Quality Assurance Shop Floor Associate II

Johnson & Johnson•Raritan, NJ

10d•$65,000 - $104,650•Onsite

About The Position

Janssen Pharmaceutical, a member of Johnson & Johnson's 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 www.Janssen.com and follow us@JanssenGlobal. 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!

Requirements

Minimum of a bachelor’s Degree required; focused degree preferred in Science, Biology/Biotechnology, Cell/Gene Therapy, or equivalent technical field.
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.
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.

Nice To Haves

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.

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 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.

Benefits

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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year