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Quality assurance engineer jobs in Allentown, PA

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  • Engineer III, QA

    Invitrogen Holdings

    Quality assurance engineer job in Allentown, PA

    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.
    $68k-91k yearly est. Auto-Apply 16d ago
  • Test Req - Do Not Apply WH

    Maximus, Inc. 4.3company rating

    Quality assurance engineer job in Bowers, PA

    Description & Requirements Test for qq Essential Duties and Responsibilities: * Assess current environment and develop a 3-5 year HR technology strategy, objectives, and roadmap. * Lead the implementation of process improvement and innovative tools. * Partner with HR functions to assist in the adoption of efficient, scalable end-to-end processes. * Ensure HRIS staff are trained in process improvement techniques. * Partner with IT to identify and articulate system needs, vendor selection, implementation, upgrade, integration, and maintenance of systems. * Lead project planning teams related to major upgrades and system implementations. * Collaborate with HR business partners to understand business needs related to human resources information. * Provide consultation and analyses to enhance human resources decision making. * Collaborate with IT and legal to ensure the secure storage and movement of human resources information to systems within and outside of Maximus. * Develop test plans as needed and oversee successful completion of test phase to move to production. * Work closely with vendors and staff to design and test integrations. * Lead implementation of processes to ensure data integrity. * Manage HRIS budget. * Lead cross-functional planning and execution of projects aligned with the HR strategy and including, process design, functional requirements, data management, testing, and production operations and support design. * Manage staff to achieve HR strategic goals and objectives that require systems and technology related support. * Provide functional production support, system configuration and product /data stewardship for the suite of HR tools, and the design and management of inbound and outbound HR data interfaces. * Coordinate multiple HRIS solutions within a heavily matrixed organizational environment. * Liaise with divisional and corporate IT departments in coordinating IT projects, IT standard procedures, initiatives, Help Desk changes, and system outages. * Support and partner with HR team to define and implement HR processes and procedures that leverage technological capabilities for the collection, maintenance and reporting of data. * Oversee system upgrades, system interfaces, data quality/integrity, HR Division web applications. Minimum Requirements: * Bachelor's degree. * 12-15 years experience. to send to WD Minimum Requirements Minimum Requirements: * Bachelor's degree. * 12-15 years experience. to send to WD EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at applicantaccommodations@maximus.com.
    $58k-107k yearly est. 21d ago
  • TEST PA004 - Montgomery Mall General Application

    Christian Brothers Automotive 3.4company rating

    Quality assurance engineer job in North Wales, PA

    Christian Brothers Automotive Our mission is simple: To create an uncommonly great experience for customers in need of auto service and repair. Christian Brothers Automotive was founded in 1982 on the principles of honesty and integrity. These principles have taken our organization to over 300+ locations all across the country. We strive for excellence in service as the #1 Automotive Repair Franchise in the country. We have a great culture, a great mission, and a great time. We hope you'll consider joining us! The job description will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Qualifications The qualifications will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Additional Information All of your information will be kept confidential according to EEO guidelines. Christian Brothers Automotive is an Equal Opportunity Employer.
    $84k-111k yearly est. 60d+ ago
  • Senior Quality Assurance Compliance Specialist

    Piramal Enterprises Ltd.

    Quality assurance engineer job in Bethlehem, PA

    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
    $75k-99k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Assistant (Manufacturing Plant) ~ $2,000 Sign On Bonus

    Cleveland Steel Container Career 3.8company rating

    Quality assurance engineer job in Quakertown, PA

    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).
    $42k-91k yearly est. 60d+ ago
  • Quality Assurance Assistant

    SST Direct 4.2company rating

    Quality assurance engineer job in Allentown, PA

    Job DescriptionDIRECT 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 Powered by JazzHR UUi6om7PUD
    $19-23 hourly 9d ago
  • QA Clinical Supplies Specialist

