Quality Assurance Specialist ||

About the role

Johnson & Johnson is seeking a Quality Assurance Specialist II to join our QA team in Raritan, NJ. The position offers a flexible schedule, with a preference for the Wednesday-Saturday shift.

Responsibilities

• Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
• Contribute to process improvement of batch release and turnaround times to ensure turnaround times and QA batch release deadlines.
• Perform duties/tasks under minimal direction/supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts.
• Ensure readiness of records for regulatory inspections and internal audits.

Qualifications

• Minimum of a Bachelor’s degree in Science, Information Science or equivalent technical discipline is required.
• Minimum of 2 years of experience in Quality Assurance/Quality Systems/Compliance.
• Good written and verbal communications skills.
• Experience working with in large molecules, or CAR-T production.
• Knowledge of International regulatory guidelines, e.g. EU Guidance.

Skills

• Knowledge of cGMP/GTP regulations and FDAG

Benefits

• 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)).
• 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 period, 10 days Volunteer Leave - 32 hours per calendar year, Military Spouse Time-Off - 80 hours per calendar year.