Quality Assurance Shop Floor Associate II

Quality Assurance Shop Floor Associate II

Location:

Raritan, New Jersey, United States of America

Johnson & Johnson Innovative Medicine invites applications for the Quality Assurance Shop Floor Associate II in a controlled cGMP environment. This role focuses on ensuring the quality and compliance of viral vector production, working closely with internal quality organizations and cross-functional teams.

• Provide oversight and support to clean room activities.
• Serve as QA shop floor support (Grad-B/ISO-7) for extended periods.
• Collaborate with Process Development and Operations to transfer processes to the cGMP facility.
• Support creation, review, and approval of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor.
• Assist with aseptic process simulations to maintain product sterility.
• Conduct real‑time review of all documentation and reporting during process unit operations.
• Investigate non‑conformances, approve findings promptly, and implement corrective/preventive actions.
• Perform quality spot checks and audit trail reviews as required.
• Support material transfer movements.
• Drive compliance to reduce non‑conformances proactively.
• Carry out tasks in line with safety policies, quality systems, and cGMP requirements.
• Monitor warehouse, manufacturing, and support activities for cGMP compliance through spot checks/internal audits.
• Complete additional duties as assigned.

• Education: Minimum bachelor’s degree; preferred in Science, Biology/Biotechnology, Gene Therapy, or related technical field.
• Required experience: Minimum 2 years in QA within pharmaceutical or related industry.
• In-depth knowledge of cGMP regulations and FDA/EU guidelines.
• Highly organized with strong attention to detail and the ability to follow procedures independently.
• Strong interpersonal and verbal communication skills; capable of summarizing and presenting results.

• Experience with aseptic processing in ISO 5 clean room.
• Knowledge of cGMP regulations related to cell‑based product manufacturing and Good Tissue Practices.
• Proficiency with SAP, MES, Track Wise, or equivalent systems.
• Excellent written and verbal communication, conflict management, and multitasking abilities.
• Experience collaborating with stakeholders and cross‑functional teams.

• 8‑hour shifts Monday‑Friday with occasional off‑shift or weekend support.
• Primary location in Raritan, NJ; up to 5% local travel may be required.
• Physical demands include lifting up to 20 lbs, standing or sitting for extended periods in a clean room, and visual inspection of materials.

• Vacation: 120 hours per calendar year
• Sick time: 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington)
• Holiday pay including floating holidays: 13 days per calendar year
• Parental leave: 480 hours within one year of birth/adoption/foster care
• Bereavement leave: 240 hours for immediate family, 40 hours for extended family per year
• Caregiver leave: 80 hours in a 52‑week rolling period (10 days)
• Volunteer leave: 32 hours per calendar year
• Military spouse time‑off: 80 hours per calendar year
• Retirement plan: consolidated pension and 401(k) savings plan (subject to respective plans)

The anticipated base pay range for this position is $65,000.00 - $.

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.

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 may contact us via  Internal employees may contact AskGS to be directed to your accommodation resource.