oriented individual that has a positive attitude and shares the values of our company culture, which is built around teamwork, family, honest communication and producing desirable results for our Quakertown, PA manufacturing facility. INDUSTRY LEADING BENEFIT PROGRAM THAT INCLUDES LOW EMPLOYEE PREMIUMS FOR MEDICAL INSURANCE, UNMATCHED RETIREMENT PROGRAMS AS AN EMPLOYEE OWNER. DENTAL, VISION, LIFE AND DISABILITY INSURANCES. NEW EMPLOYEES ARE ELIGIBLE FOR 15 DAYS OF PAID VACATION PER CALENDAR YEAR AND 11 PAID COMPANY HOLIDAYS. SIGN ON BONUS OF $2,000 PAID OUT IN FIVE INSTALLMENTS OVER THE COURSE OF ONE YEAR. $1,000 REFERRAL BONUS FOR ANYONE THAT IS REFERRED THAT GETS HIRED BY THE COMPANY This Quality Assurance Technician position is responsible to ensure company and customer quality standards are being achieved. Duties and Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed. Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures. Conduct and complete Internal Quality audits and may be involved in the development of testing methods Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Cleveland Steel Container was founded in 1963 to provide customers with a dependable steel pail. Currently, we have four pail plants located strategically throughout the United States to support our customers. At our Streetsboro facility, we have a metal stamping plant to provide component parts for our pails. Our goal is to continuously provide our customers with quality pails through excellent service at an outstanding value. Finally, we make good pails and deliver them on time! Cleveland Steel Container offers a competitive salary based on commensurate experience and a comprehensive benefits program that includes medical, dental, and vision insurance, flexible spending accounts, 401k with company contribution, profit sharing, paid holidays and vacations, life insurance and short & long-term disability coverages along with an Employee Stock Ownership Plan (ESOP).

Vantage Labs is a world leader and innovator in the development and leveraging of artificial intelligence and natural language technologies into a broad spectrum of vertical markets and industries. We specialize in providing advanced Software-as-a-Service solutions; we believe our customers should be able to choose top-quality linguistic solutions that meet the challenges of their market and business. Our technology is built on more than 30 years of linguistic research and is integrated with both SaaS and installable products. Vantage's technologies are deployed in many common products, and we own some of the most prevalent technology patents in the country. Summary: Vantage is seeking a skilled and experienced Quality Assurance Analyst to join our core application development team in New Hope, PA. You will conduct tests, analyze the results, and report observations to the design team. Additionally, contribute to the technical testing discussions of the team while working with the developers to share the perspective of testing from a tester/end user point of view. Responsibilities: Develop and execute test scripts for product enhancements; execute regression tests and cross for revised applications; maintain records of all application testing; prepare reports summarizing testing results. Develop manual and automated test cases associated with application projects. Excellent oral and written communication skills to effectively communicate the status/progress of testing. Be a team player. Ability to meet deadlines. (Agile Environment, 2 week sprints) Miscellaneous duties, as assigned. Qualifications: Bachelor's Degree is required. QA Experience with Internet/Web-based software. Prior experience with Quality Assurance testing software including Manual test and automated functional testing. Experience writing and executing test plans and scripts from product specifications and use-cases. Understanding of software QA methodologies, practices, and processes. Knowledge of standard web technologies, including app servers, web servers, relational databases, browsers, etc. Experience with defining / tracking bugs and regression testing. Benefits & Perks: Medical, Dental, and Vision Insurance 401(k) Life Insurance Short-Term and Long-Term Disability Legal and ID Theft Protection Pet Insurance Accident Insurance Critical Illness Insurance Tuition Reimbursement and paid training Equal opportunity employment There's one more, very important thing. We are an equal opportunity employer. We search for amazing people of diverse backgrounds, experiences, abilities, and perspectives. We take care of each other to create an inclusive work environment where we love to come to work every day. We'd be happy to provide reasonable accommodations to help you apply. We hope you can join us.

Full-time Description The Quality Assurance Manager (QA) will be responsible for both leadership and hands on activities involving quality assurance, establishing, and validating specifications, customer complaint resolution and compliance with ISO9001 standards. As a leader in the organization, the QA Manager will be instrumental in the updates and implementation of policies and procedures to ensure that quality and regulatory standards are met. The successful candidate will plan, coordinate, and direct quality management system to comply with the ISO9001 standards. The successful candidate must have experience in managing an ISO certified quality system and has led successful recertification audits. The candidate will be the primary contact for customers on issues regarding new product inquiries and specifications, process parameters, test methods and compliance. Successful use of a structure root cause problem solving methodology is required and will be validated during the interview process. This is more than an administrative role; this is a leader who must have solid knowledge of plastic extrusion processing/compounding and product testing. A knowledge of other plastic processing such as injection molding and compression molding a plus. The QA Manager will report to the Director of Operations and will have accountability for the plant testing lab. A candidate who has experience in EH&S Management will receive additional consideration. Requirements Position Description: · Managing, auditing, and maintaining all aspects of ISO 9001; QMS program and implementation · Maintain appropriate ISO certification requirements and coordinate registration activities as management representative · Developing and maintaining the root cause and countermeasure process · Creating quality documentation, quality assurance reports and processes · Set standards for good relations and communications with customers and regulatory agencies · Reviewing products, processes, and systems on an ongoing basis to determine potential improvements to the QMS Required Skills & Competencies: · ISO Standards · Quality procedures and practices · Proficient in technical writing · Ability to communicate with customers · Leadership skills · Manufacturing processes and quality controls · Industries: Compounding, Injection Molding · Bachelor's degree Mechanical Engineering, Industrial Engineering

Key Responsibilities: * Confirm that all manufactured items are in conformance with all customer specifications. * Work together with manufacturing, engineering, and shipping departments to maximize throughput and effectiveness. * Maintain all logs and reporting supporting the ISO9001 QMS. * Deal with customers as required to resolve issues as they arise. * Prioritize work as it arrives at Inspection and assign necessary resources to complete inspection. * Deal with vendors as required to resolve issues. * Handle all paperwork promptly (RMAs, FAIRs, Corrective Actions, SCARs, etc.) Must be strong to expert at the following: * using all common measuring devices, calipers, micrometers, gages, CMM * using all common business software, Outlook, Excel, Word This is a key position at this company. This is a full time, permanent, day shift position in a growing company. This position reports directly to the President. Benefits. Vacation. 401k with match. Compucraft Fabricators Inc. Montgomeryville PA 18936.

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: * Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience * Or * Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience * 3 years' experience in QA auditing involvement. Preferred: * Experience with leading a project. Major Duties and Responsibilities: * Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. * Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. * Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. * Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. * Participates in Continuous Quality Improvement efforts. * Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. * Participate in updates to the audit matrix and/or design and scheduling of internal audits. * Reviews proficiency data prior to submission. * Reviews and grades proficiency survey results and issues reports for management review. * Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. * Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. * Remains current in compliance trends for those areas of responsibility. * Participates/presents in laboratory continuing education program as needed. * Ensure that pertinent information is entered into and maintained in the appropriate QA files. * Assists QA Regulatory with external audits/inspections, as applicable. * Other duties as assigned. Knowledge, Skills, and Abilities: * Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. * Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. * Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. * Ability to identify operationally efficient strategies to adhere to quality compliance requirements. * Ability to effectively present information and respond to questions from all co-workers. * Ability to effectively prioritize assignments to meet long and short-term deadlines. * Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. * Possess good computer skills (to include Excel and Word) and internet usage. * Ability to travel, including out of state. * Maintains regular and reliable attendance. Physical Demands: * Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. * Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

