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Quality Control Testing Technician I
Ref No.: 17-02750
Location: Rocky Mount, North Carolina
Start Date / End Date: 10/02/2017 to 07/01/2018
The LIMS Labware Associate will be responsible for completing instrument template spreadsheets from information from site source documents to allow the building of instrument master data into a site LabWare LIMS system (gLIMS). Additionally, the associate will test builds as part of the change control process for LIMS master data including but not limited to products, specifications, and methods in LIMS.


POSITION RESPONSIBILITIES
1. Identify correct product testing types from product specifications.
2. Conduct validation testing and documentation using Application Lifecycle Management Quality Center.
3. Verify that master data is built per requirements.
4. Participate in the development and/or revision of site and/or Standard Operating Procedures (SOPs).
5. Work with the site Project Manager/LIMS Administrator to meet site implementation goals and requirements.

ORGANIZATIONAL RELATIONSHIPS

The LIMS Labware Associate will be a member of the gLIMS project team at Rocky Mount. The team is responsible for the implementation of the Environmental Monitoring module of LabWare LIMS. Team members serve as a representative of the Labs/Quality Operations for the Pharmaceutical Rocky Mount site. This role will report to the site cell lead for implementation of the Environmental Monitoring module.

EDUCATION AND EXPERIENCE
• Bachelor's degree in a scientific or related discipline with quality operations related laboratory experience, particularly in a biological lab or monitoring environment
• 1-3 years of experience in the Pharmaceutical industry or relevant business experience
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and site procedures
• Demonstrated attention to detail
• Good oral and written communication skills
• Must be able to work independently
• Aptitude for computer related work
• Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.)
• Demonstrated ability to work in a team environment and manage workload to meet deadlines
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability

TECHNICAL SKILLS REQUIREMENTS

• Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.)
• Experience with Lab Ware LIMS preferred
• Experience with Application Lifecycle Management Quality Center (ALM-QC) preferred

PHYSICAL POSITION REQUIREMENTS

• Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 pounds per activity 4 times per shift, work around moving equipment, work with biological materials.
• Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.