Johnson & Johnson Biology Quality Assurance Specialist Vacancy
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! The QA Change Control Specialist II is responsible for assessing change needs, impacts, and partner management activities, as well as supporting organizational change activities.
Job Title: Change Control Specialist II, Quality Assurance CAR-T
Location: Raritan, New Jersey
Department: Quality
Req ID: 2206009520W
Elibgility Criteria
A minimum of a Bachelor’s or equivalent degree in Biology, Engineering, Science, or equivalent technical subject area is required
Experience and Skills:
Required:
- Minimum two (2) years of relevant work experience
- Experience in Quality Assurance, Quality Systems, or Compliance
- Demonstrated experience supporting change controls
- Strong interpersonal, written, and verbal communication skills, and the ability to influence at all levels
- Practical knowledge in current Good Manufacturing Practices
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, and Outlook)
Preferred:
- Experience with CAR-T cell and gene therapy
- Knowledge of National and International manufacturing regulatory requirements (e.g., FDA/EU guidance)
- Familiarity with SAP, MES (electronic batch records), Trackwise (quality event management), or equivalent systems
Other:
Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice
Key Responsibilities:
- Support process changes arising from updates to materials, excipients or finished goods requirements.
- Support and streamline the site change control process.
- Act as change control champion by being responsible for the change control from Initiation through completion.
- Participate in change control meetings.
- Run reports and conduct data analysis to support the establishment and monitoring of change control.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
- Other duties will be assigned, as needed.
Johnson & Johnson Biology
