Senior Associate QA (JP4533)

Location: West Greenwich, RI
Date Posted: 07-26-2018
Job Title: Senior Associate QA (JP4533)
Location: West Greenwich, RI.
Employment Type:  Contract
Business Unit:  Stability Program Management
Duration:  3 years
 
3Key Consulting Inc. is looking for a Senior Associate QA with 3+ years’ experience in GMP systems including EDM Quality and LIMS for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Candidate will support data verification of product quality documents used in regulatory filings and routine stability support as required. Also, will generate chromatographic overlays in support of regulatory filings as needed.
 
Top Must-Have Skills:
  • Previous experience in GMP systems Ex. EDM quality and LIMS.
  • Minimum 3 years’ experience required.
  • Strong Microsoft/adobe skills - Data review and transcription of data.
  • Strong documentation skills - tracking and follow-up of issues.
  • Attention to detail, ability to work independently and Excellent communication skills
 
Day to Day Responsibilities:
Candidate will support data verification tasks on Product Quality technical documents. Data verification supports the review and verification of transcribed data into Product Quality technical documents which are used for Regulatory submissions, stability study documents and other technical reports as required. The ideal candidate will be able to navigate LIMS (data systems), various document management tools, and manage day-to-day tasks with minimal supervision.
 
The candidate will be working directly with authors to ensure data transcribed into technical documents is accurate and ensure the appropriate source documents are provided to execute data verification as required.
 
Why This Position Is Open:
Backfill.
 
Employee Value Proposition:
We are a high performing team that interacts across all Amgen sites supporting product quality documents used to support stability studies, marketing applications, INDs and BLAs. The team is given the freedom to perform independent with possible option for work flex depending on performance.
 
Red Flags:
  • No GMP experience.
  • Less than 3 years’ experience in a GMP environment and pharmaceutical experience.
 
Interview process:
Phone interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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