    ZP Group 4.0company rating

    Quality assurance engineer job in Lansdale, PA

    Piper Companies is seeking a QA Clinical Supplies Specialist to join a major pharmaceutical manufacturing company located in Lansdale, PA. This is a Hybrid role. The QA Clinical Supplies Specialist will ensure the quality, compliance and integrity of clinical trial supplies. Responsibilities of the QA Clinical Supplies Specialist include: * Ensure clinical supply materials meet company policies and regulatory standards. * Lead projects aimed at improving process performance, including yield improvement, cost reduction, and cycle time reduction. * Assist in coordinating significant quality events, including fact-finding and investigation support. Qualifications for the QA Clinical Supplies Specialist include: * At least 2 years of experience in the Pharmaceutical or a related industry, specifically in a Good Manufacturing Practice (GMP) field such as Technical, Engineering, Quality, or Operations * Familiarity with batch disposition activities and Good Manufacturing Practices (GMP). * Excellent problem-solving, communication, and collaboration skills. * Basic understanding of Microsoft applications (Excel, Outlook, Access) and knowledge of ERP/MES, Trackwise, and SAP systems. * Bachelor's degree in a related field. Compensation for the QA Clinical Supplies Specialist include: * Salary Range: $40-45/hr. * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave if required by law, and Holidays This job opens for applications on 3/21/2025. Applications for this job will be accepted for at least 30 days from the posting date. * Keywords: Quality Assurance, QA, pharma, problem-solving, GMP, good manufacturing practices, collaboration, batch disposition, operations, regulatory standards, projects, clinical, Process Improvement, analytical testing, training and development, change control, quality management systems, validation and qualification, documentation, risk assessment, inspection, batch records, quality control #LI-KT1 #LI-HYBRID
    $40-45 hourly 51d ago
  • QA Validation Specialist III

    Legend Biotech 4.1company rating

    Quality assurance engineer job in Raritan, NJ

    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 Validation Specialist III as part of the Quality team based in Raritan, NJ. Role Overview The QA Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity. Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site Review and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration) Provide expertise and solutions to issues regarding qualification and validation strategies and documentation Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems. Assist in the development of validation and qualification related policies, procedures, templates, forms. Provides quality oversight on data integrity of systems, instruments, and equipment used at the site. Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations. Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous improvement Other duties may be assigned, as necessary. Requirements 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 GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus. Strong knowledge of GxP compliance. Experience in cGMP regulatory body audits. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Experience reviewing/auditing GMP documentation. Strong proficiency with using Microsoft Office applications. #Li-BZ1 #Li-Onsite The anticipated base pay range is$93,463-$122,670 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.
    $93.5k-122.7k yearly Auto-Apply 4d ago
  • Software Development Engineer - (Embedded & Firmware) - Full Time, Permanent Role,

