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
Digital Workplace Architecture Governance across infrastructure domains (Security, Network, Operations & Support, Hosting). The employer permits the employee in this role to work remotely from their residence 2-3 days a week so long as that is with normal commuting distance or within the same metropolitan statistical area.
Send CV/resume and salary requirements to Refer to code "1660" EOE, no agencies please. Sanofi US Services and its U. S. affiliates are Equal Opportunity and Affirmative Action employers.
phone etiquette, and regulations, necessary for success in their positions. In addition, this role collaborates with operational managers to identify process gaps and lead the implementation of improvements focusing on improving systems and processes. Will play an active role in the implementation of policies and procedures for the contact center, ensuring compliance to all pertinent company, local, state and federal regulations and requirements.
The Training Specialist will ensure a service oriented and professional working environment where all patient and customer needs are met. Lastly, the Training Specialist will support Sales Training with the Field Sales Force's responsibilities
where necessary. Key Responsibilities: Contact Center Training Works collaboratively with operations managers to develop an integrated learning and development strategy for all team members.
Spearheads the design and development of training for all contact center staff, including new-hire training related to contact center skills and systems, continuing education and refresher trainings. Leads the creation and maintenance of all training materials including presentations, handouts, videos, and other documents used in the training program. Recommends appropriate learning solutions for representatives and managers of the contact center including mentoring, coaching, classroom, e-learning,
workshops, etc. Communicates trainee performance to operational managers.
Stays abreast of new workflows and learns new systems used at the contact center to deliver training that shares expertise, as well as inspire and motivates employees. Process Improvement Reviews and analyzes Brand Direct Health's operational needs; confers with users to evaluate requirements; discusses solutions and collaborates to develop plan of approach. Through regular and ongoing systems use and testing, identifies, documents, and escalates issues related to processes and performance and works towards resolution. Oversee continuous improvement initiatives and implementation of new processes and technologies.
Analyzes and identifies gaps to target metrics and proposes solutions for improvement. Supports development of written documentation of workflows and policies and procedures. Supports with the implementation of the HIPAA Security and Privacy Program. Participate in Management meetings and collaborate with peers to improve quality and processes along with any necessary training. Identify gaps in efficiencies, document, create workflows to close the gaps and ultimately lead the implementation of improved business processes. Serves as project manager on different contact center projects as assigned Recommend SOP changes to improve business efficiency and positive fill/refill results Other responsibilities Supports departmental and business unit operations by performing other duties as assigned, inside or outside scope of responsibility.
Periodically contributes to call representative reviews. Responsible for driving the Brand Direct Health (BDH) culture through values and customer service standards. Accountable for outstanding patient service to all internal and external customers. When needed, perform the function of the call center agents When able, support the Sales Training Team with Field Sales Force education needs Experience & Qualifications: Bachelor's Degree preferred (in lieu of degree: high school diploma and 5 years relatable experience preferably in a contact center setting).
Proven minimum five years of experience in a contact center environment with increased responsibility and focus on Training, QA and/or PI. Knowledge of customer service principles and practices, technology and performance metrics. Strong evaluator of effective teaching methodologies and tools; keep abreast of new techniques in adult learning.
Competent in teaching processes and systems to adults effectively. Strong skills in customer service, continuous quality improvement, relationship development, team building and employee motivation. Excellent work ethic; ability to prioritize tasks, meet deadlines and work independently in a fast paced environment while managing stress effectively. Strong communication, both oral and written; great presentation skills and interpersonal skills. Proficient in Microsoft Office applications: Power Point, Word, Visio and Excel. Experience with Microsoft 365 is a plus. Ability to maintain a positive, engaged attitude with trainees at all times.
Passionate about making a difference. Strong analytical and software skills. WHO WE ARE: Alfasigma USA is the local affiliate of the Italian based medical company, Alfasigma. Alfasigma is a leading Italian medical company focused on prescription drugs, over-the counter (OTC) and nutraceutical products and has a presence in 90 countries. Alfasigma USA's main goals are to improve the health and quality of life of patients by finding solutions to treat specific patient populations, expand our existing portfolio and bring new products into the US market.
We strive to be a strong healthy company in a strong healthy world. Alfasigma USA is headquartered in Bedminster, NJ. with a manufacturing plant in Shreveport, LA. a remote mail order shop call center and an established national salesforce. Alfasigma USA, Inc. offers: Comprehensive Compensation Package: Competitive base salary, depends on experience Annual bonus potential Comprehensive Benefits Package: Medical, Dental, 401K, Paid Time Off, and Tuition Reimbursement (etc. ) are some examples New hires are eligible for medical and dental coverage on date of hire. Alfasigma USA, Inc.
and its subsidiary, Brand Direct Health, L. L. C. (collectively the " Company" ) is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee on the basis of race, religious creed, religious observance, color, age, interaction, interactionual orientation, gender, gender identity, gender expression, genetic information, national origin, ancestry, marital status, medical condition as defined by state law (cancer and genetic characteristics), disability, military service, military and veteran status, pregnancy, childbirth and related medical conditions, or any other classification protected by federal, state, and local laws and ordinances.
Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please email Human Resources at xyz X@ if you need assistance completing any forms or to otherwise participate in the application process.
patients all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity! Position Overview: Design, perform, and interpret experiments, with moderate supervision, to support analytical development objectives as part of a custom process analytics team.
Ensure smooth day-to-day operation of the analytical laboratory. Responsibilities: Provide analytical support for process development and characterization groups With moderate supervision, design and execute/implement analytical experiments of moderate complexity May conduct experiments/analysis independently and may assist other scientists/analysts with experiments employing various methodologies, including:
cell culture, flow cytometry, PCR, ELISA, MSD, Luminex etc. Apply fundamental scientific knowledge to projects and problems in a positive manner. Perform data analysis and summarize experimental results Interact with QC and Process Development teams to advance analytical projects.
