Summary:

Performs necessary duties to evaluate assemblies and finished products to ensure conformance to drawing requirements, specifications and approved procedures.  This position is responsible for ensuring that good manufacturing practices and good documentation practices are maintained in manufacturing, the coordination of the non-conforming materials process, and the review of electronic and paper Lot History Records.

 

Functional Description:

Performs inspections, checks testing and sampling procedures for product manufacturing processes. Carries out packaging line, manufacturing inspections and sampling and testing of incoming components and raw materials to ensure that company standards are met. Monitors critical equipment and instrumentation. May draft procedures and assist with validating or troubleshooting testing methods, including assays. May apply approval or rejection labels to bulk raw materials once analytical data is evaluated.

 

Essential Duties and Responsibilities:

Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial and clinical product in a timely matter. Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task. Ensure all documentation is legible, complete and correct per current Good Manufacturing Practices (GMP). Inspect labeling for the finished product. Understand and perform line clearance activities in manufacturing. Perform in-process quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices. Assist with the NCMR process during manufacturing of commercial and clinical product. Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel. Perform in-process product inspection and testing for commercial and clinical product. Must be able to distinguish between certain colors and pass an annual color vision test Familiarize yourself with the manufacturing processes. Review shipping documentation to assure accurate order shipment. Works closely with Research & Development, Regulatory Affairs, Clinical, and Manufacturing groups. Provide training for new employees. Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department. Must have strong organization skills and attention to detail. Assumes and performs other duties as assigned.

 

Required Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ideally has experience working with the following; Agile, Oracle and/or Camstar software programs.

 

Experience and Education Requirements:

Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent.