Location: Cranbury, NJ
Company: The Judge Group
of the agency meet the standard and are error free. Job Duties: The principal responsibility of quality assurance personnel is to make sure quality of the services provided by APluscare is at the highest level. Quality assurance employees must review the business statistics and then determine areas requiring enhancement.
A quality assurance employee should also inspect the samples and formulate policies concerning improvement of the present quality standards. Personnel should ensure that the services take place in accordance with the standards established. Additional responsibilities include all other duties as assigned by APluscare. The Quality Assurance Coordinator is required to: Oversee
and ensure agency's compliance with DDD regulations at all levels of operations. Demonstrate broad knowledge of New Jersey Division of Developmental Disabilities (DDD) and Department of Human Services (DHS) licensing standards, regulations, and circulars.
Maintain agency's residential/other programs compliance with DDD, DHS, Medicaid, and other applicable state and federal regulations. Cooperate and coordinate with state and other relevant officials during investigations of incidents that involve APluscare and/or its personnel. Ensure agency's compliance with applicable federal and state laws, regulations, and licensing requirements. Ensure agency's compliance with applicable accrediting
bodies. Suggest and participate in policy and procedure development, modification, renewal, as well as adherence while maintaining compliance with applicable requirements.
Provide weekly training and In-service to all staff involved in providing services and supports to clients of APluscare. Conduct weekly visits and audits of all DDD licensed programs in order to maintain continuous compliance with DDD licensing standards. Identify program deficiencies for all residential programs on a weekly basis and supervise program staff as needed to correct deficiencies. Maintain DDD licensure renewal for all agency programs that are licensed by the division. Maintains all company vehicles including registration, insurance, preventative maintenance, repairs, and equipment inventory according to APluscare policies and licensing standards.
Maintains all licenses/certificates for each APluscare program and prepares homes on a regular basis and for licensing inspections. Prepare new programs for initial DDD licensing inspection and secure licensure. Maintain continuous program integrity for all agency programs through quality assurance surveys and reviews. Track and report on quality-related indicators, including areas of risk management and compliance. Conduct weekly quality assurance surveys for all DDD licensed programs Maintain agency compliance with all local, state, and federal regulations for all agency programs Conduct monthly visits and audits of all residential and other programs Prepare and submit program integrity and quality assurance weekly report to the Executive Director Identify program deficiencies for all residential and other programs on a monthly basis and supervise program staff as needed to correct deficiencies All other duties as assigned by APluscare Qualifications: The Quality Assurance Coordinator is expected to posse s excellent interpersonal skills, including the ability to communicate effectively with in individuals with intellectual and developmental disabilities and their families, colleagues, and other parties as necessary for employment with APluscare.
Outstanding negotiation skills, customer-oriented approach, excellent analytical skills, effective leadership capability to lead projects, fundamental knowledge of operational software and understanding concerning concepts, equipment and various other quality management techniques. Employee must cooperate with the officer of licensing and/or any department of Human Service staff in any inspection or investigation Employee must successfully complete and demonstrate proficiency in all areas of required training.
Valid Driver's License Must be at least 18 years of age Physical Demands/Working Conditions: Handles detailed, basic to complex, and specialized concepts and problems, balancing multiple tasks simultaneously. The ability to effectively communicate (orally and written) and interact with others, including diverse, interdisciplinary, cross-functional teams The ability to read, concentrate and learn Physical requirements include sitting, standing, walking, and computer work for long periods of time Pushing, pulling, and lifting up to 50lbs Driving and travel locally and between agency sites and other required locations Support and maintain all corporate policies, procedures, and quality and confidentiality standards Duties and responsibilities may be added, deleted or changed to meet the needs of the organization
systems and monitoring programs to assure continuous quality improvement. The candidate must be familiar with DDD licensing regulations. The Quality Assurance Specialist will complete audits in the residential programs to ensure accuracy and compliance with DDD standards and regulations.
This shall include monitoring of fiscal, medical and ISP documentation to ensure accuracy. The Quality Assurance Specialist will assist the Director of Quality Assurance with new program development and according to funding source guidelines and standards. The QA Specialist will be responsible to conduct training courses during new hire orientation. The candidate must be able to work on numerous simultaneous
projects to meet established timelines and must also be detail oriented. We offer a competitive compensation and benefits package. The position will require you work both in the office and in the field.
Pushing, pulling, and lifting up to 50lbs. Required education: Associates Degree in the social sciences or equivalent. Required experience: 1 year Job Type: Full-time Benefits: Comprehensive benefits package with a choice of health plans that include medical, dental, vision, Life-insurance, a 401(k) investment package along with paid time off for all full-time/Part-time positions
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
