QA Specialist
Title : QA Specialist ( Level 1 )
Visa : USC, GC, GC-EAD , H4EAD, OPT -EAD ,
Location : Onsite in Philadelphia, PA ( Need Local)
Duration : 6 months with possible extensions
Interview : 2 Videos
Need LinkedIn with pic.
Job Description :
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
Consultant's day to day responsibilities :
Initiating investigations resulting from product deviations and non-conformance issues.
Assisting with the development of CAPA's
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 CoA's
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 Bachelor's 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 SOP's : paperless environment
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