Quality Assurance Shop Floor Associate II

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Job Description:

Janssen Pharmaceutical a member of Johnson & Johnsons Family of Companies is recruiting for a Quality Assurance Shop Floor Associate II .This position will be located in Raritan NJ!

At the Janssen Pharmaceutical Companies of Johnson & Johnson we are working to create a world without disease. Transforming lives 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 Janssen Biotech Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech Inc. one of the Janssen Pharmaceutical 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 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.

Are you interested in joining a team that is positively impacting patients lives by ensuring high quality in our pharmaceutical products Apply today for this exciting opportunity!

Responsibilities will include but are not limited to:

• 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 cGMP facility to manufacture products.
• Support creation review or approval of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor.
• Support on aseptic process simulations of the manufacturing 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.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Perform Quality spot checks and Audit trail review as required.
• Support Material transfer movement as required.
• 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 cGMP requirements.
• Monitor warehouse manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits.
• Other duties will be assigned as the need arises.
• Responsibilities will include but are not limited to tasks mentioned above.

Qualifications:

Education:

• Minimum of a bachelors Degree required; focused degree preferred in Science Biology/Biotechnology Cell/Gene Therapy or equivalent technical field.

Skills & Experience:

Required:

• Minimum 2 years of relevant work experience.
• Quality Assurance experience within pharmaceutical or a related industry.
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) 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 cGMP 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 at the same time.
• Familiarity with SAP MES (electronic batch records) TrackWise (quality event management) or equivalent systems.

Other:

• Requires ability and flexibility to work 8-hour shifts Monday - Friday and provide occasional off shift or weekend support as needed.
• This position is located primarily in Raritan NJ and may require up to 5% of local travel.
• Requires the 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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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 . internal employees contact AskGS to be directed to your accommodation resource.

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