QA Incoming Inspection Specialist II (3 openings)

Johnson & Johnson Innovative Medicine; Raritan (NJ); Vor Ort; USD 65.000 - 104.650; Vollzeit

Benefits dieser Stelle

Vacation – 120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per calendar year

Parental Leave – 480 hours within one year

Volunteer Leave – 32 hours per calendar year

Zusammenfassung

A leading healthcare company is looking for a Quality Assurance Incoming Specialist II based in Raritan, NJ. The role involves overseeing the quality and compliance of materials for CAR-T production in a regulated environment. Candidates should have a Bachelor's degree in a relevant field and minimum 2 years of experience in a regulated manufacturing setting. Demonstrated knowledge of cGMP regulations and strong interpersonal skills are essential for success in this dynamic team environment.

Aufgaben

• Responsible for incoming inspection/release of materials related to CAR-T products.
• Review and disposition of all incoming materials per inspection plan.
• Generate inspection reports and ensure thorough investigations of non-conformances.
• Provide Quality Oversight to Warehouse for cGMP compliance.

Kenntnisse

Regulated manufacturing experience

Knowledge of cGMP regulations

Interpersonal communication

Attention to detail

Independence in routine tasks

Ausbildung

Bachelor’s degree in Engineering or Science

Jobbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Raritan, New Jersey, United States of America

Job Description

Johnson & Johnson is currently seeking three Quality Assurance Incoming Specialist II. This position will be located in Raritan, NJ! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Johnson & Johnson Innovative Medicine, 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 releases of materials related to the production of CAR-T and viral vectors in a controlled cGMP 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.

Main Responsibilities Will Include, But Are Not Limited To

• Responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products and viral vectors for clinical trials and commercial operation
• Reviews, inspection, and disposition of all incoming materials for use of CAR-T and viral vector product manufacturing per inspection plan and record results to complete receipt process
• Review inspection documentation (C of A or other Material Certifications) for inbound materials.
• Review and inspect documentation in support of Final Product Shipments
• Generates inspection reports and non-conformances for failures
• Ensures non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented
• Track investigations to ensure timely closure
• Provide Quality Oversight to Warehouse for cGMP compliance through spot checks/internal audits
• Support execution of technical protocols
• Participate in departmental or multi-functional, interdepartmental teams and meetings
• Support External/Internal Audits
• Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance.
• 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.
• Other duties may be assigned as necessary.

Qualifications

Education

• A minimum of a Bachelor’s Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred.

Skills & Experience

• Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) 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 8-hour shifts 1st shift Tuesday-Saturday, and provide occasional off shift or weekend support, as needed.
• This position is located primarily in Raritan, NJ, and may require up to 5% local travel.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Pay Range

$65,000.00 - $104,650.00

Additional Description For Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Benefits

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits