Location: Allendale, NJ
kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients.
Essential Functions and Responsibilities Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves
the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Attends project kick-off meetings to understand the scope of the project.
Creates, updates, reviews and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc. according to client requirements and project scope. Participates in tech transfer activity to ensure adherence to company quality system standards. Proactively identifies risk and prepares mitigation strategies associated with project and client work. Represents QA Client Services during scheduled meetings with client and cross functional
department. Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.
Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables. Draft initial Quality agreement and complete necessary revisions based on client and company requirements. Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate. Provides quality data to Project Manager for the purpose of creating KPI metrics. Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients.
Updates and maintains accurate information for each client on project-related documentation repository (i. e. Share Point). Communicates internally within QA team to provide key updates on project status, timelines, and deliverables. Formulates and prioritizes appropriate responses to client requests or concerns. Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline. Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis.
Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations. Other duties may be assigned Qualifications Bachelor's Degree in Life Sciences Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred. Experience in authoring, reviewing, and /or approving c GMP/c GTP related documents (Investigation report, CAPA report, SOPs etc. ) required.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Familiar with FDA, ISO, and other regulatory agency guidelines. Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required. Working knowledge and technical understanding of aseptic manufacture of biologics preferred. Experience in both clinical and commercial manufacturing is preferred. Experience participating health authority inspections and/or client audits preferred. Experience in organizing teams for effective and timely completion of projects.
Competencies/Candidate Profile Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect. Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.
Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesnt show frustration when resisted or blocked; is a settling influence in a crisis. Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
Biotechnology Compensation: View salary Total position: 1 Relocation assistance: No Visa : Only US citizens and Greencard holders This position reports to the Quality Assurance Manager.
Responsible to perform Quality Assurance activities in support of Quality Systems and/or client procedures including but not limited to client specific document management, issuance, investigation, CAPA, creating/updating SOPs, Qualification and Validation Reports, etc.
Attends project kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity
is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients. Essential Functions and Responsibilities Below is the summary of the role responsibilities.
This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Attends project kick-off meetings to understand the scope of the project. Creates, updates, reviews
and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc.
according to client requirements and project scope. Participates in tech transfer activity to ensure adherence to company quality system standards. Proactively identifies risk and prepares mitigation strategies associated with project and client work. Represents QA Client Services during scheduled meetings with client and cross functional department. Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.. Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables.
Draft initial Quality agreement and complete necessary revisions based on client and company requirements. Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate. Provides quality data to Project Manager for the purpose of creating KPI metrics. Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients.
Updates and maintains accurate information for each client on project-related documentation repository (i. e. Share Point). Communicates internally within QA team to provide key updates on project status, timelines, and deliverables. Formulates and prioritizes appropriate responses to client requests or concerns. Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline. Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis. Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations.
Other duties may be assigned Qualifications Bachelor's Degree in Life Sciences Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred. Experience in authoring, reviewing, and /or approving c GMP/c GTP related documents (Investigation report, CAPA report, SOPs etc. ) required. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Familiar with FDA, ISO, and other regulatory agency guidelines. Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required. Working knowledge and technical understanding of aseptic manufacture of biologics preferred. Experience in both clinical and commercial manufacturing is preferred. Experience participating health authority inspections and/or client audits preferred. Experience in organizing teams for effective and timely completion of projects. Competencies/Candidate Profile Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.
Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesnt show frustration when resisted or blocked; is a settling influence in a crisis. Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
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
