QC Validation Specialist

Insight Global

Clayton, NC

Skills Required:

Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
Experience in writing & executing validation protocols
Experience in managing projects preferred
Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
Working knowledge of GMPs required
Ability to act as project manager driving & implementing equipment projects required
Demonstrated ability to write & present technical/scientific documents & reports preferred
Understanding of QC equipment/systems, end user functionality & life-cycle management a plus

Job Description:

Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables. The purpose of this role is to provide QC Equipment validation services to support the release of QC equipment for the QC Expansion project. This includes work in the QC spaces in Finished Production (FP) and Warehouse/Interlogistics (WH/IL) spaces at the expansion facility as well as QC equipment qualification.

QC Equipment in Scope