Title: ICQA Associate Hours/Shift: 1st Shift Mon - Fri 8:00 am - 4:30 pm at $20.25hr or 2nd Shift Sat - Wed 3:00pm to 11:30pm at $21.25hr If you're looking to be at the forefront of disrupting the ecommerce industry, wanting to make your mark and be continuously challenged to grow, your time has come. ShipBob is recognized as #1 on Crain's 2020 "Fast 50" list of the fastest-growing companies in Chicago & Inc.5000 top 500 companies with the most proven track records. With this growth, we are looking for top talent to help us reach the next level. Role Description: This is an incredibly important position that helps to monitor inventory activities of all clients at each fulfillment center while allowing all existing operations team members to remain focused on their day-to-day responsibilities. As ShipBob continues to grow, it is imperative to provide a great experience in serving our clients' needs while maintaining sustainable growth and scalability from an operations perspective. About Us: ShipBob is a cloud based logistics platform that partners with over 5,200+ e-commerce businesses to help them be more successful online. We offer a full suite of fulfillment solutions for our merchants, including the ability to improve their transit times, shipping costs and deliver best in class experience to their customers. With almost 100% accuracy rate in fulfilling orders and orders shipped on time, our merchants can count on us to deliver excellent service. ShipBob's growing fulfillment network is powered by our proprietary technology and acts as a back office for logistics, providing merchants with full visibility into orders, inventory levels in real time, and access to advanced analytics, over 27 integrations and data reporting. As one of the fastest growing tech companies in Chicago with over $330M+ raised from blue-chip investors like Menlo Ventures, Bain Capital Ventures, Hyde Park Venture Partners and SoftBank Vision Fund 2, our goal is to continue to be the #1 best fulfillment technology in the industry. To help us meet this standard, we are scaling our entire team and looking for people who share our core values and have an entrepreneurial mindset About You: At ShipBob, we're looking for individuals who embody our core values: * Be Mission-Driven. We want team members that are passionate about helping entrepreneurs improve their business, and bring that passion every day. * Be Humble. We have ambitious goals, and our team members understand that success or failure depends on us working together and leaving egos at the door. * Be Resilient. Logistics is a complicated business. So is software. We value team members that never give up and keep iterating until a problem is solved. * Be a Creative Problem Solver. As a startup, we value smart, innovative solutions to complex problems. We fall in love with the problem, not our "favorite" solution. * Be Safety Minded. It's not just talk; it's the way you work. What You'll Do: * Investigate inventory discrepancies reported by the Operations team. * Perform physical inventory cycle counts, and reconcile inventory variances. * Communicate updates and relay important operational information about clients directly to ICQA Lead. * Play a pivotal role in understanding the root cause of inventory adjustments and participate in efforts to correct. * Vocalize concerns around inventory practices to ICQA Lead, helping to identify areas of opportunity in day to day processes. Expectations: * Proficient in cycle counting and inventory control processes according to written SOP's. * Perform Root Cause Analysis around inventory discrepancies and review findings with ICQA Lead. * Ensure inventory variances are researched and resolved in a timely manner, allowing fulfillment of outbound orders. * Ensure timely communications to MC team for any orders not able to be fulfilled due inventory discrepancies. What You'll Bring To The Table: * Demonstrates the ability to quickly adapt to changing conditions and solve problems immediately. * Ability to determine inventory discrepancies, perform physical inventory cycle counts, and reconcile inventory variances. * Possesses effective written and verbal communication skills; displays reading comprehension skills. * Displays the ability to multitask and handle multiple issues at the same time without stress. * Displays attention to details. * Ability to lift 40lbs without any health limitations. * Able to stand and walk continuously during and up to an 8-10hr shift. * Able to bend, stoop, reach above, and push/pull frequently. * May be required to flex into other departments for support as needed. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Perks and Benefits: * Medical, Dental, Vision & Basic Life Insurance * 401K Match * Variety of voluntary benefits, such as: short term disability * Weekly paychecks & Wage Progression Program * KinderBob Daycare Stipend program * Paid Time Off & Sick Time Off * Referral Bonus Program * Fun Culture >>> Check us out on Instagram Reports to: ICQA Area Manager Classification: Hourly/Non-Exempt ShipBob provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. 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.

