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Car-t Warehouse Process Specialist
4 months ago
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Warehouse Process Specialist
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.
The CAR T Warehouse Support Associate will provide technical expertise to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support for the investigation and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.
**Key Responsibilities**:
- Follow up to resolve if corrective actions adequately addressed root cause of NC event.
- Report and track deviations, events and key process parameters and provides reports to management on trending, and status as requested.
- Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
- Implement process improvements within the change control system.
- Recognize and act on potential compliance issues and opportunities for process changes/continuous improvement.
- Multi-task and prioritize projects with competing deadlines.
- Partner with cross functional teams and warehouse leadership to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Review, edit, and approve SOP and Work Instruction revisions.
**Qualifications**:
**Education**:
- Minimum of Bachelor's degree and/or equivalent degree, required
**Experience and Skills**:
**Required**:
- A minimum 2 years of professional relevant business experience
- Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations.
- Ability to learn and operate various enterprise systems including eLIMS, Comet, SAP.
- Excellent written and oral communication skill
- Experience working in a Manufacturing Warehouse environment
The anticipated base pay range for this position is $ 76,000- $121,900 USD
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. _
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short
- and long-term disability, business accident insurance, and group legal insurance. _
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). _
**_Employees are eligible for the following time off benefits: _**
- _Vacation - up to 120 hours per calendar year _
- _Sick time - up to 40 hours per calendar year _
- _Holiday pay, including Floating Holidays - up to 13 days per calendar year _
- _Work, Personal, and Family Time - up to 40 hours per calendar year _
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
