5031 Controller Medical Device jobs in Edison,NJ

A minimum of a Bachelor's degree or equivalent university degree is required
A minimum of two (2) years of relevant work experience.
Experience performing one or more of the following cellular and/or molecular-based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or potency assays.
Experience within the biopharmaceutical or pharmaceutical industry.
Experience with aseptic processing in biosafety cabinets and/or ISO 5 cleanroom environments.
Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory.
Knowledge of cGMP regulations and Good Documentation Practices (GDP).
Experience with Quality Control document reviews and regulatory inspection processes.
Proficiency in technical writing (e.g., test methods, SOPs, protocols, etc.).
Excellent written and verbal communication skills.
Requires the ability to meet physical demands, including lifting up to 20 lbs, and standing or sitting for extended periods in a laboratory setting; performing visual inspections of materials (e.g., color, appearance, particles); and documenting observations during laboratory testing.
Requires up to 5% domestic travel to other sites/locations.