Stellar Consulting Solutions is a boutique business & technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects of any scale. We help forward thinking clients to solve specific problems by understanding their needs and align talent that can move fluidly to match skill supply and demand on a real-time basis.
Stellar Consulting has a unique combination of technical and digital skills to recruit, engage, and retain qualified talent. We have a stellar reputation for striving to achieve high ethical standards. Our use of Innovative techniques and industry best practices has made us one of the fastest growing boutique firms delivering to enterprise business.
Job Responsibilities:
(Primary Duties, Roles, and/or Authorities) 1. Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities. 2. Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners. 3. Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment. 4. Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility. 5. Review and update FMEA or Risk documents as needed for validation activity for the site 6. Perform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area. Duties include but not limited to execution of QA inspection to support dual operations, review and approval of documents such as batch records to support finished product release. Education and Experience: BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry. Knowledge and Skills: 1. Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies 2. Statistical Analysis basic knowledge e.g Minitab or Excel 3. Strong knowledge of Process Validation and equipment validation 4. Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management) 5. Hands on experience using Six Sigma methodology 6. SAP knowledge 7. Equipment management system such as BMRAM knowledge preferred 8. The ability to work in teams and independently with minimal supervision to obtain results as required. 9. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Physical Demands: (if applicable) 1. General physical requirements: ability to work in controlled environmental 2. Ability to work with laboratory grade equipment such as refrigerators, freezers, centrifuges, etc during validation work. Work Environment: (if applicable) 1. Onsite model 2. Ability to be present in manufacturing area as needed
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