Meet REVOLVE: REVOLVE is the next-generation fashion retailer for Millennial and Generation Z consumers. As a trusted, premium lifestyle brand, and a go-to online source for discovery and inspiration, we deliver an engaging customer experience from a vast yet curated offering totaling over 45,000 apparel, footwear, accessories and beauty styles. Our dynamic platform connects a deeply engaged community of millions of consumers, thousands of global fashion influencers, and more than 500 emerging, established and owned brands. Through 16 years of continued investment in technology, data analytics, and innovative marketing and merchandising strategies, we have built a powerful platform and brand that we believe is connecting with the next generation of consumers and is redefining fashion retail for the 21st century. For more information please visit **************** At REVOLVE the most successful team members have a thirst and the creativity to make this the top e-commerce brand in the world. With a team of 1,000+ based out of Cerritos, California we are a dynamic bunch that are motivated by getting the company to the next level. It's our goal to hire high-energy, diverse, bright, creative, and flexible individuals who thrive in a fast-paced work environment. In return, we promise to keep REVOLVE a company where inspired people will always thrive. To take a behind the scenes look at the REVOLVE “corporate” lifestyle check out our Instagram @REVOLVEcareers or #lifeatrevolve. Are you ready to set the standard for Premium apparel? Main purpose of the Quality Assurance Associate role: Minimize monetary loss of defective merchandise by identifying the most effective defect recovery process for each item. Major Responsibilities: Essential Duties and Responsibilities include the following. Other duties may be assigned. Minimize monetary loss of defective merchandise including apparel, shoes, accessories and beauty Identify the most effective defect recovery process for each item - RA, Restore, Sellable Defect, Other Identify defects by inspecting defective merchandise of apparel and non-apparel items Clearly communicate with vendors regarding defective and unacceptable merchandise Aggressively negotiate credit or replacement merchandise for defects with vendors Establish and maintain rapport with vendors through positive and consistent communications Assist in other areas in department as needed Required Competencies: To perform the job successfully, an individual should demonstrate the following competencies: High level of attention to detail and the ability to identify apparel and non-apparel flaws Hands-on approach at restoring merchandise quickly and efficiently Apparel construction and fabrication knowledge Strong communications, prioritizing, and organizational skills Ability to take ownership of assigned tasks and meet responsibilities without supervision Ability to work successfully with any personality type and be a team player Sense of urgency and ability to maintain performance quality under pressure Minimum Qualifications: Experience working in a QA/QC, Production or Warehouse environment required Computer literate in Excel, Word and Email required Proficient in English Technical fashion, garment construction or fabrication knowledge preferred Physically capable to stand and walk for entirety of shift Work Environment: While performing the duties of this job, the employee is occasionally exposed to extreme cold and extreme heat. The noise level in the work environment is usually moderate. ATTENTION: After submitting your application, please check your spam folder for emails on your application status. Emails are sent from an ADP email address. The following job description contains representative examples of work that will be performed in positions allocated to this classification. It is not required that any position perform all of the duties listed, so long as primary responsibilities are consistent with the work as described. Roles and responsibilities can often be expanded to accommodate changing business conditions and goals, as well as to tap into the skills and talents of the individuals in the company. Accordingly, associates may be asked to perform duties that are outside the specific functions that are listed.

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience Or Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience 3 years' experience in QA auditing involvement. Preferred: Experience with leading a project. Major Duties and Responsibilities: Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. Participates in Continuous Quality Improvement efforts. Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. Participate in updates to the audit matrix and/or design and scheduling of internal audits. Reviews proficiency data prior to submission. Reviews and grades proficiency survey results and issues reports for management review. Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. Remains current in compliance trends for those areas of responsibility. Participates/presents in laboratory continuing education program as needed. Ensure that pertinent information is entered into and maintained in the appropriate QA files. Assists QA Regulatory with external audits/inspections, as applicable. Other duties as assigned. Knowledge, Skills, and Abilities: Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. Ability to identify operationally efficient strategies to adhere to quality compliance requirements. Ability to effectively present information and respond to questions from all co-workers. Ability to effectively prioritize assignments to meet long and short-term deadlines. Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. Possess good computer skills (to include Excel and Word) and internet usage. Ability to travel, including out of state. Maintains regular and reliable attendance. Physical Demands: Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

Job Details Warminster, PA Full Time 4 Year Degree $55000.00 - $55000.00 Salary/year Up to 50% Description Join us at Delta Community Supports, Inc. (“Delta”), where every day brings the opportunity to make a difference in the lives of others! As a leading provider of support services for individuals with intellectual and developmental disabilities, we're on a mission to empower and enrich the lives of those we serve. Are you passionate about fostering independence, promoting inclusion, and creating meaningful connections? If so, come be a part of our dynamic team where innovation, compassion, and dedication drive our every endeavor. Embark on a rewarding career journey with Delta Community Supports, Inc., and help us shape a brighter future for all! Delta Community Supports, Inc. is seeking a Quality Assurance Coordinator to support our Quality Assurance department in upholding Delta's mission of delivering high-quality services to the individuals we serve. The Quality Assurance Coordinator will be responsible for monitoring the operational integrity of our residential and vocational programs. Acting as a key liaison between the local and national offices, this role ensures that all programs operate in full compliance with applicable state regulations, agency policies, and procedural standards. The Coordinator will play a critical role in evaluating program performance, driving continuous improvement, and ensuring consistent implementation of best practices across all service areas. Requirements: Proven ability to build collaborative relationships with individuals from diverse cultural, socioeconomic, and educational backgrounds. Strong commitment to diversity, equity, and inclusion. Excellent organizational, time management, and multitasking abilities with a capacity to meet deadlines under pressure. Effective interpersonal skills to support individual growth and team development. Solid understanding of supervisory and administrative practices. Strong verbal and written communication skills; proficiency in English and basic arithmetic. Technologically proficient, including Microsoft Office and the ability to adapt to new tools. Capable of operating standard office equipment and vehicles, with a valid driver's license and compliance with applicable regulations. Qualifications Bachelor's degree from an accredited college or university. Associates degree or sixty (60) credit hours from an accredited university or college and four (4) years' experience working with persons with intellectual disabilities may be substituted for Bachelor's degree. Two (2) years' work experience working directly with persons with intellectual disabilities Two (2) years' work experience using electronic health records and database management. Valid driver's license in the state of residence with a satisfactory driving record. Commitment to and knowledge of community-based support for persons with disabilities Working knowledge of management of an effective Quality assurance program Ability to present facts and recommendations effectively in oral and written form Independent judgment is required to plan, prioritize, and organize diversified workload Knowledge and understanding of local regulatory agency operations Benefits: 401 (k) Match program, with a generous match of 3%. Comprehensive healthcare coverage, including medical, dental, and vision insurance plans. Company-paid life Insurance coverage for full-time employees Voluntary supplemental Insurance options for additional coverage. Company paid holidays, sick time, and vacation time. Employee Assistance Program (EAP) provides eligible employees with confidential counseling, support services, and resources to enhance well-being and maintain work-life balance. Professional development and internal advancement opportunities. Please note that participation in the listed benefits is contingent upon eligibility criteria.. Please Visit Our Website to complete an Online Application at **************** EOE M/F/D/V

