Location: Newark, NJ
Company: JGM
of design quality plans and procedures for design-build projects of a similar size and scope. This position is 100% on site (EWR Airport in Newark)With us, you get work-life balance with engaging on-site roles and ample time off, opportunities to advance your skillset, and of course, full benefits.
With our medical, dental & vision benefits, along with 401k contribution matching, we're as dedicated to helping you develop as we are in developing our next project. When you work for JGM, you're joining a dynamic group of people working on a diverse portfolio of projects from construction and project management, to engineering, to architecture. We believe in diversity, closing the gender
gap, and compliance (aka employee rights, safety and support). DUTIES Managing the scope, schedule, budget, safety, and quality of multiple rail transit construction and design-build projects from commencement to completion.
Coordinating and scheduling engineering and inspection services, maintaining client and subcontractor relationships, and generating and maintaining project status reports. Reviewing and commenting on design documents, including performing constructability reviews; reviewing and approving reports and construction-phase documentation to ensure compliance with project specifications, drawings, building codes, and all other related regulations and applicable industry
standards. Overseeing and managing a project team. Interfacing with owner management teams and labor resources, and acting as owners representative in all forums.
Reviewing schedules and estimates for accuracy. Participating in change order negotiations (including assisting in the creation of scopes of work and independent estimates); Coordinating and executing contractor access and protection requests including track outages / GOs, foul time, property access requests, flag protection, and force-account labor (i. e. track, signal, power, and other owner-employed disciplinary labor groups); Chair meetings and lead project presentations as owners-representatives.
Reviewing and commenting on all meeting minutes. Review proposals, invoices, requisitions, and purchase orders for processing. As well as all other related duties as assigned. QUALIFICATIONS Must have a minimum of 10 years of relevant management and project leadership experience managing projects and associated staff; any other suitable combination of education, training, or experience is acceptable. Bachelor's Degree in Engineering, Construction Management, Architecture, or Business Management is required. A Valid PE or RA License is required. CCM Certification is highly preferred. Must have experience with, executing design-build and/or construction projects within an operating rail transit system, including general knowledge of rail transit operations; Must have an understanding of the fundamentals of rail industry codes, standards, and requirements, with the ability to comprehend construction plans and documents; Must have excellent oral and written communication skills; with outstanding interpersonal skills; Must be detail-oriented, with the ability to multi-task in a fast-paced environment; Must be willing to work nights and weekends as needed.
May also require a valid, clean driver's license and personal vehicle to travel to the project site.
Experience in Port Authority of NY and NJ (PANYNJ) Projects. Minimum 10 years of relevant work experience Proactive self-starter with a proven ability to work independently and efficiently. Must be able to pass PANYNJ background & and badging. Must be able to commute to EWR Airport. Visit our website at We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status. PDN-9ae3d1ad-66f6-4e34-bd41-265e96452bb6
to stop work. The CQCM shall have demonstrated experience in construction with at least 10 years of experience in quality control activities, including preparation and implementation of quality plans and procedures for design-build projects of a similar size and scope.
This position is 100% on site (EWR Airport in Newark)With us, you get work-life balance with engaging on-site roles and ample time off, opportunities to advance your skillset, and of course, full benefits. With our medical, dental & vision benefits, along with 401k contribution matching, we're as dedicated to helping you develop as we are in developing our next project. When you work for JGM, you're joining a dynamic group
of people working on a diverse portfolio of projects from construction and project management, to engineering, to architecture. We believe in diversity, closing the gender gap, and compliance (aka employee rights, safety and support).
Duties: Develop and implement project-specific quality control. Inspect and evaluate the work area by plans, specifications, and contract documents, reporting deficiencies as appropriate and elevating issues as needed to ensure safe work practices and quality Develop, gather, maintain, and/or submit work plans, submittals, reports, etc. Ensure that subcontractors are aware of all project quality control. Plan for and conduct a three-phase inspection program
to include: Preparatory Meetings and Reports; Initial Phase Inspections and Reports; Follow-up Inspections and Reports; and Final Phase Inspections and Lead and document quality control meetings with the project team and/or customers, and provide written minutes.
Provide daily quality control reports to achieve desired quality outcomes promptly by reinforcing activities that are being constructed in conformance with project-specific standards, and constructively confront non-conformance Verify and document that all materials/equipment received for the project are in conformance with the approved submittal, are handled and stored appropriately, and are acceptable for use in the project; check for damaged and defective materials and address Schedule, coordinate, and document all required code and independent inspections.
Clearly document, correct, and re-inspect all non-conformances before covering up work. Review the as-built drawings to ensure that they are current and that deviations from the contract drawings are Review the Job Site Safety Plan, verify that a hazard analysis has been approved before the performance of a specific feature of work during the preparatory phase of control, verify that safety measures are in place during the initial phase of control, and conduct safety inspections during the follow-up phase of control.
