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Ferno Document Control Specialist in Wilmington, Ohio

FernoThis position is responsible for the maintenance and control of all Ferno documentation as required for compliance to cGMP, FDA and ISO 13485 and 9001. The Document Control Specialist is also responsible for creating a self-managed workflow to keep all QMS records, policies, procedures, forms, and work instructions to the latest revisions and manage their release to their intended users. This is a hands on position that focuses on daily operations, there will be much interaction with multiple departments and a hands on approach to timely and effective responses will be required.Essential Duties and Responsibilities include the following.Ensure compliance to all regulatory requirements for creation, revision, processing, filing, on-site and off-site storage, retrieval, and disposition of controlled documents at the facility.Support the review, routing, distribution, and archival of GMP documentation.Assist with process requests for document changes; may coordinate SOP review meetings and periodic review of documents.Update and maintain document tracking databases and archival systems.Participate in writing and review Document Control associated SOPs proactively, working with others to build consensus and solve problems; assist authors with creation and revision of SOPs.Maintain SOPs, Batch Records and other documentation related to QA.Manage the control of other documentation and records.Support the Lot Release QA function with preparing Lot Release documentation and trending of lot specific quality data.Implement appropriate corrective actions to reduce delays in the product release process and ensure customer satisfaction.Provide support to the functional groups within the company on good documentation practices, document control requirements and documentation processing.Assist with supporting audit and regulatory inspection activities.Identify and implement improvements when gaps are identified through audits and departmental reviews.Lead and participate in efforts to implement Electronic Documentation Management System.Control the retrieval of documents.Receive and process requests for information from employees.Maintain requests for information in tracking logs.Other duties may be assigned.Education and/or ExperienceOne year certificate from college or technical school; or three to six months related experience and/or training; or equivalent combination of education and experience.And/or training; or equivalent combination of education and experience.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.Knowledge of quality policies, FDA Regulations and ISO Standards for medical device operations.Strong understanding of Document Control systems and Product Release processing.Strict attention to detail required. Problem detection ability a must.Ability to act effectively as a team member to resolve problems.Ability to effectively work with all functional groups.Excellent written and verbal communication and interpersonal skills.Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages.Strong knowledge of computer file management, Microsoft Office (Word and Excel)Ability to add, subtract, multiply, and divide in all units of measure, using whole number, com

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