Organize, record and maintain experimental data Convey data analysis and interpretation to supervisor and colleagues with clarity and high level of accuracy Ensure proper operation and perform routine maintenance of all laboratory equipment Assist other staff to complete all laboratory tasks as necessary Document/review laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance
with GLP/GDP requirements Train new members of department in basic flow cytometry techniques and instrumentation.
Maintain a safe workplace in accordance with company and OSHA policies/procedures Qualifications: B. S. in Biology or related discipline with 1 - 4 years of relevant experience Must have excellent organization skills and ability to handle multiple tasks Highly motivated, willingness to acquire new skills and ability to work with minimal supervision Must have strong scientific knowledge appropriate for analytical development work Experience in diverse analytical techniques (ELISA, flow cytometry, PCR) would be advantageous Experience working in a regulated environment would be advantageous Excellent verbal and written communication skills If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If interested, you may contact: Jane Bautista xyz X@ 332206xyz X Jane Bautista Linked In Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, interaction, interactionual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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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.
renewal retention, service and producer/client management. The branch is responsible for commercial U. S. policies which are part of an overall account managed on behalf of Chubb's international zones. The UA gathers and analyzes account-specific information (including but not limited to loss information, exposures, financials, loss control reports) and prepares a risk report for referral to the Underwriter; corresponds with both local U.
S. producers and overseas underwriters to compile necessary information; develops information and recommendations based upon the account review; determines strategy in conjunction with the underwriter; handles all coordination of accounts being sent
to the Processing Center and completes all rating and issuance instructions including appropriate forms, coverages and final premium; ensures electronic file integrity; ensures internal and external service standards are met to achieve a high level of customer satisfaction.
This position may be assigned renewal underwriting authority. Roles/Responsibilities Reviews submission information with the underwriter, researches and provides analysis of account information, and ensures overall regulatory compliance. Compiles and documents the risk report and underwriting strategy Coordinates account processing and servicing Coordinates the quoting, booking and issuance process with the CSR
and completes the risk report for referral to the Underwriter Reviews, verifies and publishes all documents in the electronic customer file Researches and responds to Producer and Overseas Underwriter inquiries Serves as the first point of contact for internal and external contacts on account-related matters Ensures MAX and other tracking systems are updated timely The pay range for the role is $37,500 to $66,500.
The specific offer will depend on an applicant's skills and other factors. This role may also be eligible to participate in a discretionary annual incentive program. Chubb offers a comprehensive benefits package, more details on which can be found on our careers website.
The disclosed pay range estimate may be adjusted for the applicable geographic differential for the location in which the position is filled. QUALIFICATIONS MINIMUM ABOUT US Chubb is the world's largest publicly traded property and casualty insurer. With operations in 54 countries, Chubb provides commercial and personal property and casualty insurance, personal accident and supplemental health insurance, reinsurance, and life insurance to a diverse group of clients. The company is distinguished by its extensive product and service offerings, broad distribution capabilities, exceptional financial strength, underwriting excellence, superior claims handling expertise and local operations globally.
At Chubb, we are committed to equal employment opportunity and compliance with all laws and regulations pertaining to it. Our policy is to provide employment, training, compensation, promotion, and other conditions or opportunities of employment, without regard to race, color, religious creed, interaction, gender, gender identity, gender expression, interactionual orientation, marital status, national origin, ancestry, mental and physical disability, medical condition, genetic information, military and veteran status, age, and pregnancy or any other characteristic protected by law.
Performance and qualifications are the only basis upon which we hire, assign, promote, compensate, develop and retain employees. Chubb prohibits all unlawful discrimination, harassment and retaliation against any individual who reports discrimination or harassment.
of high-quality outcomes and a better experience for patients and providers, all at a lower total cost of care. As part of Optum, we participate in an integrated care delivery system that enables us to support our partners as they navigate a complex healthcare environment, Only SCA Health has a dynamic group of physician-driven, specialty care businesses that allows us to customize solutions, no matter the need or challenge: We connect patients to physicians in new and differentiated ways as part of Optum and with our new Specialty Management Solutions business.
We have pioneered a physician-led, multi-site model of practice solutions that restores physician agency by aligning incentives
to support growth and transition to value-based care. We lead the industry in value-based payment solutions through our Global 1 bundled payment convener, that provides easy predictable billing to patients.
We help physicians address everything beyond surgical procedures, including anesthesia and ancillary service lines. The new SCA Health represents who we are today and where we are going-and the growing career opportunities for YOU. Responsibilities We are actively hiring for an Registered Nurse (RN) Operating Room. Promote the mission, vision, and values of SCA backss patient status throughout the perioperative episode of care. Develop an individualized perioperative patient plan of
care. Serve as a member of a multidisciplinary team in planning perioperative patient care.
Qualifications Graduate of an accredited school of nursing.1 year previous OR experience required Current state nursing licensure to practice in good standings. Successful completion of Basic Life Support (BLS) within 90 of employment or documentation of current BLS certification. Successful completion of Advanced Cardiovascular Life Support (ACLS) Course within 90 days of employment or documentation of current ACLS certification. Successful completion of Pediatric Advance Life support (PALS) course is required when pediatric care is included in the facility scope of services within 90 days of employment or documentation of current PALS certification.
Specialty certification in Perioperative Nursing is preferred. USD $46.00/Hr. USD $55.00/Hr. For more details: jobs-search. org/information-technology_basking-ridge-c438957/rn-operating-room-franklin-surgery-center-basking-ridge_i1959777795
