Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GDP) for commercial and clinical product in a timely matter. Ensure all documentation is legible, complete, and correct. 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. Perform in-process product inspection and testing for commercial and clinical product. What makes you successful: 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 past experience working with the following; Agile/PLM, Oracle and/or Camstar software programs. What you'll get: A front row seat to life changing CGM technology. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. Typically requires a minimum of 0-2 years of related experience and a High School diploma/certificate or equivalent. Must be able to communicate effectively in English. Examples of English language proficiency may include (but are not limited to): ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals; ability to write routine reports and correspondence; ability to verbally communicate with leadership, employees, and auditors; ability to comprehend spoken language. Physical Demands: Employees in this position may be required to perform the following physical activities: standing, walking, and sitting for extended periods of time; frequent use of the hands, fingers, wrist, and greater arm to handle small materials, tools, boxes, and trays; lifting and carrying objects up to 50Ibs; occasional overhead reaches and lifts; occasional lifts and reaches below the knee; occasional pushing and pulling of materials and objects with moderate forces; occasional crouching/kneeling, twisting, and squatting movements.
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