Label Editor III

Title : Label Editor III Location : Columbus, OH Duration : 12 Month Assignment 100% Onsite Major Responsibilities Responsible for implementing and maintaining the effectiveness of the Quality System. Edits, reviews, proofreads, and approves labeling Change Control documentation and associated specifications such as PCCA, OP, MS, PBOM, PMS, etc. Reviews labeling for consistency with similar or related product specifications. Communicates and coordinates labeling and documentation approvals with other sites. Must be able to rearrange priorities on short notice to react to customer needs. Responsibilities include implementing and maintaining the effectiveness of the Quality System. Education Minimum education and why it is required. BA/BS degree in Science, English, Business, or a related field to ensure accuracy of highly technical information used by manufacturing operations and regulated by the FDA. Knowledge of regulations and standards affecting IVDs and Biologics. Requires a minimum of one to two years of experience in a technical, quality, or operational area. Must have the ability to problem solve, manage projects, influence internal and external groups, and provide leadership. The incumbent should have strong organizational and human relations skills to deal with various levels of individuals and functional areas within the division. Previous experience working within a Change Control system is helpful. Knowledge of regulations and standards affecting IVDs and Biologics. Accountability / Scope Labeling and documentation for new products or revisions must be completed accurately and on time. Quality of the product is directly linked to the accuracy of the associated documentation. Not meeting the scheduling requirements will result in a delay in new product introduction, which can have a far-reaching effect on product sales and can further result in a delay in implementing design improvement, which in turn can affect labor cost and product marketability. Failure to produce accurate copy can result in loss of printed supplies and potential product recall or field action. Documentation associated with the labeling Change Control process must meet Quality, Regulatory, and GMP requirements, as they are official records for audits and legal actions. Experience Required 7–10 years of experience needed. Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) #J-18808-Ljbffr Socket.dev