Quality Control Analyst
About The Position
The QC Analyst, Systems specialist, position supports the overall QC organization and is responsible for local systems management in the QC organization and communication with global workgroups within the systems area. This position requires organizational leadership, interpersonal skills, technological savvy, and technical writing skills. This position will work cross-functionally and will drive improvements within a global organizational framework. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Requirements
- A minimum of a Bachelor's Degree in science or equivalent technical field is 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
- 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).
- Experience with LabVantage eLIMS.
Nice To Haves
- Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing
- Ability to independently perform project management functions.
- Experience with electronic systems such as iLAB
Responsibilities
- Support building and approving MasterData as per the local request
- Process LIMS change control requests
- Manage the LIMS change control process through timely resolution of incident tickets.
- Works with the laboratory personnel to optimize LIMS functions for the laboratory
- Coordinate system maintenance downtime needs between user community and system support personnel.
- 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 to track status of LIMS change requests and project status.
- Provides end-to-end support for tickets requiring system change (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution).
- Provide training to new user 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 Health Authority inspections
- 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
Benefits
- Equal Opportunity Employer.
- Consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
- Actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
- Commitment to providing an interview process that is inclusive of our applicants’ needs.
- Accommodation for individuals with disabilities.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
