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Senior Quality Control Engineer

Katalyst Healthcares & Life Sciences · Frankford, DE · GMP quality-control systems

Employment type

Full-time

Work setting

On-site

Location

Frankford, DE

Schedule

Day shift

Posted

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Job overview

The Senior Quality Control Engineer role is onsite in Frankford, DE. Compensation is not specified. The role supports implementation and integration of GMP quality-control systems. The position coordinates system delivery and validation so laboratory systems meet regulatory, data-integrity, and quality requirements. It works across QA, IT, business stakeholders, and vendors to support system acceptance and readiness for release and go-live.

What you'll do

  • Lead implementation and integration activities for GMP QC systems
  • coordinate configuration, data migration, deployment, and stakeholder engagement
  • monitor project progress, risks, timelines, quality, and budget
  • prepare status reports
  • support CSV/CSA and IQ/OQ/PQ validation activities and documentation
  • collaborate with QA, IT, business stakeholders, and vendors
  • support system acceptance, release readiness, and go-live.

What we're looking for

Skills & competencies
senior quality control engineer
frankford de
katalyst healthcares & life sciences
gmp
quality control systems
system implementation
csv
csa
iq/oq/pq
data integrity
lims
validation
Work arrangement
  • Weekend coverage required

Why this role

The posting specifies experience in pharmaceutical, biotech, or regulated GMP environments and familiarity with LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, or LabX.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.

Additional details

Industry sector
54
Industry
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Occupation code
17-2112.00
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