Sr Qa Specialist Jsc Nc_Capa

at J&J Family of Companies in Boise, Idaho, United States

Sr QA Specialist JSC NC\_CAPA - 2406173835W

Description

Janssen Supply Chain (JSC) Global Quality Operations, a member of Johnson & Johnson's family of Companies, is recruiting for a Sr QA Specialist JSC NC\_CAPA ! This position will be fully remote in the United States. The following locations in Europe will also be considered: Leiden, Netherlands; Schaffhausen, Switzerland; Latina, Italy; Cork, Ireland; Beerse, Belgium.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good, and we strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment in reach of everyone, everywhere.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!

In this role the Sr QA Specialist JSC NC\_CAPA is responsible to support global improvements to investigation and corrective and preventive action (CAPA) process and platform across Janssen, driving excellence in NC/CAPA processes and execution. Also, this role will be working with site NC/CAPA business process owners to sustain the NC/CAPA processes in support of all JSC sites and functions.

Key Responsibilities:

+ Support an efficient and effective investigation training/certification. Support NC/CAPA system and process user training.

+ Evaluate Quality Investigation and Corrective Actions and Preventive Actions (CAPA) records to monitor the overall health and quality of the JSC NC/CAPA process execution and compliance to standards and requirements.

+ Participate in site level CRB as an adhoc member delegate.

+ Ensure that the JSC NC/CAPA process is in an Inspection ready state and support audits/inspections as required.

+ Escalate compliance issues or risks associated to the NC CAPA process to the Senior Manager Quality Systems CAPA.

+ Coordinate with JSC sites to ensure actions are completed by responsible functions within a timely manner.

+ Collaborate with J&J Quality Systems Platform Governance and other functions on the enhancement requests to support configurating an automating systems for investigation and CAPA Management to enable process improvements.

+ Reports metrics that are indicative of the process health and overall compliance of the investigation and CAPA system.

Qualifications

Education:

BS/BE in Chemistry, Biology, BioChemistry, Microbiology, Engineering, Mathematics or related science with at least 6 years of experience in conducting and/or leading nonconformance and CAPA activities in a quality regulated environment and related areas in the pharmaceutical industry.

Experience and Skills:

Required:

+ A minimum of 6 years of related experience in the pharmaceutical/medical device regulated industry.

+ Must be able to effectively work in a highly matrixed organization, working across a global organization to support alignment.

+ High degree of interdependent partnering, influencing, and team work.

+ Ability to support multiple projects and priorities to remain effective and focused on business critical objectives.

+ Strong collaboration and communication skills.

+ High level of understanding of industry expectations for nonconformance, root cause analysis, corrective and prevent actions (end-to-end CAPA process).

+ High understanding of cGMP, Good Documentation Practices, and Regulations. Familiarity with US and International GMPs for pharmaceuticals.

+ Ability to apply statistical techniques to track and analyze process performance and trend

+ Good analytical skills, strong problem solving and decision-making abilities.

Preferred:

+ Knowledge in Comet, TruVault, SAP, and Empower Data Acquisition systems.

Other:

+ Requires up to 10% travel

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

The anticipated base pay range for this position is $90,000- $144,900. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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.

Primary Location NA-US-Pennsylvania-Horsham

Other Locations Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America, Europe/Middle East/Africa-Ireland-Cork-Cork

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function Quality Assurance

Req ID: 2406173835W