Computer System Validation Specialist. Job at Quality Chemical Laboratories, Wilmington, NC

QllnR0dkejhJTTlLVE44YWtidkJQTHMweXc9PQ==
  • Quality Chemical Laboratories
  • Wilmington, NC

Job Description

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Computer System Validation Specialist.

Responsibilities:


  • Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.

  • Track and resolve deviations/exceptions during qualification activities.

  • Work with company management to implement changes and upgrades to computer systems

  • Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications

  • Communicate Computer System Validation approaches and requirements during audits.

  • Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes

Qualifications:


  • Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).

  • Experience in writing computer system test scripts, validation protocols and summary reports
    Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks

  • Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution

  • Capable of managing multiple sub-projects, duties and tasks

  • Effective at communicating clearly and concisely, both orally and in writing

  • Able to work both independently and as a member of a cross-functional project team

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control ,  Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.  

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company.   We now also offer subsidized childcare at our newly acquired childcare facility.  

QCL is an equal opportunity employer.

recblid 81tfknj53p1rpengnmtuqtpng52iuj
Quality Chemical Laboratories

Job Tags

Similar Jobs

Papa John's Pizza

Delivery Driver Menomonee Falls, WI Job at Papa John's Pizza

 ...Job Description Job Description Now hiring Delivery Drivers for our Menomonee Falls, WI Papa Johns location! Full and part time available for night shifts, some weekend availability will be required. Earn up to $16 to $20 an hour. Drivers earn up to $13/hour... 

Jobot

Environmental Compliance Consultant (Apply in minutes) Job at Jobot

 ...NSPS, and oil and gas compliance * Prepare and submit permit applications and air quality permits * Develop and maintain environmental compliance plans and procedures * Conduct environmental assessments and audits * Provide technical support to operations and maintenance... 

ADI Management

AT&T Account Assistant - Entry Level Job at ADI Management

 ...We are looking for our next Entry Level AT&T Account Assistant to join our rapidly expanding Account Representative Team in the Louisville area! We are seeking a goal-oriented, determined, and self-starting individual who can add to our team and the overall growth of... 

48forty

Saw Shop Operator Job at 48forty

 ...setting up and operating power saws to slot, cut, and trim wooden pallets. Candidates with previous warehouse, lumber, carpentry, roofing, landscaping, logistics, and construction experience are encouraged to apply! All employment is contingent on completing a drug test... 

Option One Transportation LLC

Freight Agent Job at Option One Transportation LLC

OPTION #1 FREIGHT BROKER WORK FORM HOME OR YOUR OWN OFFICE AS A FREIGHT BROKER. YOUR...  ...&&&&&&&&&&&&&&&&&&& OPTION #2 FREIGHT AGENT WE ARE CURRENTLY LOOKING FOR...  ...DEVELOPER! YOU MUST HAVE SOLID AUTO TRANSPORT EXPERIENCE TO QUALIFY. YOU NEED TO HAVE KNOWLEDGE IN...