Stop work; reject materials and/or equipment; and direct the removal and replacement of any work not in compliance with contract documents, applicable codes, building standards, and/or established principles of construction engineering, or activities that present life-threatening conditions or damage to the site. Communicate and interact as a team member with all trades, manufacturers, suppliers, construction staff, and customer representatives, in a professional Minimum Requirements: Bachelor's degree in construction management, construction science, engineering, or related field from an accredited university preferred.
Minimum of 10 years experience in programs of similar size and scope. Current OSHA 30; First Aid/CPR; and Construction Quality Control Management certifications; or ability to obtain within 30 days of hire Exceptional communication skills (written and verbal); and ability to interact professionally with customers, coworkers, and subcontractors. Exceptional organizational and time management skills Proficient with Microsoft Office (Outlook, Excel, Word, Power Point, etc. ) and Procore.
Experience in performing, monitoring, and reviewing planning and scheduling functions, which include schedule development, control, and analysis, in the field and the home office. Skilled in oral and written communication. Advanced level of knowledge of engineering, procurement, contracts, construction, and startup work processes, as performed by Bechtel. Knowledge of engineering and construction management customarily acquired over time through specialized instruction or practical experience. Demonstrated ability to plan, organize, direct, perform, review, and present scheduled products independently with minimal supervision.
This includes using a high level of professional judgment and knowledge related to technical planning and scheduling skills and engineering design, construction, and procurement practices. Experience on major lump sum projects with a direct-hire construction strategy is preferred. Experience in Port Authority of NY and NJ (PANYNJ) Projects. Minimum 10 years of relevant work experience Proactive self-starter with a proven ability to work independently and efficiently. Must be able to pass PANYNJ background & and badging. Must be able to commute to EWR Airport.
Visit our website at We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status. PDN-9ae3d1ad-460b-4586-8bda-02cbeb6a7b69
various quality continuous improvement activities. Duties & responsibilities. Work in concert with QMS Lead to: Develop and maintain quality programs, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Lead audit and inspection preparation, resolution of audit and inspection
findings and liaises with auditing groups and inspectors through all stages of the audits. Prepare reports and/or necessary documentation (ex Corrective Action Reports) and provides to applicable stakeholders, both internal and external.
Ensure the quality assurance programs and policies are maintained and modified regularly. Management and facilitation of quality documentation system. Candidate must be a self starter, proactive and have good communication skills to support interactions occurring before, during and post audits. Requirements: At least 10 years of expereince. Bachelor's Degree in Computer Science, Electrical Engineering or Information Systems or related field. 5 years of
relevant experience may be substituted for the Bachelor's Degree.
Master's Degree or MBA in related field may be substituted for Bachelor's degree and 3 years experience. Ph D in related field may be substituted for Bachelor's degree and 7 years experience" Job Posted by Applicant Pro
by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc.
is part of the Janssen medical Companies. Janssen Biotech, Inc. one of the Janssen medical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance
the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our medical products?
Apply today for this exciting opportunity! The QASF Associate II is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled c GMP cleanroom environment. Key Responsibilities: • Provide Oversight and Support to clean room activities. • Provider QA shop floor support (Grad-B/ISO-7) for extended periods of time. • Work with Process Development team and Operations organization to successfully
transfer process to c GMP facility to manufacture products. • Support drafting of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor. • Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised. • Real time review of all documentation and reporting in support of process unit operations. • Support material release in SAP for In-house reagents. • Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented. • Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. • Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival • Monitor warehouse, manufacturing, and manufacturing support activities for CG MP compliance through spot checks/internal audits. • Other duties will be assigned, as the need arises. • Support the Shop Floor Order review and Closure process for executed batches and In House reagents/intermediates.
• Responsibilities will include but not limited to tasks mentioned above. Education: Minimum of a bachelor's or equivalent University Degree required; focused degree preferred in Science, Biology/Biotechnology, Cell/Gene Therapy, or equivalent technical field. Required: • Minimum 2 years of relevant work experience. • Quality Assurance experience within medical or a related industry. • Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidelines. • Highly organized, with demonstrated attention to detail and ability to follow the procedures with minimal direction.
• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment. • Proficient verbal communication skills, with the ability to optimally summarize and present results. Preferred: • Experience with aseptic processing in ISO 5 clean room. • Knowledge of c GMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. • Good written and verbal communication skills are required. • Ability to summarize and present results, and experience with team-based collaborations is a must.
