QC Microbiology Specialist II at 9627 Corixa Corporation


Category
Quality Assurance/Safety
Company
9627 Corixa Corporation
Location
Hamilton Montana, OH
Posted
10/21/2018
This job is no longer available

QC Microbiology Specialist II 185354

Job Purpose

Perform routine QC testing to support the manufacture and release of products as well as non-routine testing.  Understand test equipment and scientific principles of methods within the scope of their responsibility.

Key Responsibilities

  • Perform testing following written methodologies and report results which are clear, defensible and right the first time.  Demonstrate understanding of the scientific principles and method validation for the assays which they perform.
  • Perform non-routine tests, studies or projects with minimal supervision
  • Review laboratory results and provide technical review of other documentation as assigned by supervisor.
  • Support the qualification, operation and scheduled maintenance of laboratory equipment, including automated and computerized systems and assure they remain in a functional, validated state.   Escalate issues associated with equipment and assays as required.
  • Support Change Control, LSOP authoring/revision and CAPA tasks with minimal supervision.  Support and/or lead  lab investigations (EHS, Unplanned Events, AR, OOS, etc.) as necessary
  • Understand and comply with current GMP regulations and quality systems.  Promotes a quality mindset in every action, every day by routinely communicating concerns, issues and best practices.
  • Accountable for supporting QC and site operations, communicating in a positive, professional manner, supporting operational excellence principles and supporting and implementing management decisions
  • Responsible for application of GSK safety and environmental guidelines and identification, escalation and prevention of safety issues.  Duties may include minimal handling of hazardous waste from laboratory activities to satellite storage areas. Annual training on area-specific hazardous waste handling is required. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site’s RCRA compliance program.
  • Assist in maintaining area of responsibility in a state of inspection readiness
  • Performs other departmental duties as assigned by management

Basic Qualifications

  • Bachelor of Science or Bachelor of Arts degree in a scientific discipline.    
  • 2 years Experience in a cGMP laboratory or related industry experience.

  • Good written and verbal communication skills.

  • Proficient in standard MS software including Word, Excel, PowerPoint. 

  • Demonstrated ability to work successfully both independently and in a team environment

  • Good time management skills

Company Details

At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

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