Description
We have an exciting opportunity for an QC Analyst - Laboratory Services to join our expanding team in Cork.
As an QC Analyst - Laboratory Services, your typical day may include:
- Administrate and maintain QC Laboratory systems such as eLIMS, LES, Empower 3, SDMS and Softmax Pro
- Providing day to day operational & training support for laboratory systems
- Completion of necessary software systems documentation reviews including periodic reviews, data integrity reviews and SOP updates.
- Creating and managing Empower projects, user accounts, instrument methods, method sets, report methods and processing templates
- Interacts and represents the Cork site on Global COEs related to laboratory systems.
- Ensure laboratory systems are compliant with the data integrity requirements of all applicable regulatory guidelines
- Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
- Anticipates and plans for future requirements in the area.
- Deals with events/deviations in an accurate and timely manner.
- Identifies opportunities to improve the services provided eg new technologies, improved vendor processes, cost, quality etc.
- Supports QC where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
- Deputizes for the supervisor and other ream members as appropriate.
- Collaborates across multiple lab groups and with other Janssen sites
To be part of this high performing team you will have great attention to detail, alongside
- BSc Hons (or Higher) in a Science or related discipline.
- Experience in a similar role within a laboratory environment
- Excellent social and communication skills
- Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project life cycle and other regulatory requirements or policies
- Self-driven and keeps up to date with regulatory, technical developments within the industry.
- Focus on patients and customers at all times.
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services