QA Specialist

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