Job Description

Overview

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.

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.

Qualifications

Qualifications

Competencies:

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

Judgment / Decision Making: Duties performed under general directions within a framework of established and routine guidelines; some modification and interpretation required.

Work Environment: Warehouse and air-conditioned office environment.

Physical Demands: Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer.