What are the responsibilities and job description for the Specialist 4 - Quality - Research and Development position at jnj?
Johnson & Johnson Family of Companies
Title: Quality Specialist
Location: Titusville, NJ
Duration: 5 months
Pay Rate: $68.57
Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits
Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.
Summary:
In this position you will provide end to end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.
Responsibilities:
- Support the EQ remediation plan at external manufacturer
- Act as PIP (Person-In-Plant) at the external manufacturer
- Provide quality and technical support to ensure effective execution of quality systems at external manufacturing site.
- Support the identification and resolution of quality issues and complaints.
- Monitor quality performance to identify risks and drive implementation of mitigation plans.
- Build relationships with internal and external partners to meet patient supply requirements.
- Influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.
- Collaborate with external manufacturers to support health authority inspection and audit actions; monitor and follow-up on commitments.
- Partner with external manufacturer to define the quality strategy through benchmarking and knowledge sharing.
- Lead risk management initiatives necessary to improve performance.
- Other related activities as assigned.
Qualifications:
- A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.
- A minimum of 4 years working in an FDA regulated environment is required.
- Experience with quality support of clinical and/or commercial manufacturing operations.
- Experience managing quality oversight for pharmaceutical production.
- Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
- Ability to work independently in support of a portfolio of products and suppliers.
- Ability to quickly process complex information and make critical decisions with limited information.
- Experience working on cross-functional project teams.
- Strong communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization.
- Experience working with external partners.
- Experience with product transfer, new product introduction, medical devices, combination products, and advanced therapies.
- Proficient in applying process excellence tools and methodologies.
Salary : $69