    Midatlantic Employers' Association

    Quality assurance engineer job in Ancient Oaks, PA

    Job Description Software Development Engineer / Coding & Implementation (Embedded & Firmware) (Creating Software Solutions for Advanced Micro-Controller Based Systems for High Quality Manufactured Products) Full Time, Permanent Opportunity, "On-site role" Oaks, PA We are seeking an experienced Software Development Engineer who is knowledgeable with the principles of Embedded//Firmware methodologies to join our Team. You would play a critical role in the development of modern technology, enabling devices to perform specific tasks efficiently and reliably. Your work is integral to the functionality of countless products we manufacture for use by our clients. Your experience must include knowledge of the Full Product Lifecycle with Embedded Electronics, from beginning to end (inclusive of testing) within a Manufacturing organization. Experience and a comfort-level with working with High Voltage circuitry, plus HV Safe handling protocols is also needed. We offer a great working culture which includes working with Small Project Management Teams within a company who truly cares about their employees. Also needed is, someone who is experienced with working with various internal and external customers, such as: Product Managers, Sales, and with Management regarding strategic planning. We ask that you have Test & Measurement Instrument Design experience and that your skill set includes Software Architecture Design, Software Analyss and Code Development. An overall view of some of the skills needed: SW Architecture Design Software Analysis Code Development Finding Solutions to difficult SW issues C, C++, C#, Linux OO Programming Git/Jira Free RTOS QT BSP SQLife, SQL Server Lean and Agile skills for Product Development RDBMS Test & Measurement Instrument Design experience. General Position Overview: Under direction from the Software Development Team Supervisor, the Software Development Engineer is responsible for contributing a variety of embedded software and firmware design tasks. In this role the SWD Engineer will work as an individual contributor or as a member of a small team delivering software and firmware designs to meet or exceed defined product requirements. This position requires an individual with expert level skills in software architecture design, software analysis, and code development skills for embedded systems. Through collaboration with firmware, hardware, and other support design team members, the person in this position develops leading-edge software solutions for advanced microcontroller-based systems. This position works within a multi-disciplined, collaborative engineering organization to realize high quality manufactured products. Essential Job Responsibilities: Take lead role in the design, coding, integration and unit testing of new software/firmware systems as well as analyzing and modifying software/firmware applications written by others. Lead the definition of software/firmware system architectures, protocol definitions, APIs, third party library code options, design specifications and software/product test plans. Perform design feasibility studies and submission of work effort estimates for software development tasks associated with new product proposals. Identify, set up and document software development environments. Coordinate with manufacturing engineering to provide product programming solutions and released code. Perform research for and/or creation/initiation of product Engineering Change requests. Lead and/or participate in software development process engineering refinements. Perform assigned development group tasks in a high-quality fashion in accordance with all facility quality, safety, reliability, and compliance policies. Respect for High Voltage (HV) circuits. Ability to define and/or adhere to HV Safe Handling practices. Other miscellaneous duties as assigned. Communications Skills: Clear and concise, essential and clear communications tailored to "each" audience (fellow engineers, Product Managers, etc.) Interpersonal skills: Professional, respectful, helpful, sincere, positive and energetic persona. Listening skills: Ability to hear and meet the needs of Product Managers & Customers. Ability to pose questions for additional clarity when needed. Problem-solving skills: Advanced problem-solving skills in product S/W-F/W development methods and hardware integration. External Contacts Interaction: Is Limited and includes: Sales & Customer Contacts TSG personnel / Technology Partners Test Labs / Tech Support & APP Engineering Travel Requirements: 0 to 10% We cannot offer any type of Visa Sponsorship at this time. Bachelor of Science Degree CS or CE. EE and applicable S/W design experience may substitute. Eight (8+) years' work experience covering the full product lifecycle with an embedded electronics product manufacturing company. Expert-level programming skills in C, C++ & C#. Demonstrated expertise in object-oriented programming. Experience with version control and issue tracking software (Git/Jira preferred). Proven track record of microcontroller software development across multiple processor families with varying feature sets. Experience developing in embedded real-time multitasking operating systems (FreeRTOS preferred). Experience developing concurrent multitasking/multithreaded software systems. Demonstrated experience with various communication protocols, both point to point and network related. Ability to work independently and to prioritize multiple tasks and meet deadlines. Demonstrated capability in reading and understanding schematics and data sheets, coupled with possessing strong analytical, integration, support, and debugging skills. Simple and succinct verbal and written communication skills in support of communicating or creating design, integration, test and manufacturing documentation. Self-motivated, meticulous, and demonstrated problem-solving capability. Additional Soft/Hard Skillsets for our Product Manufacturing environment: Equal skill working effectively independently, within small teams, or as a team leader. Pragmatic experience with the cybersecurity concepts and methods (digital signatures, secure tokens, secure bootloader) Previous design experience with embedded Linux. Experience / knowledge of QT or other cross platform UI libraries. Advanced object-oriented design techniques (Design Patterns familiarity) Experience with Board Support Package (BSP) development / support. RDBMS development / maintenance experience (SQLite, SQL Server) Knowledge and experience in implementing solutions using digital signal processing techniques. Familiarity with test driven development techniques (unit testing, mocks/stubs, etc.). Use of Lean and Agile techniques for product development. Experience with small team project management. Experience working with Product Managers, Sales, and Management on strategic planning. Test & Measurement Instrument Design experience. Benefits: Great competitive salary, full benefits package which includes Medical, Dental, Vision, PTO. Holidays, 401K+match Join a wonderful working culture and team, working with established product line and creating other products as well with a well-established Global organization.
    $71k-99k yearly est. 18d ago
  • Specialist: Quality Assurance and Training - Patient Access

    Kennedy Medical Group, Practice, PC

    Quality assurance engineer job in Montgomery, PA

    Job Details Primary Function: Assist in facilitating the work of Quality Assurance, review and improve accuracy of Front End Revenue Cycle which includes front end billing edits, front end denials, zero accounts and any other front end related revenue opportunity. Participate in and coordinate the implementation of strategies and processes. Participation and coordination of creation of payor update guides. Participate and create training manuals. Provide training and mentoring to new registrars on all shifts and current registrars in front end denial and edit findings. Identify and report ongoing issues and possible resolutions. Provide statistics to management. Responsible for presenting standard training programs, prepares course materials, establishes lesson plans and administers qualifying tests. Provides office support for all computer applications, office procedures and protocols. Run detailed statistics to determine what areas need improvement, where denials are happening, determine how to correct processes to prevent, bring information to denial meetings. Work with internal and external customers. Job Description Education/Training/Experience: BA or BS in related field preferred OR 3-5 years in Patient Access and/or Patient Accounting Experience. Strong verbal and written communication skills required. 1-3 years lead or supervisory experience preferred. Patient Registration, third party billing, precertification, insurance verification experience required. Working knowledge of registration and billing regulatory requirements including EMTALA. Ability to prioritize tasks. Excellent PC literacy skills required. Candidate must have a positive and strong work ethic. EPIC AND CERNER EXPERIENCE STRONGLY PREFERRED Work Shift Rotating (United States of America) Worker Sub Type Regular Employee Entity Albert Einstein Medical Center Primary Location Address 559 W. Germantown Pike, East Norriton, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here
    $58k-90k yearly est. Auto-Apply 3d ago
  • Engineer I, Robotics Automation Support

    Oishii Farms

    Quality assurance engineer job in Phillipsburg, NJ

    Engineer I, Robotics Automation Support Oishii is seeking an Engineer 1- Robotics Automation Support to join our growing team! As an Engineer I, Robotics Automation Support you will: Observe and track performance of robotic system and triage with other engineers to improve the system Assemble, install and test upgrades and components of an operating robotic system Install and troubleshoot electrical, mechanical, computer, and controls or automation systems Report out to and take direction from engineering technical experts Utilize hand tools and fabrication equipment safely and effectively Fabricate and deploy upgrades to existing facilities Monitor facility performance and collaborate with engineers and maintenance staff to ensure consistent and improving performance Keep on top of issue tracking, management and triage to push performance forward Read and implement engineering designs and modifications from documentation Build documentation and develop installation guides and manuals to unlock more efficient future work and maintenance Deliver creative solutions to new problems and collaborate with technical designers and R&D staff to rapidly overcome challenges Maintain Safety standards at all times Drive projects that will build your expertise across various disciplines, including: Controls, industrial automation, and robotics Who will love this job: Individuals who identify with our Core Values and exhibit skills within those values will thrive at Oishii. * One Team, One Fight! * Ability to quickly shift priorities to meet deadlines and effectively communicate, both verbally and in writing, clearly, concisely and with purpose at various levels of the organization. * Ability to work cross functionally at all levels including across locations, and collaborate with a focus on supporting & understanding the evolving business needs of a startup environment. * Ability to lead through others and develop teams with a diverse level of experience to succeed. * Focus. * Ability to remove obstacles in order to prioritize which could include problem solving, working through ambiguity and using fact based or sound judgment in the absence of process or policy. We are building it, but need to manage through the process with good judgment and a bias for action. * Ability to synthesize information quickly to aid in the troubleshooting process. * GSD (Get Sh Done!) * Possessing an entrepreneurial mindset with the tenacity to develop ideas, process, and policy and implement them rapidly. * Capable of prioritizing tasks and considering the resources available when doing so. * A bias for action! Ability to hold yourself accountable and take ownership of driving results that impact company outcomes. * Track record of effectively handling complex employee relations issues, and addressing sensitive information and difficult situations with tact, discretion, and confidentiality. What we look for in a Engineer I, Robotics Automation Support: * Associates or Bachelors Degree in a Technical Field, Robotics, Mechanical or Electrical Engineering, Computer or SW engineering or related technical field * Strong knowledge of core engineering principles or hands-on learning of the same. * Strong ability to get cross-disciplinary technical work done and track record of bringing concepts to life. * Familiarity with basic Linux CLI and a willingness to learn more, knowledge of a programming language like Python a plus * Self-motivated team player eager to tackle complex projects * Excellent time management skills with a proven ability to meet deadlines * Experience with the safe use of basic hands tools * Thrives working hands-on with electrical, mechanical, and automation systems * Excellent troubleshooting and diagnostic skills Physical Requirements: * Must be comfortable using tools hands-on * May lift and/or otherwise move 45 pounds or more * Work at varying heights and from ladders and scissor lifts Perks at Oishii: * Compensation :: $72,000 with Equity * Medical, Dental, Vision Insurance * 401(k) Retirement Plan (Roth & Traditional) * EAP Access * 100% Employer Paid Life Insurance & Long Term Disability Insurance * Paid Parental leave, Paid Time Off & Paid Sick Time * Paid Training & 7 Paid Holidays * Office social events including happy hours, parties, and community service projects * Employee activity groups for basketball players, Yoga Enthusiasts, runners… About Us: At Oishii, we grow the best berries in the world by deploying ground-breaking vertical farming technology that pushes the boundaries of agriculture. We're the first in the WORLD to grow fruit in an indoor vertical farm at commercial scale. Our proprietary technology enables us to grow the very best produce year-round, at the same high level of quality, all without using any pesticides. Oishii has been profiled in Eater, NPR, Time Magazine, and Fortune. Oishi was also one of the Fast Companies Most Innovative Companies of 2022. At Oishii, everything we do works toward accomplishing our mission of transforming agriculture sustainably while bringing produce that truly delights people everywhere. This requires farmers, engineers, scientists, product managers, and members of many other backgrounds to work together day-in and day-out to innovate, while operating increasingly large farms. We have an amazing mission-driven team of highly motivated and engaged members. Learn More ********************
    $72k yearly 4d ago
  • Clinical Laboratory QA Coordinator - Molecular and Microbiology

    Labcorp 4.5company rating

    Quality assurance engineer job in Raritan, NJ

    Labcorp is seeking a Laboratory Quality Assurance Coordinator to join our team in Raritan, NJ. The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other LabCorp sites. This position is a great opportunity for laboratory professionals that have an eye for detail and a passion for quality assurance. **Pay Range: $29.00 - 33.00/hr. All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Work Schedule: Monday - Friday (8:30am - 5:00pm) Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Job Responsibilities: Support projects and activities related to quality assurance, control, improvement and training Prepare and support the laboratory for regulatory inspections Maintain all necessary documents and materials required for inspections Provide backup inspection support to laboratory during inspections Keep up with all required proficiency testing and examinations Coordinate and track external and internal proficiency testing Perform internal audits and prepare audit reports Prepare reoccurring quality reports for laboratory operations Stay current with all regulatory agency and proficiency test requirements Provide proper initiation and use of Master Control forms for audit purposes Participate in monthly Quality Meeting and compose minutes Perform administrative and clerical duties as needed Requirements: Bachelor's degree in Chemical or Biological science, Clinical Laboratory Science, Medical Technology or a non-traditional Bachelor's degree that meets local regulatory (CLIA & State) requirements Minimum 1 year of experience as a Technologist or in a quality related position Prior experience in a clinical laboratory is highly preferred Prior experience in microbiology and/or molecular is preferred General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements Basic understanding of audit related requirements and procedures Working knowledge of quality assurance best practices and procedures Excellent analytical, critical thinking and problem solving skills Strong communication skills; both written and verbal High level of attention to detail with strong organizational skills Ability to work independently and within a team environment Strong computer skills with proficiency with MS Office programs Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $29-33 hourly Auto-Apply 1d ago
  • Quality Assurance Associate

    Eminent, Inc.

