Quality Assurance Manager Jobs in West Deptford, NJ

The Opportunity: Avantor is looking for a Quality Engineer II to support our chemical manufacturing facility in Phillipsburg, NJ! The Quality Engineer II leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Quality Engineer II is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation. This is a full-time, onsite position in Phillipsburg, NJ (1st Shift, Monday - Friday). What we're looking for Education: Bachelor's Degree in chemistry or a related field required Experience: Minimum of five (5) years of experience in quality engineering or a related role required Experience working within pharmaceutical, biotechnology and/or chemical environments required Experience working within cGMP/ISO 9000 regulated environments required Excellent writing and presentation skills Demonstrated ability to accomplish goals through others Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods Ability to merge divergent resources into an effective and efficient cross-functional team Highly detail oriented with demonstrated strong analytical and problem-solving skills Ability to navigate in a matrixed environment and work collaboratively in a team environment Excellent organization and project management skills Ability to interface effectively with people at all levels of the organization, from executive to production line How you will thrive and create an impact Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements Performs internal audits at other Avantor sites and may participate in supplier audits as required Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required Provides GMP and GDP training to site personnel Leads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAs Works with and provides input to Management of Change process Performs statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and products Works collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaint Partners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams Works with all departments to investigate and resolve process and product quality issues Performs other duties as assigned with or without accommodation Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at ****************************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision. 3rd Party Non-Solicitation Policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Our client is looking for a Quality Control Lab Manager. Responsibilities: Staff management of quality control analysts and environmental monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourced Maintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems Ensure all method validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays Management oversight of staff and day to day operations Required Qualifications: Cell Biology Assay required Experience in aseptic processing and/or mammalian cell culture production Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards Writing experience in a similar role in the biologics or pharmaceutical industry Clinical Resource Network Distinction CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve. About CRN Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit ******************************* and connect with us on Facebook and LinkedIn. Opportunity Awaits.

CBH is a dynamic organization dedicated to providing access to high-quality, accountable care to improve the health and mental wellness of our members. As part of our growth, we are seeking a detail-oriented Performance Evaluation Specialist to join our team. CBH offers a robust compensation and benefits package, including: Family Planning, Fertility, Adoption Benefits 403B Retirement Plan PTO Days/Sick Days Wellness Program Employee Assistance Program Health, Dental, Vision Insurance Medical, Prescription Drug Insurance Tuition Reimbursement Commuter Benefits Flexible Spending Position Summary: The Quality Management Performance Evaluation Specialist is responsible for planning, designing, implementing, conducting, and reporting performance evaluation activities. Essential Functions: Work with the Health Effectiveness Data and Information Set (HEDIS) vendor to report HEDIS measure performance data Work cross-departmentally to create Clinical Practice Guidelines that assess the quality of service delivery by CBH providers Monitor provider data reporting and provide technical assistance for quality improvement Monitor and evaluate provider root cause analyses and corrective action plans Collaborate with the Data Analytics team to synthesize and analyze claims data to support performance evaluation activities Work with internal (Clinical Care Management, Executive Team, Quality Improvement, etc.) and external (providers) stakeholders on sharing measurement data and evaluation results Support development of reliable data collection tools (e.g. creation of provider and member surveys, provider performance evaluation plans) Participate in cross-departmental work groups Conduct Plan-Do-Study-Act (PDSA) Cycles with providers as appropriate Other duties as assigned Position Requirements: Education: Master's degree in behavioral health, healthcare, or social sciences, with experience with quantitative and qualitative research methods, tool design and validation License/Certification (if applicable): CPHQ Certification preferred or willingness to obtain certification within 1 year of CBH employment Relevant Work Experience: Minimum of 3 years post-graduate experience Skills : Mid to high level proficiency with Microsoft Office applications, especially Microsoft Excel Excellent written and verbal communication skills Detail-oriented and highly organized Knowledge of quality management, assurance, and improvement principles Ability to work with individuals across all levels of the organization (including, but not limited to: Officers, Directors, Managers, peers, etc.) Knowledge of different models for continuous process improvement (e.g. Deming Cycle/Plan-Do-Study-Act, Root Cause Analysis, Fishbone Diagrams) Philadelphia Residency Requirement: The successful candidate must be a current Philadelphia resident or become a resident within six months of hire. U.S. Authorization Requirement: CBH does not provide sponsorship for applicants requiring future work authorization. All candidates must be legally authorized to work in the United States without requiring sponsorship now or in the future. Equal Employment Opportunity: We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CBH is an equal opportunity employer. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on all qualified individuals. This is without regard to race, ethnicity, creed, color, religion, national origin, age, sex/gender, marital status, gender identity, sexual orientation, gender identity or expression, disability, protected veteran status, genetic information or any other characteristic protected individual genetic information, or non-disqualifying physical or mental handicap or disability in each aspect of the human resources function by applicable federal, state, or local law. Requesting An Accommodation: CBH is committed to providing equal employment opportunities for individuals with disabilities or religious observance, including reasonable accommodation when needed. If you are hired by CBH and require an accommodation to perform the essential functions of your role, you will be asked to participate in our accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodation once hired. If you would like to be considered for employment opportunities with CBH and have accommodation needs for a disability or religious observance, please send us an email at ************************* Compensation details: 59600-67000 Yearly Salary PI85c7e2ae71aa-26***********7

