QC Computer Systems Specialist
About the Job
Responsible for maintaining all laboratory instruments’ software and hardware including laboratory computer systems in compliance with laboratory ERS regulations and the administration of Quality Control computer systems. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Administers the proper and in compliance use of Empower Chromatographic Acquisition system in the chemical laboratory and creates, validates and keeps update methods/custom field for Empower, Nu Genesis and Non Chrome systems. Administers the LIMS system for the laboratories and Product Release areas use including the creation and maintenance of Multi Level Product (MLP), material class and sampling plan setting, environmental monitoring and retain modules and applicable procedures. Administers the SAP Quality Module and Quality transactions activities such as\: Generates reprints of Sampling Drawing Instructions (SDI) as required. Provides quality information for new SAP codes for new materials or Drug Products as part of the Material Master Maintenance using the CMat system. Updates SAP inspection Plan. Releases Inspection Lots. Conducts training to users related to SAP Quality Module. Represents Laboratory SME in the design, development and execution of validation plans and protocols for the Quality Control Laboratory systems. Provides training for end-users on Empower and Non Chrome applications as NIR, UV, and FTIR and on procedures, applicable to computer systems. Creates validation and extended testing sample jobs in LIMS. Prepares, validates and maintains excel spreadsheets for calculations. Creates and modifies user’s accounts for Empower and Non Chrome systems. Revises Non chrome, Nu Genesis, Empower (VMP, URS, TM & IOQ) reports as system owner. Performs/reviews User Access Review for Non Chrome, Empower and LIMS systems. Generates and maintains related area Standard Operating Procedures. Provides back up of data for non-chromatography equipment, chromatography systems and Empower projects as required. Reviews laboratory computerized systems validation periodic review reports performed by IT group. Performs Empower SQT and buffering tests to the Empower LACE’s equipment. Responsible for troubleshooting at the site before escalating any issues to LIMS IT team. Ensures that there is full knowledge of existing and new LIMS functionality and will work with HQ LIMS and site Quality teams to implement that functionality for the benefit of the site. Work with site users to identify issues or possibilities for improvement addressing those issues through change control and performing site Users Acceptance Test to help implement the change. Accountable for representing the laboratory systems as the SME during audits as regulatory inspections. Supports all site initiatives and any other assignment based on business needs.Bachelor’s Degree in Science (Chemistry or Biology/Microbiology). Five (5) years of laboratory work experience required. Knowledge in computer necessary, Literacy in Windows such as X, NT, 98. Two years of experience in Chromatography Data Acquisition Systems such as Empower. Two years of experience in Laboratory Information Management System (LIMS) administration. Bilingual (Spanish/English). Effective oral and written communication skills. Ability to impact and influence people/areas with and outstanding company to deliver superior business results. Through knowledge/experience with laboratory instrumentation, analytical methods/techniques. Broad knowledge of cGMP and FDA regulation. Customer focus, sense of urgency, organized and oriented toward teamwork and decision making able to use machinery, equipment, tools and materials related to his/her work. Self-starter and organized. Ability to work under time pressure. Willing to travel when necessary. Availability to provide support during weekends and after working hours, holidays and irregular hours.