Sampling Inspector II

Noven Pharmaceuticals•Miami, FL

5d•Hybrid

About The Position

Performs Quality tasks such as sampling and inspections designed to ensure incoming materials/components are dispositional in a timely manner and are in compliance with internal SOPs, safety initiatives, company policies, FDA and DEA regulations. Documents all work performed, ensuring accuracy and thoroughness. Informs Management of any quality issues, failures or deviations from established standards/procedures.

Requirements

High school diploma or equivalent.
Basic computer skills required.
Basic math skills required (i.e., calculating percent, square root, addition, subtraction, division, be literate in fraction and decimal).
Ability to read, write, communicate and follow instructions (verbal and written) in English is required.

Nice To Haves

Previous pharmaceutical/device industry experience as a Sampler or as a QA Inspector is desirable.

Responsibilities

Samples all incoming materials such as inactive and active raw materials, packaging components and labels.
Performs incoming quality tests on packaging materials and labeling as per specifications, SOPs and FDA requirements.
Performs printed text and artwork verification using the proof read system.
Documents all work activity on appropriate records, forms, and logs to ensure accuracy and compliance.
Delivers samples to the appropriate laboratories and retention areas.
Reviews records for cGMP compliance for accuracy and thoroughness.
Directs retention of materials, data, and preparation of documents for use by self or other company personnel
Informs Management of incoming quality problems, failures and deviations from established internal and regulatory standards.
Maintains sampling rooms in compliance with Noven, FDA, DEA and OSHA regulations.
Performs transactions in JD Edwards software when required.
Keeps accurate inventory and transaction records in compliance with Noven, FDA and DEA requirements.
Performs any other duties, as assigned.