Ten plus years of experience with SAP S/4 HANA Finance. Extensive experience with SAP Concur and Epicor Eclipse ER. Ten plus years or more experience running & developing an IT Quality Assurance Program from the grass roots. Have experience with test automation tools and frameworks. Demonstrate excellent leadership and people management skills, with the ability to motivate and inspire teams. Demonstrate strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders. Collaborate with stakeholders, managers, and development teams to define quality standards, goals, and objectives.

The Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to procedures by supporting laboratory investigations and manufacturing deviation reviews. Monday to Friday-Standard Hours. 4 roles needed. Position is 100% on site. Essential Functions and Responsibilities Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and escalate to management. Responsible for providing quality oversight for site manufacturing operations and quality control at the iCTC. Accurate and timely maintenance and review of procedures, methods, protocols, and reports as required Collaborate with internal functions to address all identified issues in a timely manner. Determine how best to document issues requiring investigation within the Quality System. Providing Quality and compliance oversight to manufacturing, QC, and MSAT Coordinating deviation and investigation reviews to support release of final product and materials. Ensure accurate and timely review of manufacturing and laboratory investigations Identifying and escalating any trends to management Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release. Ensure deviations and investigations do not adversely impact timely lot closure, as required. Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge A Bachelor's Degree in Science, Engineering, or a related technical discipline. At least five years of experience in a regulated industry. Proficient knowledge of cGMP regulations. Perform routine activities with minimal oversights. Prior experience with review of Manufacturing and/or QC data specific to cell therapy testing preferred. Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint. Must be skilled in planning and organizing, decision-making, and building relationships Able to effectively work in a dynamic / fast-paced environment Extremely detail oriented with strong technical skills. Knowledge of MasterControl is preferred. High level of accountability and ownership. Demonstrate a sense of urgency ability to recognize time sensitivity. Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. Successfully interface with multidisciplined teams. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: Must be able to remain in a stationary position standing or sitting for prolonged periods of time. Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline Work Environment: This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. 616127

Quality Assurance Specialist Type: on site in King of Prussia Company: SK Pharmteco The Quality Assurance Specialist supports the organization by establishing/enforcing quality systems, drive growth, and ensure quality among the site. The QA Manufacturing Operations Specialist supports Manufacturing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site's production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines. Responsibilities: • Support on the floor activities through shop floor QA procedures. • Assist in management and triage of on the floor events and schedule of on the floor support across specialists. • Provide Quality input and guidance for deviations, technical documentation, program/process optimization projects, and audit readiness initiatives. • Review minor deviations and recommend CAPAs and effective checks to ensure robust investigations and actions. • Review Change controls and continuous improvement records. • Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities • Compile batch documentation and generate Certificate of Conformance for release of manufacturing batches within assigned timelines to effectively deliver results to client. • Ability to review data and effectively identify trends or key issues. • Ensure facility follows current GMP standards (cGMP) • Support the development of quality systems including a robust and on-going quality improvement system compliant with GMP. • Review pre executed and executed master batch records and facilitate comment resolution with applicable manufacturing teams. • Review process flow diagrams to support tech transfer program initiatives • Sit in on internal client calls and support external calls as applicable to ensure timeline deliverables and compliance to procedures. • Work with QA and management to collaborate with clients to generate labels for client programs. • Complete line clearance and changeover activities to support product campaigns. • Print master batch records to support client programs and internal manufactured products and aseptic manipulation qualifications. • Oversee Aseptic process qualifications (APS) and vial inspections for APS and Drug product. • Review environmental monitoring(EM) data to support changeover of suites as well as in process EM. • Review material specs to support client programs. • Review and approve new procedures. • Facilitate review of document change controls for SOP revisions. • Additional duties as assigned. Requirements: •Minimum 5-7 years' experience in the pharmaceutical or biopharmaceutical industry •Minimum 3 years' experience in a quality role in pharmaceutical or biopharmaceutical industry • Proficient in Verbal and Written communication skills • Excellent problem solving, risk analysis and negotiation skills • Ability to review data and effectively identify and trends or key issues • Ability to manage multiple projects simultaneously ensuring on time execution of deliverables • Flexibility to support operations as needed N/A As an Equal Opportunity Employer, we believe in each person's potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status

Avkin is looking for a motivated Electronics Engineering Manager to join our Research and Development team in Wilmington, Delaware! This role will shape the electronics development of the next generation of devices that are pioneering healthcare education through wearable technology. As the Electronics Engineering Manager you will effectively coordinate new product design, as well as improvements to existing products, by leading the team through component evaluation, PCB design, and embedded software development. This exciting opportunity will allow you to leverage your expertise in project management while maintaining direct contact with the details of electronics development as you work to create the products that will be used by future healthcare professionals. About the Company: Avkin is an innovative, trend setting company raising the bar to reduce patient suffering in healthcare through excellence in simulation education. We imagine, create, and refine teaching modalities that incorporate standardized patients (live patient actors) and wearable technology to create the most realistic healthcare scenarios for learners to master therapeutic communication, empathy, psychomotor skills, and critical thinking. We are the most ambitious company in the industry looking to disrupt the status quo (manikin training). Responsibilities: Lead the electronics team to design, prototype, validate, and implement both hardware and embedded software solutions for wearable devices Mentor and coach the team in engineering best practices, task management, root cause analysis, and design for manufacturing Create schematics and design PCBs for use with embedded systems devices Develop embedded software, including microcontroller firmware development in C, for use with sensors, motor controls, etc. Ensure tasks are completed effectively and on time by managing team responsibilities, priorities, and resources Effectively communicate with technical and non-technical team members to present concepts, designs, and roadblocks throughout the development and implementation of products Develop and test prototypes to learn quickly, receive feedback, and make insightful recommendations based on findings Use laboratory equipment to develop and troubleshoot prototypes through a working knowledge of hand soldering techniques, oscilloscopes, multimeters, power supplies, current probes, signal analyzers, etc. Ensure current and future designs comply with applicable regulatory standards, such as RoHS and CE Create and maintain effective project documentation for hardware and software development Test refined prototypes with customers and modify designs based on feedback Improve upon existing products and processes by identifying opportunities, implementing customer requests, and streamlining manufacturing processes Work closely with in-house manufacturing team to successfully navigate new product rollouts and product improvements, as well as maintain the current product offering Sustain and enhance personal and team knowledge on trends in the field of electronics development and manufacturing technology Job Requirements: Bachelor's degree in electronics engineering, electrical engineering, computer science, or related field 3-7 years of hands-on experience in electronics design and development 1+ years of team leadership and/or project management experience Self-motivated, organized, efficient, and process oriented with a strong work ethic Able to define problems, collect and organize data, analyze the data to develop and prove a hypothesis, and articulate results/conclusions Experience with PCB design software (Altium, Eagle, etc.) as well as knowledge of industry best practices for analog and digital circuit layout Experience with embedded C programming and development (ARM based microcontrollers, microcontroller architecture, serial communication, sensor integration, motor controls, etc.) Experience with hands-on electronics prototyping, including hand soldering, PCB assembly, and circuit testing Experience with electronics troubleshooting through a working knowledge of equipment such as oscilloscopes, multimeters, power supplies, current probes, signal analyzers, etc. Knowledge of SMT soldering and reflow techniques Experience with regulatory requirements is a plus Experience working with wearable and battery powered design constraints is a plus Avkin offers the following Benefits: Medical Insurance Short Term Disability 401 K Dental, Vision, Accident, and Hospitalization Insurance (optional) Paid Time Off Sick Leave Please note that we are unable to provide visa sponsorship for this position. Applicants must be legally authorized to work in the United States without requiring sponsorship for employment now, or in the future. More about us! ******************

About Taylor Fresh Foods, Inc. Taylor Fresh Foods, Inc. is dedicated to being North America's favorite maker of salads and healthy fresh foods. Our “Taylor Family” includes over 20,000 team members who are passionate about making high quality, great tasting products for families across North America. As we continue to rapidly grow, we have a career opportunity available for a talented and motivated individual to join our Taylor Farms New Jersey team as Quality Improvement Supervisor. JOB SUMMARY: The Quality Improvement Supervisor is responsible for ensuring the overall consistency and quality of manufactured items throughout the production facility. This role will be responsible for ensuring the quality of manufactured items are meeting internal/customer specifications along with customer expectations. A key piece to this role is the ability to implement programs that are executable by the production operators to ensure sustainability. The Quality Improvement Supervisor is also responsible for training and reinforcement training of associates, leads, and Quality improvement coordinators as it relates to quality. This role requires interaction with associates and management but is ultimately a floor driven position as product consistency and quality are driven at the floor level. Key deliverables include: Partner with production leads, supervisors and quality leadership to develop and foster consistency around production execution. Work with Quality and Process Improvement manager to address areas of opportunity for existing product set and around commercialization efforts for new products to be produced in a given production area. Gather ideas and opportunities from the production floor to come up with quality opportunities. Help guide production supervision with completion of priority tasks as it relates to quality. Aid in execution and awareness of all new quality processing procedures. Work with QIC's and operators on proper builds and portioning during the production run. Manage day to day of the Quality improvement coordinators. Qualifications/Skills and Abilities: Bachelor's degree in related field (industrial engineering, food marketing/production, manufacturing, food science, etc.), preferred. Minimum 3 years of experience in food manufacturing company, specifically around leafy greens. Must be a self-starter capable of independently meeting objectives and interacting with members of various teams successfully. Able to think creatively and strategically. At home in a manufacturing environment and on the production floor. Ability to elicit buy-in and cooperation from a variety of individuals as well as departments. Hands-on, flexible, and responsive to dynamic fast paced work environment. Capability of multitasking and managing several initiatives. Strong team player with a continuous improvement mindset. Bi-lingual (English/Spanish) is required.

Qualifications The primary role will be to support the Quality Management Systems teams with various tasks including, but not limited to documentation and project support activities. The role requires interaction with learning management systems; MyLearning and Quality Docs. Required Education & Skills: * Bachelor's Degree in an appropriate scientific or business field of study * Minimum of five (5) years' experience in the Pharmaceutical or equivalent industry * Strong technical knowledge, skills, and experience in project and documentation management Preferred Education & Skills: * Excellent verbal and written communication skills as well as presentation skills * Strongly developed cross-functional teamwork and collaboration skills * Experience in Microsoft tools such as Outlook, Word, Excel, PowerPoint, SharePoint, Teams and Project is strongly recommended * Experience with document editing in MS Word (e.g. formatting, forms, styles, templates, etc.) * Experience directly related to the development of Quality Standards and core requirements for Market Supply and/or Clinical Supply * Experience directly related to Quality Assurance, Quality Control, GMP regulations or pharmaceutical regulations * Knowledge of processing mapping and optimization. Responsibilities Primary Responsibilities include. * Key collaborator working closely with site personnel and Clinical Supply QMS Redesign Team to ensure successful implementation of new QMS by assisting with project-specific tasks, including but not limited to, project support, document management, documentation review, technical editing, meeting coordination and facilitation, training, onboarding, and other administrative tasks. Specific tasks may include: Perform documentation review and technical editing to ensure consistency (e.g. language, formatting, etc.) within the Redesign Team and across the Clinical Supply network * Serve as a communication channel between global network site personnel * Assist with site metrics collection/reporting and sharing of success stories/achievements * Support development of the learning strategy for new and revised QMS topics, including access to LMS content and generation of reports, creation of training materials and communication of training requirements * Support project management activities, optimization of communication strategy and change management strategy * Management of document lifecycle (new or existing documents) and review/approval workflows * Maintain electronic repository/communication mechanism (e.g. QMS SharePoint Site, Microsoft Teams) * Serve as a change agent helping the Clinical Supply QMS Redesign Team drive culture change.

Workday Test Lead Duration: 6 Months Workday Test Lead Job Description: The Test Lead is responsible for managing a team tasked with testing the implementation of Workday. The team's focus areas include Financial and Grants testing; and Procurement and Supply Chain testing; HCM and Payroll Testing, Reporting, Integrations and Data Conversion testing. The purpose of this position is to work with a team of internal employees and implementation consultants to conduct initial user acceptance testing, train personnel, help to integrate the system with other internal software and launch the software. As Workday is a Software as a Service (SaaS) model for which there are semi-annual releases, there will be a need to develop a process to support, test and train on new functionality in 6 months.

Greetings everyone, Capgemini is currently seeking candidates for this position. If you are interested, please submit your application here. Test lead(Accessibility) Philadelphia, PA Fulltime Description - External Job description: This is a role for a Test Lead role that will have a focus in ensuring the quality E2E Testing deliverables KEY RESPONSIBILITIES: Capable of leading & mentoring Testing team while being responsible for E2E Testing co-ordination for the project with excellent communication skills Responsible for Test metrics, preparation, analysis, reporting and E2E testing deliverables... Function as the single point of contact to the client for co-ordination & other involved stakeholders for all aspects of Testing viz., releases, planning, support, execution etc. Experienced in creating Test execution report, Test Summary report, closure reports etc. Prepare test plans with scenarios, cases and steps. Maintenance of test plans across multiple systems Provide daily testing metrics/defect and defect/issue resolution by working with PM on test plan execution, risk identification and mitigation and project plan execution Good experience in Test management tools like JIRA Able to guide Test team & Automation team and complete the test activities within the sprint planning phase Required Skills: Manual Testing: Strong manual testing skills, including exploratory testing, usability testing, and edge case analysis, to catch issues that automated tests may miss. UI/UX Understanding: A deep understanding of user interface design principles and user experience (UX) best practices to assess design compliance and user satisfaction. Cross-Browser/Device Testing: Ability to test UIs across various browsers, devices, and screen sizes to ensure consistent functionality and appearance. Accessibility Testing: Familiarity with WCAG guidelines and tools to perform accessibility testing, ensuring compliance with accessibility standards. Regression Testing: Expertise in regression testing to identify and report defects and regressions in UI functionality accurately. API Testing: Proficiency in API testing to ensure smooth data exchange between the front-end and back-end components. Defect Tracking: Competence in using defect tracking tools (e.g., Jira) to document, prioritize, and communicate issues effectively. Test Documentation: Strong documentation skills to create detailed test plans, test cases, and test reports for comprehensive test coverage. Collaboration: Effective communication and collaboration with cross-functional teams, including developers, designers, and product managers, to ensure alignment on quality standards. Performance Testing: Basic understanding of performance testing tools (e.g., JMeter) to identify UI-related performance issues. Continuous Learning: A commitment to staying updated with evolving UI technologies, testing methodologies, and industry trends. Senior UI QA testers provide invaluable insights into the user experience and ensure that applications meet quality standards, making their role essential in software development projects. Maintenance of test cases, execution reports, producing test metrics. Presenting test case reports, metrics during sprint / PI demo Work with Product Manager/Business closely to produce a good coverage in-depth test cases and execution. Well versed on testing methodologies, test management, test designing and execution. Ability to work on enterprise E2E integration scenarios. Ability to create dashboard and publish reports and defect logging Good experience of defect management & defect triage meetings , Experience in working in Agile methodology, Scrum & huddle meetings Good experience on Jira , Good communication skills , Any Testing certification"" Knowledge of testing lifecycle and test processes is a must. Independently create, execute and maintain comprehensive Test Cases - Proficient in Manual Testing with a strong skill set. Extensive knowledge of SDLC, STLC, and Bug Life Cycle. Life at Capgemini Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer: Flexible work Healthcare including dental, vision, mental health, and well-being programs Financial well-being programs such as 401(k) and Employee Share Ownership Plan Paid time off and paid holidays Paid parental leave Family building benefits like adoption assistance, surrogacy, and cryopreservation Social well-being benefits like subsidized back-up child/elder care and tutoring Mentoring, coaching and learning programs Employee Resource Groups Disaster Relief About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.

Quality Assurance Engineering Specialist Are you looking to play a pivotal role in supporting the development and operations of a commercial-scale cGMP cell therapy manufacturing and laboratory facility? This exciting position offers the opportunity to provide quality oversight, collaborate with cross-functional teams, and ensure systems and equipment meet the highest quality standards throughout their lifecycle. Shift: Monday to Friday, 3:00 PM - 11:30 PM Key Responsibilities: Identify risks and develop mitigation strategies in collaboration with teams across Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation. Support quality improvement efforts for cGMP facilities and remote laboratories. Develop and maintain documentation, including quality manuals, SOPs, and work instructions. Ensure adherence to Good Manufacturing Practices (GMP). Represent Quality on cross-functional teams to address quality issues and implement system improvements. Provide technical guidance for quality engineering activities, including root cause analysis, corrective actions, and process changes. Oversee lifecycle verification programs for manufacturing and laboratory systems. Qualifications: Bachelor's degree in a scientific or engineering discipline. 3+ years of experience in the biopharmaceutical industry in a technical or support role. 2+ years of experience in GxP system implementation and validation. Experience in a Quality role is highly desirable. Strong knowledge of inspection/testing processes and lifecycle verification for single-use systems, lab systems, and software in a cGMP environment. Proven experience developing policies and procedures for new cGMP facilities. Exceptional communication, collaboration, and problem-solving skills. Proficiency in Microsoft Office Suite. Physical Demands: Ability to stand and walk for 90% of a 10-hour shift, with some crouching, bending, and climbing. Must be able to lift and carry objects weighing up to 45 pounds. Comfortable wearing cleanroom attire and PPE, including respirators. Work Environment: Split between office and manufacturing lab settings. Exposure to biohazards, chemicals, and equipment hazards in a cleanroom environment.

Avo Photonics (********************* is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to produce next generation products for a diverse range of markets including aerospace, military, medical, industrial, and communications. We seek a diligent, dedicated, and meticulous person who will help to further our success by supporting our aerospace quality system. An ideal candidate must take ownership over and strive for continuous improvement in the procedures and documentation that encompass our aerospace products. The candidate is expected to advise program managers and engineers on best-practice quality procedures, and should feel comfortable leading large-scale change within the programs they operate in. Proactivity, high attention to detail, and the ability to cooperate professionally within different levels of the organization are essential traits for success. Responsibilities: Develop and maintain manufacturing documents (component drawings, inspection documents, work instructions, travelers, and bills of materials) such that they are compliant to aerospace quality standards Managing first article inspections, nondestructive testing, and failure analysis (PFMEA, FMA), as required Ensuring all material compliances (Reach, RoHS, Conflict Minerals) and material traceability Collect and analyze production data to audit and confirm product quality Process nonconforming product and drive root cause analysis Support material source inspections and customer audits Maintaining quality documents and records Requirements: B.S. in Engineering At least 5 years of experience with electronic and/or optical technologies, measurement systems, and inspection tools At least 5 years of experience working in Quality Experience in aerospace and support of prior missions Experience managing within AS9100 & AS9003B Quality Systems preferred Strong oral and written English communications skills ASQ Quality Engineer Certification preferred Avo Photonics offers competitive salaries and a comprehensive benefits package. Equal Opportunity Employer: Avo Photonics is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee of Avo Photonics by any method without a valid written contract in place with Avo Photonics will be deemed the sole property of Avo Photonics. No fee will be paid in the event the candidate is hired by Avo Photonics as a result of the referral or through any other means. #aerospace

