Quality Computer Systems Specialist

Job Location(s) US-TN-Bristol
Posted Date 8 months ago(10/18/2021 4:43 PM)
Job ID
2021-5041
Company
USAntibiotics
Category
Manufacturing

Overview

QA Administrative functional role for ensuring that all QC computerized systems and interfaces are functional, validated, and in compliance with cGMPs, and all other regulatory expectations for data integrity.  Must administer the QC LIMS (Laboratory Information Management System) and ensure that hardware/software are validated and functional to support Bristol QC Laboratory operations, and assist with other computerized instrumentation and software, including the current chromatography data system.  Must ensure all computers and computerized systems are maintained and appropriately validated for the intended use, including the use of any electronic signatures and retention of electronic records.  All data must be appropriately archived and backed up/retained for the subject retention period, and all documentation is comprehensive and accurate per cGMP requirements.  All Quality unit software/hardware and equipment are managed in a manner consistent with regulatory and company standards.  Serves to support LIMS updates or changes (and interfaced systems and lab equipment or other computerized systems/laboratory instruments via change control process.   Assist with writing procedures.  Assist with equipment qualification, calibration checks, and validation as trained and assigned.  Maintain coding standards, administer training, perform problem reporting and resolution, conduct data archival and backup, system security, data integrity, etc.).   Monitor system hardware and make minor software and configuration changes and perform and document system checks (i.e., general software administrative duties and other technical QC support as assigned). Assist with execution and reporting of any instrument qualifications or routine calibration checks as trained and assigned. Assist with continuous improvements and Corrective and Preventive actions and internal audits and laboratory investigations, and IT/QC related inspection readiness in general.  Serve as principal QA technical support working with instrument technical representatives and QC Section Lab managers and Chemists to ensure data integrity and functional, compliant systems are available for business needs.

Description

  • Support objectives of Site and Quality unit and work in safe manner at all times.
  • Serve as System Administrator for the software and hardware components of the LIMS, i.e., LIMS (Laboratory Information Management System) and CDS (chromatography data system), and for any other computer systems, as assigned.  Maintain system interfaces.  Ensure data integrity.
  • Implement data changes via LIMS change control system to support changes to procedures which contain test data managed in LIMS. Assure adequate/compliant documentation for LIMS and other systems per regulatory guidance and cGMPs.
  • Perform system and security checks for the LIMS/CDS and maintain validated status of computer systems.  Perform other ancillary data management tasks as needed (e.g., assist with data mining for Annual Product Reviews as assigned, database archives and backups, and system report functionality).
  • Perform calibration checks and preventative maintenance on QC lab systems / instruments as trained / qualified / assigned.
  • Manage user accounts for LIMS or CDS or other systems to assure system security and appropriate level of access for associates’ roles.  Ensure all systems comply with the rules for Privileged Access, and Electronic Records and Signatures (as applicable).  Provide users with LIMS/CDS training on system operations/functionality per appropriate security level.
  • Maintain effective and productive relationships with internal personnel and external technical support groups and system/software suppliers (IT, technical representatives of subject external firms, and/or consultants). 
  • Maintain all validation records for the LIMS system, and other systems as assigned. 

 

Requirements

  • Minimum of 10 years of experience with LIMS systems, SAP, other related software systems.
  • Computer science or laboratory science degree or relevant laboratory/computer science/data management experience.
  • Knowledge of data base management and open VMS.
  • Extensive experience with LIMS, Waters’ Empower, SAP, Excel, Office, etc.
  • Validation experience.

 

PREFERRED QUALIFICATIONS

  • 10 or more years Pharmaceutical (cGMP) experience.
  • Laboratory experience or ancillary IT support experience.
  • Extensive experience with SAP, LIMS, and other common pharma related computerized systems.

 

Required Knowledge:

  • Knowledgeable of computerized systems (configuration, operation, and validation) in order to assure identification of system compliance issues and adequate decision making.
  • Knowledge of theory and operation of analytical laboratory instrumentation and any related interfaces and any databases in order to assure understanding for proper data integrity, data treatments/calculations, specification and acceptance criteria set up, etc., in LIMS and any other systems

 

EEO Statement

Jackson Healthcare and its family of companies are an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race,color,religion,sexual orientation,gender,gender identity and expression,national origin,age,disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.

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