Posted: 09/28/20222022-09-282022-10-29Employment Type:Direct Hire/PermJob Category:LIMSJob Number: 511193Is job remote?: NoCountry: United States
Job Description
LIMS Analyst & SME – (Full-time) – Onsite – TX
A leading global manufacturing organization in the biopharmaceutical industry has an urgent need for an onsite LIMS Analyst & SME to function as the lead internal customer facing LIMS expert and manage the configuration and implementation of an upgrade from a paper Labware system to an electronic eQMS (Labware 8). As the client enters the integration stage of the project, this full-time role will require someone with direct LIMS implementation experience (Labware preferred) and a good knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements. This opportunity offers excellent benefits starting day 1, relocation assistance and an opportunity to fast-track into a management role very quickly. A more flexible hybrid\remote schedule is available after training and implementation is completed.
Benefits:
Benefits begins day 1 – HSA and very reasonable premiums
401k match (and 100% contribution/match vested immediately)
15 days PTO plus additional 10 sick days, floating and paid holidays
Company paid Life Insurance, Short-Term Disability, Voluntary Life Insurance and Spouse/Child Life Insurance available
Salary commensurate with experience
Relocation assistance available
Bonus and merit increase (5%)
Less than 5% travel
Responsibilities:
Function as the quality organization’s SME with regards to the configuration, implementation, analysis, and maintenance of the eQMS across several facilities
Work hand in hand with a global team as it relates to integration, with a focus on GMP documents, training within a regulated environment. The first 90 days will be juggling training and working through integrations.
Be responsible for coordinating and executing activities needed to maintain compliance with cGMP and/or ISO 13485 and the integrity of the Quality Management System
Develop and maintain eQMS installation and configuration management procedures.
Provide troubleshooting expertise to end users on an ad hoc basis, consulting with the software vendor(s) as needed. Work with the vendor to troubleshoot and resolve application issues
Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation (CSV) procedures
Develop or review protocol, plans, scripts, reports, SOPs etc. associated with the implementation and maintenance of computerized systems
Provide QA oversight during risk, Part 11 and Annex 11 and regulatory assessments
Review changes to validated state of system through the change control and participate in planning and implementing changes
Serve as the QA contributor on projects pertaining to the interpretation of FDA and regulatory requirements for computer system validation
Execute document and change control processes to ensure standardization, accuracy, and completeness of documents
Maintain copies of Quality documents in files and electronic databases
Participate in cross-functional teams comprised of laboratory, materials management, EH&S, and Quality personnel across multiple sites to improve the use of the LIMS system and to design and implement added-value applications within LIMS and other local or global lab informatics environments
Implement the LIMS workflows and reports to meet business needs.
Manage the administration and implementation of the LIMS and all QC instrument software following policies.
Administer accounts, roles, and system functions per global and local LIMS procedures.
Solve end-user LIMS template and end-user LIMS data entry issues.
Develop and execute validation scripts as needed for change control issues
Define project scope, goals and deliverables in collaboration with management and stakeholders.
Requirements:
LIMS experience (Labware preferred)
5-7 years’ experience in the pharmaceutical/biotechnology industries
Prior experience implementing or administering an eQMS software system
Working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory
Experience as a sole contributor and Internal customer facing experience
Bachelor’s in biology, chemistry, engineering, or IT or years of related pharmaceutical of biotech experience
Superior database maintenance/development experience.
Familiarity with lab equipment
Excellent documentation and computer skills.
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Planet Technology and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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