Title: Microbiology Lab Associate Location: Morrisville, NC Schedule: M-Fri 2 PM- 10:30 PM Type: Contract Responsibilities:
Fulfills microbial testing of finished goods, bulk, and raw materials for compliance to USP <61> microbial enumeration and USP <62> specified microorganisms following rapid microbial testing methods.
Accurately documents testing information and results in real time
Supports bulk and raw material sampling, testing, and release as needed. Additional testing includes: sensory, pH, viscosity, penetration
Reviews test data and performs release transaction in SAP
Demonstrates ability to support production lines by answering quality related questions and ensuring that the department is meeting the required quality standards.
Document and provide support for investigations pertaining to quality issues requiring resolution. Documentation includes: OOS, NCR, and Deviations.
Prepare and sterility test media for raw material testing use
Review COC (Chain of Custody) and Line Clearance forms prior to distributing the finished goods samples for testing
Assist in all laboratory cleaning processes and communicates testing supplies inventory needs
Create, revise and/or review procedures (SOPs, Job Aids and One Point Lessons) as needed.
Special quality projects as assigned
Requirements:
AA / AS Degree in a related field OR two (2) years of progressively responsible, related work experience in the manufacturing of industry (Pharmaceutical, Food or Cosmetics preferable)
Ability to operate micro lab equipment: Neogen Soleris, Autoclave
Ability to operate pH meter, viscometer, penetrometer, TOC analyzer
Ability to calibrate pH meter and scales
Provide support to the Microbiology Technician and backup to the quality laboratory
Prioritizes testing to support business needs
RFI, SWARM, FI, Quarterly Improvement Participant
Complete annual cGMP, Safety, and Sustainable Training. Complete both General and Safety Improvements quarterly
Follow all Safety, GLP, GDP, and GMP regulations and procedures
Perform all training related to safety, GMP, sustainability, and environmental
Understands and utilizes continuous improvement tools
Provide backup to Quality lab
Ensure all expired material is labeled appropriately
Provide backup to raw material sampler
Other Scope Factors: contributes to quality projects as assigned
Proficient computer skills in Work and Excel are mandatory, and the demonstrated ability to understand and learn additional programs is essential and required
Demonstrated ability in analytical reasoning is required.
Demonstrated ability in operating and troubleshooting testing equipment
Understanding of microbiology process, plating, methods, etc.
Exceptional attention to detail and organizational skills are required.
Experience in using SAP and Outlook preferred. Must demonstrate aptitude in using Warehouse Management System – SAP
Able to lift up to 40 pounds
BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.