    Quality assurance engineer job in Shoemakersville, PA

    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.
    $47k-69k yearly est. Auto-Apply 60d+ ago
  • Software Engineer, Android Core Product - Allentown, USA

    Speechify

    Quality assurance engineer job in Allentown, PA

    The mission of Speechify is to make sure that reading is never a barrier to learning. Over 50 million people use Speechify's text-to-speech products to turn whatever they're reading - PDFs, books, Google Docs, news articles, websites - into audio, so they can read faster, read more, and remember more. Speechify's text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its Design award winner for inclusivity for 2025. Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting - Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies. Overview With the growth of our Android app, being the most used text-to-speech app in the Play Store, we find the need for a Senior Android Engineer to help us support the new user base as well as work on new and exciting projects to push us forward. This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, passionate about making product decisions, and has experience building great user experiences that delight users. We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. Our interview process involves several technical interviews and we aim to complete them within 1 week. What You'll Do Owning major features and working closely with our design team - take ownership of features inside the app and become responsible of delivering high quality features Shape the future of our Android team Own, maintain and improve reliability metrics for key features Participate in discussions across different teams - Product, Design, Engineering Review pull requests, and support other teammates Handle critical issues or cope with unexpected challenges Take ownership of feature releases and provide nightly builds for the QA team An Ideal Candidate Should Have 5+ years of software engineering experience Familiarity with Android components Experience building or contributing to at least one Android app Product design intuition and user empathy Drive to push the boundaries of Android UI/UX Understanding of the importance of tests and how to approach writing tests Self-drive to improve the app and codebase above and beyond what's outlined in the spec Rock solid experience with Kotlin, Kotlin Coroutines, Kotlin Flow, Dagger 2, MVVM, Clean Architecture, Background Services, Music Player Service, Android Animations, Jetpack Navigation, JUnit tests Excellent communication skills User oriented problem solving approach Driven with continuous feedback from leaders Bonus: Experience building, maintaining, or otherwise contributing to open source projects in Android Experience with iOS, Web or NodeJS Technologies we use: Kotlin Kotlin Coroutines Kotlin Flow Jetpack Navigation Dagger 2 Room Custom Views, Canvas & Paint Jetpack Compose JUnit What We offer: A fast-growing environment where you can help shape the company and product. An entrepreneurial-minded team that supports risk, intuition, and hustle. A hands-off management approach so you can focus and do your best work. An opportunity to make a big impact in a transformative industry. Competitive salaries, a friendly and laid-back atmosphere, and a commitment to building a great asynchronous culture. Opportunity to work on a life-changing product that millions of people use. Build products that directly impact and support people with learning differences like dyslexia, ADD, low vision, concussions, autism, and more. Work in one of the fastest growing sectors of tech, the intersection of artificial intelligence and audio. The United States Based Salary range for this role is: 140,000-200,000 USD/Year + Bonus + Stock depending on experience Think you're a good fit for this job? Tell us more about yourself and why you're interested in the role when you apply. And don't forget to include links to your portfolio and LinkedIn. Not looking but know someone who would make a great fit? Refer them! Speechify is committed to a diverse and inclusive workplace. Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
    $69k-93k yearly est. Auto-Apply 53d ago
  • Quality Assurance Assistant

    SST Direct 4.2company rating

    Quality assurance engineer job in Allentown, PA

    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
    $19-23 hourly Auto-Apply 7d ago
  • QA Shop Floor Specialist III

    Legend Biotech 4.1company rating

    Quality assurance engineer job in Raritan, NJ

    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 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: Sun-Wed 1 st 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.
    $76k-99.7k yearly Auto-Apply 1d ago
  • Clinical Laboratory QA Coordinator - Molecular and Microbiology

