Quality Control Expert

Company: Prokatchers LLC
Location: Rocklin
Posted on: June 24, 2022

Job Description:

Position: Quality Control Expert 1/ Stability Analyst Duration: 12+ months Contract (Temp to Perm) Location: 6600 Sierra College Blvd, Rocklin, CA 95677 Shift Timings: 8:00am - 5:00pm, M-F Job Description: Under moderate supervision, the Stability Analyst will be part of the Quality team and responsible for performing stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements. Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS. 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 Job Requirements: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 - 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 They will be looking at results and confirming accuracy Testing on instrumentation Working in a lab Performing Assays Recent Grads - willing to train

Keywords: Prokatchers LLC, Rocklin , Quality Control Expert, Other , Rocklin, California