Senior Quality Control Engineer
Katalyst Healthcares & Life SciencesFrankford, DE
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Overview
Remote
On-site
Job Description
Roles & Responsibilities:
- Lead implementation and integration activities for GMP QC systems.
- Coordinate system configuration, data migration, deployment, and stakeholder engagement.
- Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
- Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
- Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.
- 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
- Experience managing system integrations, data migration, and cross-functional project delivery.
- Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities
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FAQs About Senior Quality Control Engineer Jobs at Katalyst Healthcares & Life Sciences
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This job at Katalyst Healthcares & Life Sciences is located in Frankford, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
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