US - Quality Control Expert 1
ManpowerGroup
**Quality Control Expert / MEWPJP00028083**
**Location : 6600 Sierra College Boulevard Rocklin CA 95677 United States**
**Essential Duties and Responsibilities:**
+ Perform stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.
+ Record and document testing results accurately and per applicable regulatory and SOP requirements.
+ Data analysis using Microsoft Excel.
+ Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
+ Troubleshoot equipment problems.
+ Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
+ Maintain cGMP compliance in the laboratory.
+ Other duties as assigned or required
**Additional Responsibilities:**
Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management
Must be willing and able to work on weekends or extended hours as needed
**EDUCATION & EXPERIENCE:**
B.S. degree in a biological science or equivalent life sciences degree preferred, or equivalent combination of education and experience
Experience in medical device, drug, and/or biologics
General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards
**KNOWLEDGE, SKILLS & ABILITIES:**
+ Knowledge & experience in ELISA, bioburden and IHC testing
+ Ability to work independently and manage multiple analyses
+ Knowledge of cGMPs related to QC operations
+ Experience working in ISO 13485 and/or FDA regulated laboratory
+ Experience in SAP and/or SAP NEXT
+ Good computer skills, PC including MS Excel
+ Excellent written and verbal skills.
Thanks & Regards
Preeti Pandey
Sr. Technical Recruiter
Preeti.pandey@experis.com
**100 Manpower Place - Milwaukee, WI 53212**
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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