Johnson & Johnson Innovative Medicine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control (QC) Clinical, Release, and Stability (CRS) Analyst, Systems Specialist! This position will be located in Malvern, Pennsylvania!
At the Johnson & Johnson Innovative Medicine, Inc. of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Johnson & Johnson. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/johnson-johnson-innovative-medicine.com.
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The QC CRS Analyst, Systems Specialist, position supports the QC Clinical, Release, and Stability (CRS) Laboratory, Laboratory Method Executions (LMEs) and is responsible for local systems management in the QC CRS organization, in addition to supporting investigations and quality records, stability programs, and Certificate of analysis (CoA) generation for batch release, as necessary. This position requires organizational leadership, interpersonal skills, understanding of different technology platforms, and technical writing skills. This position will work cross-functionally and will drive improvements within a global organizational framework.
Responsibilities:
- Supports LME generation of eLIMS assay builds.
- Implements LMEs utilizing Site Key User access to eLIMS.
- Maintains, updates, and manages LMEs, as necessary.
- Supports change control requests.
- Supports investigations and other quality records, as necessary.
- Manage eLIMS requests through timely resolution of issues.
- Works with the laboratory personnel to optimize eLIMS functions for the laboratory.
- Coordinate system maintenance downtime needs between user community and system support personnel.
- Support MasterData requests and updates, as per the local procedures.
- Prepare and maintain CoA generation to support batch release.
- Lead and mentor on best practices regarding data integrity.
- Provide first level diagnosis and troubleshooting of incidents to support business users.
- Lead cross-functional meetings for projects, as needed.
- Provides end-to-end support for system updates/troubleshooting (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution).
- Provide training to new users and grant access to system.
- Manage computerized systems administration and user rights.
- Represent the Malvern site in global forums/team meetings as the site key user.
- Support stability programs and sample management, as necessary.
- Support Health Authority inspections and internal audits.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Author, review and approve documents.
- Other duties will be assigned, as necessary.
Qualifications
Education:
A minimum of a Bachelor's Degree in science or equivalent technical field is required.
Required:
- A minimum of two (2) years of experience within a biological and/or pharmaceutical industry or equivalent.
- Experience in a Quality Control setting.
- Skilled in basic and advanced knowledge of LIMS systems.
- Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
- Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing.
- Proficient in performing technical writing.
- Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Preferred:
- Experience with LabVantage eLIMS.
- Ability to independently perform project management functions.
Other:
- May require up to 10% domestic and international travel
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.
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.