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Sr. Subcontract Administrator (INF)

LanceSoft Inc

Atlanta, GA

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JOB DETAILS
SALARY
$42–$50 Per Hour
JOB TYPE
Contractor
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Certified Quality Engineer (CQE), Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Contract Management, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Insurance Certifications, Manufacturing Engineering, Marketing, Medical Equipment, Organizational Skills, Process Improvement, Product Support, Project Development, Purchasing/Procurement, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Regulations, Regulatory Compliance, Research & Development (R&D), Root Cause Analysis, Scientific Method, Six Sigma, Team Player, Work From Home
LOCATION
Atlanta, GA
POSTED
30+ days ago
Title : Sr. Subcontract Administrator Duration: 06 Months Pay Range: $42.00 – $50.00/hr. On W2 Work type : Remote Job Description: Quality Engineers lead and drive process and product improvements and provide specialized quality-related services to R&D, Quality Assurance, Manufacturing Engineering, Production, Procurement, and Marketing. They develop, implement, and evaluate tools and equipment for quality assurance and product/process improvement. Additional responsibilities will include: Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms. Support 3rd party audit of site through audit prep and participating in the front/back room. Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities. Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback. Act as an SME in quality assurance and scientific matters as applicable. Develop and drive key strategic quality assurance initiatives throughout the organization. Contributes to the development of new projects/programs/processes. Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc. Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise, and promoting solutions. Job Requirements Bachelor’s or Master’s Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience. Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred. 4+ years of experience in a similar position within the Life science industry. Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required. Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations. An effective communicator at all levels, both internally and externally. Team player with the ability to make independent decisions within the framework and guidelines of the organization.

About the Company

L

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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