    Labcorp 4.5company rating

    Quality assurance engineer job in Raritan, NJ

    Labcorp is seeking a Laboratory Quality Assurance Coordinator to join our team in Raritan, NJ. The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other LabCorp sites. This position is a great opportunity for laboratory professionals that have an eye for detail and a passion for quality assurance. ****Pay Range: $29.00 - 33.00/hr.** All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. **Work Schedule:** Monday - Friday (8:30am - 5:00pm) **Benefits:** Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here (************************************************************** **.** **Job Responsibilities:** + Support projects and activities related to quality assurance, control, improvement and training + Prepare and support the laboratory for regulatory inspections + Maintain all necessary documents and materials required for inspections + Provide backup inspection support to laboratory during inspections + Keep up with all required proficiency testing and examinations + Coordinate and track external and internal proficiency testing + Perform internal audits and prepare audit reports + Prepare reoccurring quality reports for laboratory operations + Stay current with all regulatory agency and proficiency test requirements + Provide proper initiation and use of Master Control forms for audit purposes + Participate in monthly Quality Meeting and compose minutes + Perform administrative and clerical duties as needed **Requirements:** + Bachelor's degree in Chemical or Biological science, Clinical Laboratory Science, Medical Technology or a non-traditional Bachelor's degree that meets local regulatory (CLIA & State) requirements + Minimum 1 year of experience as a Technologist or in a quality related position + Prior experience in a clinical laboratory is highly preferred + Prior experience in microbiology and/or molecular is preferred + General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements + Basic understanding of audit related requirements and procedures + Working knowledge of quality assurance best practices and procedures + Excellent analytical, critical thinking and problem solving skills + Strong communication skills; both written and verbal + High level of attention to detail with strong organizational skills + Ability to work independently and within a team environment + Strong computer skills with proficiency with MS Office programs **Labcorp is proud to be an Equal Opportunity Employer:** Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. **We encourage all to apply** If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (**************************************************** or contact us at Labcorp Accessibility. (Disability_*****************) For more information about how we collect and store your personal data, please see our Privacy Statement (************************************************* .
    $29-33 hourly 2d ago
  • Software Engineer, iOS Core Product - Allentown, USA

    Speechify

    Quality assurance engineer job in Allentown, PA

    Job Description The mission of Speechify is to make sure that reading is never a barrier to learning. Over 50 million people use Speechify's text-to-speech products to turn whatever they're reading - PDFs, books, Google Docs, news articles, websites - into audio, so they can read faster, read more, and remember more. Speechify's text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its App of the Day. Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting - Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies. Overview With the growth of our iOS app, being the #18 productivity app in the App Store category and also our recent recognition as Apple's 2025 Design Award for inclusivity, we find the need for a Senior iOS Engineer to help us support the new user base as well as work on new and exciting projects to push our missing forward. This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, passionate about making product decisions, and has experience building great user experiences that delight users. We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. Our interview process involves several technical interviews and we aim to complete them within 1 week. What You'll Do Opportunity to lead key engineering and product decisions Actively shipping production code for the Speechify iOS app Work within a dedicated product team Participate in product discussions to shape the product roadmap Maintain and enhance the existing complex app architecture An Ideal Candidate Should Have Experience. You've worked on products that scaled to a large user base Track record. You have worked on various products from inception to decent traction. You have been responsible for engineering the product Customer obsession. We expect every team member whose responsibilities directly impact customers to be constantly obsessed about providing the best possible experience Product thinking. You make thoughtful decisions about the evolution of your product and support internal teams and designers into taking the right direction Speed. You work quickly to generate ideas and know how to decide which things can ship now and what things need time Focus. We're a high-growth startup with a busy, remote team. You know how and when to engage or be heads down Technical skills. Swift, SwiftUI Technical Requirements: Swift Programming Language SwiftUI experience Experience in Multithreading Programming Working with CI/CD infrastructure Experience with Fastlane SOLID principles, the ability to write every single class according to SOLID Experience with Git and understanding of different Git strategies What We offer: A fast-growing environment where you can help shape the company and product An entrepreneurial crew that supports risk, intuition, and hustle The opportunity to make a big impact in a transformative industry A competitive salary, a collegiate atmosphere, and a commitment to building a great asynchronous culture Work on a product that millions of people use and where daily feedback includes users sharing that they cried when they first found the product because it was so impactful on their lives Support people with learning differences like Dyslexia, ADD, Low Vision, Concussions, Autism, and Second Language Learners, and give reading superpowers to professionals all over the world Work in one of the fastest growing sectors of tech: Intersection of Artificial Intelligence and Audio The United States Based Salary range for this role is: 140,000-200,000 USD/Year + Bonus + Stock depending on experience Think you're a good fit for this job? Tell us more about yourself and why you're interested in the role when you apply. And don't forget to include links to your portfolio and LinkedIn. Not looking but know someone who would make a great fit? Refer them! Speechify is committed to a diverse and inclusive workplace. Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
    $69k-93k yearly est. 26d ago
  • Quality Assurance Assistant

    SST Direct 4.2company rating

    Quality assurance engineer job in Quakertown, PA

    Job DescriptionDIRECT 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 Powered by JazzHR 01xLEG58Al
    $19-23 hourly 9d ago
  • Software Engineer, Platform - Allentown, USA

    Speechify

    Quality assurance engineer job in Allentown, PA

    Job Description The mission of Speechify is to make sure that reading is never a barrier to learning. Over 50 million people use Speechify's text-to-speech products to turn whatever they're reading - PDFs, books, Google Docs, news articles, websites - into audio, so they can read faster, read more, and remember more. Speechify's text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its 2025 Design Award winner for Inclusivity. Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting - Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies. Overview The responsibilities of our Platform team include building and maintaining all backend services, including, but not limited to, payments, analytics, subscriptions, new products, text to speech, and external APIs. This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, is passionate about making product decisions, and has experience building great user experiences that delight users. We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. Our interview process involves several technical interviews and we aim to complete them within 1 week. What You'll Do Design, develop, and maintain robust APIs including public TTS API, internal APIs like Payment, Subscription, Auth and Consumption Tracking, ensuring they meet business and scalability requirements Oversee the full backend API landscape, enhancing and optimizing for performance and maintainability Collaborate on B2B solutions, focusing on customization and integration needs for enterprise clients Work closely with cross-functional teams to align backend architecture with overall product strategy and user experience An Ideal Candidate Should Have Proven experience in backend development: TS/Node (required) Direct experience with GCP and knowledge of AWS, Azure, or other cloud providers Efficiency in ideation and implementation, prioritizing tasks based on urgency and impact Preferred: Experience with Docker and containerized deployments Preferred: Proficiency in deploying high availability applications on Kubernetes What We Offer A dynamic environment where your contributions shape the company and its products A team that values innovation, intuition, and drive Autonomy, fostering focus and creativity The opportunity to have a significant impact in a revolutionary industry Competitive compensation, a welcoming atmosphere, and a commitment to an exceptional asynchronous work culture The privilege of working on a product that changes lives, particularly for those with learning differences like dyslexia, ADD, and more An active role at the intersection of artificial intelligence and audio - a rapidly evolving tech domain The United States Based Salary range for this role is: 140,000-200,000 USD/Year + Bonus + Stock depending on experience Think you're a good fit for this job? Tell us more about yourself and why you're interested in the role when you apply. And don't forget to include links to your portfolio and LinkedIn. Not looking but know someone who would make a great fit? Refer them! Speechify is committed to a diverse and inclusive workplace. Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
    $69k-93k yearly est. 26d ago

Learn more about quality assurance engineer jobs

How much does a quality assurance engineer earn in Allentown, PA?

The average quality assurance engineer in Allentown, PA earns between $60,000 and $103,000 annually. This compares to the national average quality assurance engineer range of $61,000 to $109,000.

Average quality assurance engineer salary in Allentown, PA

$79,000

What are the biggest employers of Quality Assurance Engineers in Allentown, PA?

The biggest employers of Quality Assurance Engineers in Allentown, PA are:
  1. Thermo Fisher Scientific
  2. Invitrogen Holdings
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