Analyst 3 - Quality Assurance
Analyst 3 - Quality Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
This position works within the eLIMS CoE and is an expert in data setups in the eLIMS system to support lab processes including paperless product release and CofA generations. Additionally this position will support an implementation of the LIMS LabVantage (eLIMS) system at a new plant based in North Carolina as part of Johnson and Johnson Innovative Medicine. This position independently maintains and reviews high quality data setups integrates instruments and applications and translates specifications within the eLIMS system using current business processes. This position reviews and tests system updates creates and manages any system related documents and identifies and drives process improvements. This position is able to interact with IT and speaks business language to customers.
This position takes ownership by completing any incoming requests in a timely order to maintain high quality data. This position is expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.
This position is responsible and able to lead projects within QC Operations e.g. implementation of paperless processes harmonization / standardization of processes. Candidate to work with multiple stakeholders to provide input and ensure end to end set up of eLIMS master data to support implementation.
Maintains system related documentation (procedures events etc) with the appropriate applications (TruVault COMET Confluence q-Test or any other designed system;
Qualifications
A minimum bachelors degree or equivalent education is required. A minimum of 4 6 years of working experience in a regulated medical industry (Pharmaceutical Medical Devices or Diagnostics) with knowledge and experience with LIMS and Quality Systems is required. Extensive other experience with analytical testing quality control or IT is preferred.
Ability to manage multiple issues organize activities prioritize and escalate to management when appropriate. Broad knowledge and experience with cGMPs applicable regulations (e.g. FDA ICH Q8 9 10) and risk management.
Demonstrated strong written and verbal communication skills (Basic in English B2) and the ability to develop and provide training to colleagues and partners.
Demonstrates flexibility in adapting to urgent needs. Ability to interact with local lab leaders on master data related issues as needed and maintain a strong relationship with local laboratories. Maintain a clear line of communication with the eLIMS CoE lead. High level commitment to meeting customer expectations as determined by the eLIMS CoE lead.
Up to 5% Travel required
Primary Location
New Jersey North Carolina Pennsylvania
Other Locations
United States
Additional Details
- Solution & Requisition Sourcing Type : Vendor NeutralSourced
- Reason for Request : Open Position
- Critical Position : No
- Is this position safety sensitive : No
- Will this position require the handling of a controlled substance : No
Employment Type
Full-time
Key Skills
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