Quality Control Testing Technician I

Location: Rocky Mount, North Carolina
Posted On: 9/8/2017
Job Code: 8588-1
Job Description
Job Description: POSITION SUMMARY Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document. 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 In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required. Below is a representation of the kind of responsibilities expected. Other duties not included below are typically required for the job. 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 Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate. 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 Rocky Mount site. This role will report to the site cell lead for implementation of the Environmental Monitoring module. EDUCATION AND EXPERIENCE Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible). • 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 Indicate the technical skills required and/or preferred, as applicable. • 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 Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc. Please include any hazardous materials or non-standard working environment the contractor will have exposure to which may require additional medical testing and/or apparatus fitting for OSHA compliance. • 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. Position Comments visible to MSP and Supplier: Please note actual job title is as follows: LIMS Labware Associate
Category:Non-IT  code:new
Job Requirements
Quality Center, MS Excel, Compliance, Management, MS Word

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Ajaykrishnan Ks