QA LABORATORY SYSTEMS SPECIALIST II-8804130429
Description
Neutrogena, a member of the Johnson & Johnson Family of Companies, is recruiting for a QA Laboratory System Specialist II, Located in Los Angeles, CA.
The QA Laboratory Systems Specialist II is accountable for support, maintenance, and management of all computer systems for the QA laboratories, including LIMS (Laboratory Information Management System), Empower, Vitek II. These applications include the chromatography system (Empower) and database reporting system. Also, this individual is accountable for coordination, development, and implementation of software systems development and validation testing relating to LIMS. Interacts with software vendors and QA/QC to ensure proper operation and installation of vendor software applications of the Los Angeles Information Systems Network. This role will assists all QA laboratory functional groups; i.e. Analytical Laboratory, Microbiology Laboratory, Stability group, or other groups as deemed appropriate. This individual will collaborate with the user administration and change management of the systems to ensure that a high level of compliance is maintained.
Under direction of the Laboratory Manager, this individual is responsible for developing, supporting and improving computerized system according to internal and external specifications. Provide technical support and serve as a guide to system users. Assure the compliance to all qualify control policies, procedures and systems to ensure the timely release of high quality product in support to the supply chain process. Comply with Neutrogena&'s policies, procedures, and quality standards, as well as safety and environmental regulations. Leading the site-level implementation of Lab Informatics applications and business processes.
Job responsibilities also include: managing the implementation and maintenance of LIMS Master Data. Ensuring the compliance management of LIMS Master Data following the applicable enterprise SOP&'s. Organizing site-level business input on system User Requirements and Functionality. Focus on developing and improving Lab Systems that support the achievement of laboratory goals. Develop software enhancements/upgrades to meet evolving user requirements. Troubleshot software problems using knowledge of system and through interaction with software vendor. Develop and execute validation/test protocols to test software modifications and write validation reports summarizing the execution of validation test protocols. Coordinate the implementation of changes to ensure that changes do not disrupt system operations including the completion of change control documentation to assure that changes are properly authorized. Administer security changes to the LIMS laboratory applications systems, including providing IDs for new users, changing security levels as authorized and inactivating users who no longer should access the LIMS application systems.
Assists in assuring that equipment is selected and used that is capable and qualified to perform its intended function and in assuring that new/modified laboratory software comply with corporate and local plan policies, procedures, and government regulations. Develop and administer test code and specification changes for local changes as needed. Provides training to laboratory associates. Stays abreast of regulatory compliance changes (e.g., electronic signature, etc). Coordinates all activities of lab system and equipment contractors. Provides technical expertise and serves as expert for system users in order to support the supply chain. Maintains related Working Instructions and SOP&'s up-to-date and monitors compliance. Manages system security: user ID assignment, regular password changes and log files monitoring. Manages system operations: Backup, shutdowns, system maintenance, etc. Provides user training and support. Recommends process enhancements. Administers system change control.
Performs data recovery. Performs periodic system reviews/re-qualifications (as needed). Perform special projects as directed by management. Represents LAP in regional laboratory system discussions. Management of site-level peripheral hardware (Label Printers, Barcode Scanners, and Instrument Interfacing Equipment). Primary contact for supply chain/quality unit regarding general usage/performance questions/reporting or issues related to GSS or SAP. Supports the implementation and execution of laboratory systems related quality improvement projects at Neutrogena. Investigate problems, identify causes and recommend preventative measures to supervision.
Utilize computer systems in support and troubleshooting. Under supervision carries out general instructions in accordance with standard practice. Requires some initiative and judgment. Actions checked periodically. Elevate and communicate significant issues to Management. Participate on Lab systems projects with peers. Complies with and enforce Neutrogena&'s policies, procedures, and quality standards as well as safety and environmental regulations. Other duties as assigned by management.
Qualifications
Minimum 3-5 years experience in an FDA regulated industry (Consumer Products or Pharmaceutical preferred. Broad-based experience or combination of experience, in application of LIMS systems in a comsumer products or pharmaceutical laboratory environment. Experience with Laboratory Information Systems and Chromatography systems. Knowledge of cGMPs, cGXPs, cGLPs and compliance. Broad technical knowledge of Computer System Validation (CSV) part 11 and regulations. Knowledge in computer system administration. Knowledge in analytical and instrumental chemistry. Good communications skills in both written, verbal, and oral. Technical writing skills are required. Knowledge in Laboratory Systems flows and efficiency. Ability to work in teamwork environment. Time management skills are required.
This position is located in Los Angeles, CA.
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J2W:LI
Primary Location:North America-United States-California-Los Angeles
Organization: Neutrogena Corporation (6107)
Job: Quality Assurance
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