• Ability to collaborate well with stakeholders, customers, and peers. • Ability to manage conflict and issues that arise with internal or external customers. • Ability to handle multiple tasks on same time. • Familiarity with SAP, MES (electronic batch records), Track Wise (quality event management), or equivalent systems. Other: Requires ability and flexibility to work 10-hour shifts between the operational hours of 7:30 AM - 6:00 PM/2:00PM-12:30 AM (Sunday-Wednesday/ Wednesday - Saturday), and provide occasional support including nights, weekends, or other shifts with little or no prior notice.
This position has an estimated annual salary of 61,000- 110,000. Requiresthe ability to meet the physical demands (lift to 20 lbs. stand or sit for extended periods of time in a clean room environment), to perform visual inspections of materials (color, appearance, particles, etc. ) and to document observations during manufacturing. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc. is part of the Janssen medical Companies.
Janssen Biotech, Inc. one of the Janssen medical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational
treatment. In this role, you will be providing quality oversight for daily activities related to the production of cryopreservation of human apheresis and testing of viral vectors in a controlled c GMP environment.
You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our medical products? Apply today for this exciting opportunity! Main Responsibilities will include, but are not limited to: Partner with Operations teams
to support production activities related Advanced Therapy products in a c GMP manufacturing facility.
Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Support change management processes including formal change controls by evaluating the proposed changes, backssing impact, and providing quality input on implementation plans. Author and revise Quality departmental documents. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.
Participate in continuous improvement activities. Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment. Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts. Other duties may be assigned as necessary. Education: A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred. Skills & Experience: Required: Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or medical industry, is required.
Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidance Ability to be organized and capable of working in a team environment with a positive demeanor. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills. Ability to work independently on routine tasks. Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferred: Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred. Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred. Other: Requires ability and flexibility to work 10-hour shifts 2nd shift. Work Tues-Fri 2nd shift (10 hours) one week, Work Wed-Sat 2nd shift (10 hours) other week, and repeat and provide occasional off shift support, as needed. This position is located primarily in Raritan, NJ, and may require up to 5% local travel.
The anticipated base pay range for this position is $60,000 to $96,600 Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. #CAR-T
the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n medicals, LLC is part of the Janssen medical Companies. The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories.
The responsibility includes reviewing and approving, of standard operating procedures (SOPs)/ Forms, validation/ qualification/ method transfer protocols/ reports, completed assay data for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products tested in QC labs which includes In Process, Release, Critical Reagents
and Microbiology labs, Monthly Lab audits, initial approval for retest for SST/AAC/ SAC failures. Closure of QIs related to SST/AAC/ SAC. Key Responsibilities: Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with J&J policies, standards, procedures, and Global c GMP.
Work with QC organization to support the successful transfer of QC Lab functions to the Raritan c GMP facility to test products. Review and approve Technical Documents, Investigational Reports, Completed Daily Assay Data, Personnel Gowning and Pipette Qualifications, Data Generated Reports and Co A's as
applicable. Support the release of patient sample materials. Provide Quality feedback to QC Management by performing spot-checks in the QC Laboratories to ensure compliance.
Strive to reduce non-conformances in supported areas by proactively driving compliance. Strengthen QC Culture and recognize patterns/trends in Shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities. Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities. Routinely recognize and resolve quality issues. Seeks management perspective on quality issues.
Act as liaison for the quality team to guide and improve site improvement projects and strategies. Learn and develop within the business as a Subject Matter Expert on quality assurance topics. Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. Education: Minimum of a Bachelor's Degree required; focused degree in Science or Engineering Technologies preferred Experience and Skills: Required: A minimum of 4 years relevant work experience is required. Knowledge of Gx P regulations and FDA/EU guidance related to manufacturing of biomedicals.
Ability to quickly process information and make critical decisions with minimal oversight. Ability to independently be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive approach under some supervision. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Ability to identify/remediate gaps in processes or systems. Experience with cell and/or gene therapy analytical technique (e.
g. flow cytometry, q PCR) Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). Ability to work with others in a team environment and strong interpersonal and written/oral communication skills. Preferred: Experienced in c GMP aseptic manufacturing environments, preferably in quality control, quality assurance, manufacturing, compliance, clinical quality, or cell and gene therapy Detailed knowledge and understanding of current Good Manufacturing Practices (c GMP). Knowledge of current Good Tissue Practices (c GTP) related to CAR-T manufacturing or cell processing Detailed knowledge of CAR-T QC test methods and related equipment is helpful.
Proficient in applying process excellence tools and methodologies (Six Sigma), such as MES, SAP, PAS-X or similar. Other: Requires ability and flexibility to work 8-hour shifts between the operational hours of 8:00 AM - 5:00 PM Monday - Friday, and provide occasional support including nights, weekends, or other shifts with little or no prior notice This position is anticipated to have up to 10% travel The salary for this position is anticipated to be between $75,000 - $110,000.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. #car-t
