| QA Speaclist at Remote, Remote, USA |
| Email: [email protected] |
| From: Vishal kashyap, sourceinfotechs [email protected] Reply to: [email protected] QA Specialist Level 1 $40 c2c is Max rate Onsite in Philadelphia, PA Length of contract assignment: 6 months with possible extensions Work schedule/typical work week/daily start and end time: Expected hours, can you work off site/remote Is there flexibility 2nd Shift Sun Wed, 12pm 10pm Some flexibility with the start time if we had a candidate who wanted to start at 1pm or 2pm. Cannot start before noon and need to finish up by midnight. 100% onsite The training period will be 6-8 weeks and will be Monday through Friday on 1st shift. Client description: Premier CDMO partner for large Pharmaceutical companies focused on Gene Therapies Project description: Describe the project and why the client is doing it Our client is expanding 2nd shift production due to an increase in customer demand. Recently the organization came out of a hiring slow down. As a result of the increase in production staff and activity on the second shift, QA needs to have additional resources in the manufacturing suites. These resources will be handling QA operations and provide support to the manufacturing team. Technology environment the consultant will be working in: SAP, eLIMS, Novatek, Master Control Consultants day to day responsibilities: Initiating investigations resulting from product deviations and non-conformance issues. Assisting with the development of CAPAs Visual inspection and observation of production process and staff in the GMP manufacturing suites. Participation in walk throughs. Review and approve deviations. Compile and review raw data and sample test results, including Final Reports and CoAs Review and approve executed batch records. Reviewing environmental monitoring trend reports and generating environmental summaries Required skills: 2+ years-experience in a QA, QC or Manufacturing role Associate or Bachelors degree Previous experience working in a life science, pharmaceutical or medical products GMP environment. Prior experience with batch record review. Previous experience reviewing and approving deviations or investigations. Previous experience with LIMS, QMS or other database for documentation and review of SOPs: paperless environment Thanks & Regards, Vishal Kashyap Technical Recruiter Email- [email protected] | Ph- (302)-204-7465 806, New Castle , Wilmington, DE, US, 19801 Keywords: quality analyst information technology Delaware Pennsylvania |
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| Thu Feb 01 23:58:00 UTC 2024 |