Due to a growing portfolio, we are currently looking for Project Quality and Risk Leads to be based in Serbia, Croatia or Turkey with flexible working hours. The Project Quality and Risk Lead assumes the lead (with support of LM or Mentor) of Quality oversight responsibility and partners with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance The Project Quality and Risk Lead is acting as Risk Manager being responsible to coordinate Critical to Quality (CtQ) identification, risk identification, evaluation and controls. This position can also be part of a global project management team Project Quality and Risk Lead assigned to projects will collaborate closely with the broader PQRM groups and other quality teams. Skills: Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback. Developing analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions. Ability to develop professional, collaborative relationships both internally and with the client. Developing skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues. Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge. Ability to plan, organize, prioritize and manage workload with LM guidance, keeping the patient and client at the focus. Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables. Developing the ability to manage the complexity of a matrix environment while valuing the importance of teamwork. Ability to travel about 20% Knowledge and Experience: Experience in clinical research. Experience using root cause methodologies (5-whys, fishbone diagram, etc.) Experience in Real World Evidence (RWE) in Health Economicsand OutcomesResearch(HEOR) Studies is a bonus Knowledge of ICH-GCP principles English and Local country language (written and oral) Education: Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you'll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology "super user" or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees. RequiredPreferredJob Industries Other

Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of innovative and fascinating businesses and create career opportunities across a wide range of locations and disciplines. We are at the forefront of change and move at an amazing pace, thanks to our remarkable people, who bring cutting-edge products and services to life for millions of customers every day. If you share in our passion for teamwork, our vision to revolutionize industries and our goal to lead the future in media and technology, we want you to fast-forward your career at Comcast. Skills: Leadership; Quality Assurance (QA); Quality Assurance Processes; Data Analysis; Data Validation; Quality Assurance Plans; Quality Assurance Management (QAM) Base pay is one part of the Total Rewards that Comcast provides to compensate and recognize employees for their work. Most sales positions are eligible for a Commission under the terms of an applicable plan, while most non-sales positions are eligible for a Bonus. Additionally, Comcast provides best-in-class Benefits to eligible employees. We believe that benefits should connect you to the support you need when it matters most, and should help you care for those who matter most. That's why we provide an array of options, expert guidance and always-on tools, that are personalized to meet the needs of your reality - to help support you physically, financially and emotionally through the big milestones and in your everyday life. Please visit the compensation and benefits summary on our careers site for more details. Education Bachelor's Degree While possessing the stated degree is preferred, Comcast also may consider applicants who hold some combination of coursework and experience, or who have extensive related professional experience. Relevant Work Experience 7-10 Years

QA Release Supervisor, Cell Therapy - Permanent - Philadelphia, PA Proclinical is working alongside a pharmaceutical company seeking a QA Release Supervisor, Cell Therapy to oversee and monitoring GMP release activities, including finished drug products. We are a growing company focused on the development and commercialization of immunotherapies based on tumor infiltrating lymphocytes (TIL). The Supervisor, Quality Assurance, Release, is a newly created position that requires a highly independent individual with strong communication skills. The position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between Manufacturing and Quality, with the goal of optimizing informed decision making. The position will be fluent in release processes and procedures. Primary Responsibilities: The successful candidate will act as a key point of contact between manufacturing and Quality teams, ensuring informed decision-making and compliance with release processes and procedures. Required Education, Skills, and Knowledge Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience. Minimum of 5 years of experience in biopharmaceutical-based GMP cell therapy or bioloigcs industry. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired. Quality release experience required. Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals; 21 CFR 1271 is a plus Excellent oral and written communication skills Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner Must be comfortable in a fast-paced environment and changing priorities Experience with use of an electronic QMS, Master Control This role is on-site, and shift based. The QA Release Supervisor, Cell Therapy's responsibilities will be: Essential Functions and Responsibilities Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence. Perform real-time support for escalations to ensure compliance with GMP and GDP quality initiatives. Ensure appropriate and timely escalation of significant quality issues Schedule and coordinate daily activities related to final drug product release, disposition, and lot closure ensuring conformance to the daily schedule and overall site compliance. Support raw material, component, and kit release as required. Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements. Support final product drug label issuance and reconciliation Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. Drive continuous improvements to systems, policies, procedures, and ways of working to create a more efficient release process that is agile, nimble, compliant, and meets the needs of the business to serve autologous cell therapy patients. Review of Quality System records for compliance. Must adhere to our core values, policies, procedures, and business ethics. Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. Perform miscellaneous duties as assigned. Provide support for Iovance audits as required Track data for Quality Release metrics as required Other duties as assigned If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Support the continuous improvement of key components of the Quality Management System (QMS) and related standards. Work with QMSO leadership to assess and report on the functioning of components constituting the QMS. Supporting Activities QMSO Support As assigned, complete QMSO goals for the key QMS elements. Maintain a familiarity with Parexel QMS-related applications and related processes. Participate in projects and initiatives as assigned, including reporting information and escalations as needed. Remain informed about developments in relevant regulations and guidelines. Provide technical knowledge where appropriate. Support Operations staff in the use of electronic quality systems; summarize automated quality system reports and provide metrics as appropriate. Support the review of QMS processes. Assist in the maintenance of the relevant website, Parexel Connect page and filing areas, as needed. Parexel Quality Department Support Support Corporate Quality in the preparation for and follow up of internal/external audits and inspections as required. Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates. Maintain a positive, results oriented work environment Communicate in an open, balanced and objective manner. Skills: Excellent interpersonal, verbal and written communication skills Customer focused approach to work A flexible attitude with respect to work assignments and new learning Ability to manage and prioritize tasks efficiently and accurately Willingness to work in a matrix environment and to value the importance of teamwork Understanding of audit/inspection process Ability to lead projects and teams Strong ability to analyze and interpret data Attention to detail and advanced organizational skills Ability to work independently and take ownership of and responsibility for work assigned IT literate - Experience with Microsoft based applications and a general knowledge of PC functions Culturally aware and ability to think and work globally English proficiency (written and oral English) Knowledge and Experience: 2 to 5 years work experience Extensive experience in a Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in the areas of QMS support required Knowledge of Good Practices (GxP) compliance required Project Management / Technology / Business Operations experience, as appropriate, preferred Education: Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred. Master's Degree in a science, technology or industry-related disciple preferred. RequiredPreferredJob Industries Other

