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Quality Systems Administrator

Company: Pfizer
Location: Rocky Mount
Posted on: June 8, 2019

Job Description:

ROLE SUMMARYThe Quality Systems Administrator performs system analysis and identifies / implements mitigations as needed to assure that the data generation and documentation systems are maintained in a validated state with integral data generation for the Rocky Mount Laboratory computerized systems. These systems include, but are not limited to, Lab Information Management System (LIMS), NuGenesis, Empower and other lab applications utilized for instrument and data management to assure that data generated is integral and complete throughout the data retention lifecycle in conjunction with BTAMS. This position is also essential in performing assessments of electronic and manual data generation processes for other systems at the Rocky Mount site to assure that data integrity is maintained throughout the data retention lifecycle.This position performs setup / pre-launch assessments and implements post-launch enhancements to the laboratory systems that generate and maintain data in order to created / maintain data integrity. Responsibilities include assessing changes to user and testing specifications and regulatory requirements per 21 CFR Part 11, PIC/s Annex 11, GAMP5, and current regulatory Data integrity guidance documents, determining the impact of software updates and user requested changes with regard to product and process data quality, and implementing appropriate measures / controls within the laboratory systems to ensure compliance. The roles are also responsible for performing system administration, application support, software / hardware validation support, incident management, technical expertise, and production support to quality labs, lot release/supply chain, and manufacturing. Understanding of database structure and system security is necessary for this position.System support may include system configuration, designing and building application reports or reporting tools, maintaining or creating master data for new or existing products, software utilities, maintaining system documentation, and providing ad hoc support to other departments as needed. This position is expected to provide leadership to support system evolution and continuous improvement for all lab system and to support laboratory informatics and data integrity efforts applicable to data generated from these systems and processes.ROLE RESPONSIBILITIES

  • Provides technical support for laboratory quality system to the Quality Control laboratories, Biological Quality (BQ), Chemical Quality (CQ), and Supplier Quality (SQ);
  • Ensure that the systems comply with all applicable regulatory standards pertaining to Electronic Records / Electronic records and Data Integrity guidance documents.
  • Diagnostic support for application associated with laboratory data generation and management.
  • Management and timely resolution of technical incidents through the standard incident and problem management process; Responsible for elevation of incidents to 2nd tier support and summarization and reporting of incidents to system owners and effected users when required.
  • Ensure site on-time implementation of laboratory quality system through support of user requirements, functional design, and management of master data configuration, data migration, reporting design, system validation, SOP generation, development, and end-user training.
  • Provides a key role in system governance.Review and management of system change control processes, including establishing or revising user requirements, design requirements, functional specification, design specifications, or qualification protocols.
  • Define and manage process efficiency and continuous improvement projects for laboratory systems for timely updates / releases.
  • Technical writing for system validation protocols, standard operating procedures, and other technical documents in support of validation/operations.
  • Support business in data generation and evaluation processes including, but not limited to, creation, validation, and maintenance of reports, calculations, and queries within quality systems.
  • Support system periodic review, security review, and audit trail review activities.
  • Support audits and inspections to provide data and information on request, provide ad hoc support to other department to assure compliance with applicable regulatory requirements.BASIC QUALIFICATIONS
    • Bachelor's degree in life sciences, computer science, or engineering required. Master's degree preferred.
    • Minimum of 5 years working in a GMP-regulated environment required, pharmaceutical industry preferred.
    • 2 years related laboratory application management experience required: configuration, validation, implementation, and system administration.
    • 2 years of experience in a GMP environment with working knowledge of laboratory specification and test documentation in electronic systems required.
    • 2 to 4 years in computer system validation and analytical instrumentation testing required.
    • 3+ years experience in LIMS system management required.
    • 1+ years experience in chromatography system administration, such as Empower required.PREFERRED QUALIFICATIONS
      • Proficiency in LIMS instrument integration.
      • Experience in NuGenesis, Chromeleon, or WinKQCL.
      • A working knowledge of design of laboratory data recording.PHYSICAL/MENTAL REQUIREMENTS
        • Working knowledge or biology, chemistry, life sciences with strong skills in computer system management.
        • Knowledge of cGMPs and regulatory requirements around computer systems including 21 CFR Part 11, GAMP5, Data Integrity Guidance documents, and applicable ISO standards.
        • Strong analytical skills and balanced decision making; must have the ability to formulate appropriate system queries.
        • Possess good communication skills and attention to detail.
        • Knowledge of risk and impact assessment tools strongly desired.
        • Knowledge of root cause analysis tools and investigational skills preferred.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This role is 1st shift, Monday - Friday. May be required to work non-standard hours to support laboratory systems at the Rocky Mount site.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.Other Job Details:
          • Last Date to Apply for Job: 16 JUNE 2019
          • Eligible for Employee Referral BonusN (Other) (United States of America)Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Keywords: Pfizer, Rocky Mount , Quality Systems Administrator, Other , Rocky Mount, North Carolina

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