Performs inspections, checks testing and sampling procedures for product manufacturing processes. 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 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. Initiate and 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 Familiarize yourself with the manufacturing processes. Review shipping documentation to assure accurate order shipment. 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. Typically requires a high school certificate (SPM) or Diploma in any field or equivalent with minimum 2 years of relevant industry experience and/or training. 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. Experience using computer Ability to understand and perform job per documents instructions in English Good interpersonal and teamwork skills. Must be able to flex schedule to work in different shifts to meet demand. Quality Assurance and/or QA/QC experience. Min 2 years in the medical device industry or manufacturing industry previous experience. Ideally has experience working with the following: Agile, Oracle and/or Camstar software programs.
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