Analyst 3 - Quality Assurance
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Job Location:
Titusville, FL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in Titusville NJ is currently looking for a eLIMS Administrator to join their expanding team.
Job Title: eLIMS Administrator / Hybrid Work
Duration: 12 months contract extendable up to 24 Months
Location: Titusville NJ
Our client a world-leading Pharmaceutical Company in Titusville NJ is currently looking for a eLIMS Administrator to join their expanding team.
Job Title: eLIMS Administrator / Hybrid Work
Duration: 12 months contract extendable up to 24 Months
Location: Titusville NJ
Candidates can be local to Titusville NJ; Horsham PA; or Wilson NC (must be able to commute for HYBRID)
Role is HYBRID (3 days onsite)
Role is HYBRID (3 days onsite)
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Notes:
Role is HYBRID (3 days onsite)
Candidates can be local to Titusville NJ; Horsham PA; or Wilson NC (must be able to commute for HYBRID)
NO additional travel needed for this role
Bachelors degree is not required but preferred
Candidates need to be familiar with building a system from the bottom to the top
eLIMS system implementation is the bulk of the role
Need to have experience with automation to help with automation of eLIMS setup
Must have Master Data experience (back-end experience) building the system experience not user experience
Experience with TruVault COMET Confluence
Must have experience with Analytical Testing
Will be working with others in different countries
Will train with a group in India in the mornings
Must be willing to be on camera for meetings
Experience with laboratory systems
Should have 4-6 years of experience
Role is HYBRID (3 days onsite)
Candidates can be local to Titusville NJ; Horsham PA; or Wilson NC (must be able to commute for HYBRID)
NO additional travel needed for this role
Bachelors degree is not required but preferred
Candidates need to be familiar with building a system from the bottom to the top
eLIMS system implementation is the bulk of the role
Need to have experience with automation to help with automation of eLIMS setup
Must have Master Data experience (back-end experience) building the system experience not user experience
Experience with TruVault COMET Confluence
Must have experience with Analytical Testing
Will be working with others in different countries
Will train with a group in India in the mornings
Must be willing to be on camera for meetings
Experience with laboratory systems
Should have 4-6 years of experience
Principle responsibilities:
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 clients Innovative Medicine.
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 clients 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 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.
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
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
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium
