LIMS Analyst / Administrator
Proclinical is currently recruiting for a LIMS Analyst and Administrator for a multinational pharmaceutical company located in Marietta, PA. Successful candidate will support the implementation/administration/maintenance of a LIMS or LES system. This position is responsible for managing QC processes. They must understand regulations and incorporate into processes.
- SPOC: act as the single point of contact between the business and Tech department
- LIMS/LES Administration: define, create and manage static data in the LIMS/LES to support labs executing their lab activities
- Support to users: provide strong support to system users on a day to day basis, multi-site and/or multi-language (act as the single point of contact between business and Tech; advice users, simulate test cases in inferior environments in order to determine if scenario is relevant for production…).
- IT Incidents: understand problems/issues, determine root cause and assess impact on data and on business, take part to the definition of incident resolution priority based on risk/criticality, ensure proper follow-up and communication to stakeholders.
- Requests for enhancements: identify the different opportunities to enhance the systems that would improve the business efficiency and/or quality (collect and log opportunities, assess impact on business, determine implementation workload and cost, define priority)
- Corrections and enhancements: take active part to the periodic delivery of corrections and enhancements (test the corrections/improvements delivered by the Tech department; draft System Acceptance Test Protocols; create data sets and execute system validation; train users on new functionalities; ensure adequate communication to users)
- Data analysis/cleaning/monitoring: maintain, ensure life cycle management of Master Data ; perform complex analysis/investigations within systems on data to ensure their integrity.
- Periodic Compliance Review: ensure permanent validated state of systems (review and update system documentation, re-execution of validation protocols…)
- Access Management: manage accesses to systems in order to ensure that the right users have the right accesses (user mapping)
- Projects: Take active part to projects and bring expertise of the systems & business processes to improve, deploy or roll-out new functionalities (take active part to blueprint, system informal testing, validation and Go Live phases)
Skills and Requirements:
- BS or BA in Computer Science, Biology or a related scientific discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
Computer Scoence, Biology or a related scientific Degree in other discipline if sufficient technical depth has been achieved from professional experience.
- Relevant experience with LIMS/LES administration (preferably LabWare)
- Minimum of 3 years experience in cGMP-regulated environment.
- Previous experience with validation, calibration, or laboratory equipment/instrument maintenance.
- Affinity with process improvement and optimization
- Significant experience in supporting business system users
- Excellent communication skills
- Participate in cross-functional deviations as needed.
- Must have strong technical writing skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.