QC Validation Specialist

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

• Kardex Remstar Verticle Carousel Storage Units
• Walk-in Refrigerators
• Reach-In Refrigerators/Freezers
• EyeC Proofiler Systems
• Dose Accuracy Instrumentation
• Zwick AutoTesters and Pentesters
• FT-IR/NIR
• Raman Spectrophotomers
• Waters HPLC/UPLC
• Atomic Absorption Spectrophotometers
• Malvern Particle Size Analyzers
• Total Organic Carbon Analyzers
• HIAC Particle Size Analyzers
• Downflow Booths/Fume Hoods
• Ovens/Muffle Furnaces
• Thermometers
• Light Meters
• Balances
• Pipettes
• Milli-Q Water Systems
• pH/Conductivity Meters
• Glasswashers
• Other Benchtop Equipment as defined by the project