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rimary Function / Primary Goals / Objectives: This position is responsible for overseeing and managing the change Control packages for product labeling and for ensuring that documentation is appropriate, justified and approved by responsible functional areas according to established procedures. Also responsible for proofreading resulting labeling copy at various stages and for the development and maintenance of labeling related specifications and documentation associated with these specifications. Additional responsibilities may include participation with new product teams plus successful completion of assigned projects. 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 products 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: Indicate the minimum education and why it is required. BA/BS degree Science, English, Business or related field to ensure accuracy of highly technical information used by manufacturing operations and regulated by the FDA. Background: Knowledge of regulations and standards affecting IVDs and Biologics. Requires a minimum of one to two years 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: Describe the primary accountabilities of the position and the impact of actions. 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 affect 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.
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