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Quality Computer System Specialist

Job Description

 QUALITY COMPUTER SYSTEM SPECIALIST
COPPELL, TX
  
Project Description:
The Quality Computer System Specialist will be responsible for administrative duties for computerized systems as well as assuring the design, installation, implementation, and data integrity computer systems at the Client Supply Site meet all applicable industry standards and regulatory requirements. 
 
  • Perform administration function for computer systems within the QC laboratory and manufacturing systems. This includes laboratory instrumentation, GQLIMS, BMRAM and SAP as well as automated control systems. 
  • Review qualification and periodic review activities for computer / control systems including the following documents: URS, DQ, IQ, OQ, PQ, and Trace Matrix. 
  • Perform and/or support periodic review activities for QC computer systems including FT-IR, XRD, XRF, etc. Perform and/or support periodic review activities for manufacturing computer systems including such as BMRAM, Wonderware and SAP. 
  • Manage changes and updates to the QC computerized systems. 
  • Review the design and implementation of computer/control systems to assure that security and data integrity are maintained. 
  • Support IT infrastructure qualification activities. 
  • Analyze data and information to determine whether computer / control systems are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis. 
  • Prepare, document, and/or evaluate change controls for computer / control systems to ensure that they remain in qualified, validated state.
  • Identify and investigate unusual or unexpected events, data, or sources of variation during the implementation and validation; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions.
  • Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP.
  • Other responsibilities as assigned by department management. 
 
Required Skills:
  • Bachelor's degree in a science, technical, or engineering field.
  • At least two (2) years' experience in pharmaceutical or related industry with demonstrated knowledge of computer systems design, qualification, data integrity and validation.
  • Must have attention to detail. Work requires a high degree of accuracy in complex documentation.
  • Knowledge of computer system and control system design and validation concepts including GAMP.
  • Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation.
  • Awareness of qualification of control systems and computer system validation (CSV) preferred.
  • •Able to work cooperatively with other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations.
  • Must effectively evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products.
  • Excellent technical writing and verbal communication skills.
  • Requires the ability to apply scientific and analytical principles for solving problems and proper design of qualifications and validations.
  • Working knowledge of cGMP and other applicable guidelines and regulations.
 
This 12+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: michellea@alphaconsulting.com
 
ALPHA'S REQUIREMENT #19-01180
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

#ZR
 

Job Requirements

 

Job Snapshot

Location US-TX-Coppell
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type IT & Technical
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Company Overview

Alpha Consulting

Alpha Consulting Corporation is a privately owned staffing firm in East Brunswick, NJ. Alpha has staffed IT positions for major companies in the pharmaceutical industry since 1994. Alpha's experienced recruiters, account managers, and support staff have a combined 75+ years of placement experience and focus on finding a strong match between assignment and consultant. Alpha offers direct deposit, a comprehensive medical plan, and a 401K plan. We hope to help you find your next opportunity soon! Learn More

Contact Information

US-TX-Coppell
Michelle Ashen
Snapshot
Alpha Consulting
Company:
US-TX-Coppell
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
IT & Technical
Store Type:

Job Description

 QUALITY COMPUTER SYSTEM SPECIALIST
COPPELL, TX
  
Project Description:
The Quality Computer System Specialist will be responsible for administrative duties for computerized systems as well as assuring the design, installation, implementation, and data integrity computer systems at the Client Supply Site meet all applicable industry standards and regulatory requirements. 
 
  • Perform administration function for computer systems within the QC laboratory and manufacturing systems. This includes laboratory instrumentation, GQLIMS, BMRAM and SAP as well as automated control systems. 
  • Review qualification and periodic review activities for computer / control systems including the following documents: URS, DQ, IQ, OQ, PQ, and Trace Matrix. 
  • Perform and/or support periodic review activities for QC computer systems including FT-IR, XRD, XRF, etc. Perform and/or support periodic review activities for manufacturing computer systems including such as BMRAM, Wonderware and SAP. 
  • Manage changes and updates to the QC computerized systems. 
  • Review the design and implementation of computer/control systems to assure that security and data integrity are maintained. 
  • Support IT infrastructure qualification activities. 
  • Analyze data and information to determine whether computer / control systems are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis. 
  • Prepare, document, and/or evaluate change controls for computer / control systems to ensure that they remain in qualified, validated state.
  • Identify and investigate unusual or unexpected events, data, or sources of variation during the implementation and validation; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions.
  • Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP.
  • Other responsibilities as assigned by department management. 
 
Required Skills:
  • Bachelor's degree in a science, technical, or engineering field.
  • At least two (2) years' experience in pharmaceutical or related industry with demonstrated knowledge of computer systems design, qualification, data integrity and validation.
  • Must have attention to detail. Work requires a high degree of accuracy in complex documentation.
  • Knowledge of computer system and control system design and validation concepts including GAMP.
  • Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation.
  • Awareness of qualification of control systems and computer system validation (CSV) preferred.
  • •Able to work cooperatively with other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations.
  • Must effectively evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products.
  • Excellent technical writing and verbal communication skills.
  • Requires the ability to apply scientific and analytical principles for solving problems and proper design of qualifications and validations.
  • Working knowledge of cGMP and other applicable guidelines and regulations.
 
This 12+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: michellea@alphaconsulting.com
 
ALPHA'S REQUIREMENT #19-01180
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

#ZR
 

Job Requirements

 
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Quality Computer System Specialist Apply now