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates the quality mindset to strive for excellence, continuous improvement and ethical conduct in attaining and maintaining the highest levels of quality. Key Responsibilities Ensure the timely completion of high-quality robust investigations with appropriate root cause(s). Ensure appropriate Corrective and Preventative Actions (CAPA's) are developed and implemented. Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release. Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed. Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs. Collaborate with site personnel to provide guidance and determine resolution for end-to-end manufacturing issues. Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Perform analysis on quality indicating data and identifying trends. Contribute to maintain investigation compliance metrics. Support investigation process improvement initiatives. Job duties performed may require exposure to and handling of biological materials and hazardous chemicals. Able to work independently and also in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 2-4 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Excellent organizational skills with the ability to simplify and clearly communicate complex concepts. Excellent verbal, written and presentation capabilities. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #Li-BG1 #Li-Hybrid The anticipated base pay range is$61,454-$80,656 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 2nd Shift Key Responsibilities * Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. * Support manufacturing activities for cGMP compliance through spot checks/internal audits. * Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. * Review of all documentation, in accordance with Good Documentation Practices (GDP). * Review, revise, or draft Standard Operating Procedures (SOPs) * Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. * Support batch review & material release in SAP for In-house reagents. * Support Floor Spot-check, audit trail review. * Strive to reduce non-conformances in supported areas by proactively driving compliance. * Support Investigations team by providing quality and compliance input for continuous improvement and remediations. * Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. * Utilize multiple electronic quality systems, batch records and SAP. * Work in a team based, cross-functional environment to complete tasks required to meet business objectives. * Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. * Provide QA shop floor support for extended periods of time. * Responsibilities will include but not limited to tasks mentioned above. * Support regulatory inspections and audits as needed. * Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. * Other duties will be assigned, as the need arises. * Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. * Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses * Color Perception both eyes 5 slides out of 8. * Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements * Bachelors degree required in Life Sciences or Engineering. * 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience * Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. * Experience with quality support in clinical manufacture is preferred. * Flexible to work on weekends, as needed. * Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. * Is frequently required to communicate with coworkers. * While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. * Ability to lift 20 lbs. * Report to work on-time. * Duties are required to be performed on-site at manufacturing facility. * Perform other duties as assigned. * Attend departmental and other scheduled meetings. * Practice good interpersonal and communication skills. * Demonstrate positive team-oriented approach in the daily execution of procedures. * Promote and work within a team environment. * Learn new skills, procedures and processes as assigned by management and continue to develop professionally. * Support and contributes to projects. * Assist in troubleshooting issues related to manufacturing. * Technical knowledge within functional units * Demonstrate an understanding of the process in order to properly perform the assigned tasks. * Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. * Utilizes tools within MS Office and other systems to improve business effectiveness. * Read and interpret documents such as safety rules, operating instructions, and logbooks. * Review and provide feedback for SOPs. * Interpret a variety of instructions furnished in written, oral, or diagram. * Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. * Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. * Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, * Aseptic processing in ISO 5 clean room and biosafety cabinets. * Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. * Great attention to detail and ability to follow the procedures. * The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. * Good written and verbal communication skills are required. * Ability to summarize and present results, and experience with team-based collaborations is a must. * Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. * Ability to collaborate well with stakeholders, customers and peers. * Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. * Must be able to discern the criticality of issues and to communicate to management regarding complex issues. * Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The anticipated base pay range is $75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.