QA Specialist II, Cell Therapy - Contract - Philadelphia, PA Proclinical is seeking a highly motivated QA Specialist II to join the Quality Operations team for a night shift role. This position involves ensuring compliance with cGMP regulations and internal policies, working closely with manufacturing personnel to maintain high standards of work. Shifts: Wednesday to Saturday 7pm - 6am (2 roles open) Sunday to Wednesday 7pm - 6am (1 role open) Primary Responsibilities: The successful candidate will act as a key point of contact between manufacturing and Quality teams, ensuring informed decision-making and compliance with release processes and procedures. Skills & Requirements: A bachelor's degree in science, Engineering, or a related technical discipline or equivalent industry experience. At least: 3+ years' experience in a regulated industry. Working knowledge of cGMP regulations. Prior experience and ability to work in an aseptic processing environment. Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint. Attention to detail. Knowledge of QMS systems is a plus. The QA Specialist II, Cell Therapy's responsibilities will be: Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management. Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management. Disposition incoming raw materials Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements Maintain and report on Quality Metrics. Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. Maintain and report on Quality Metrics. Other tasks as assigned. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc. Must meet requirements for and be able to wear a half-face respirator. Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps. Ability to crouch, bend, twist, reach, and perform activities with repetitive motions. Ability to lift 20 lbs. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline Work Environment: Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels. Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors. This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Glendale, CA As a Sr Project Quality & Risk Lead you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients. Responsibilities: Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk signal evaluations for assigned projects using dashboards, reports, metrics and other available tools. Facilitate and support the risk management process for assigned projects using the available tools. Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies. Provide oversight, transparency and tracking of quality issues for assigned studies. Assist with preparations, conduct and response/action plan development for audits/inspections as assigned. Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts. Partner with project teams to achieve and maintain inspection-ready state including story board oversight. Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality Lead. Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested. Maintain compliance with Parexel standards. Mentor PQRLs and EP Quality Specialist as needed. Very good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback. Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions. Very good skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues. Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge. Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus. Advanced ability to manage the complexity of a matrix environment while valuing the importance of teamwork. Skills: Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions High ability to develop professional, collaborative relationships both internally and with the client Strong skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus Ability to travel 10% - 15% Knowledge and Experience: 6+ years' experience in clinical research Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development Expertise with ICH-GCP principles English proficiency (written and oral) Education: Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred. * Master's Degree in a science, technology or industry-related disciple preferred. RequiredPreferredJob Industries Other