Document Control Specialist

Bell International Laboratories is a complete solution and innovator, as experts in formulating and manufacturing high-quality products, including sun care, skin care, and consumer health products. Located in the Minneapolis/St. Paul metropolitan area, Bell International Laboratories is home to state-of-the-art manufacturing, warehousing, and laboratory facilities. More than 300 employees work in the facility, all dedicated to producing the highest quality products available.Position Summary:The Quality Assurance Document Control Specialist is a quality focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements as well as Bell International Laboratories approved procedures and output documents are accurate. The individual will assist in the day to day record management activities within Bell Labs complying with company and regulatory requirements.ResponsibilitiesPerform QA document control functions, including document login, tracking, processing, review, distribution, release and archiving of documents.Coordinate the revision, review, and approval and obsoleting of SOPs and other GMP documents. Responsible for ensuring area managers perform annual review of all cGMP documents and SOPs.Confer with document originators to resolve discrepancies and compiles required changes to documentsOrganize and ensure accurate and reliable filing systems for GMP documents.Create and maintain Certificates of Analysis' for customersMaintain in house training programs including training matrix, training files and annual audit of training files.Maintain key aspects of the quality system such as: IQOQ, document control, CAPA, Change Control, Deviations, OOS's, Annual Product Review, and othersActively participate in internal audits, customer audits and other activities as assigned by manager.Create Annual Product Reviews for all OTC products.Required Skills/AbilitiesKnowledge of laboratory equipment set-up and operation, common laboratory techniques and safe chemical handlingProficient at reviewing and editing documentationFamiliar with cGMP's and the ability to follow standard operation proceduresExcellent written, verbal and interpersonal communication skillsStrong critical thinking and problem-solving skillsAbility to prioritize multiple responsibilities and manage deadlines accordingly.Communicate effectively with all members of organization and all levels of managementExceptional attention to detail and high level of accuracy & organizationAbility to work independently with minimal supervision in a fast-paced environmentAbility to adapt quickly to changing policies and proceduresExhibit a quality mindset and a willingness to develop yourself and others.Proficient with Microsoft Office and Adobe AcrobatRequired Education and ExperienceAssociates degree in scientific discipline2-5 years of hands on experience with document management in a regulated industry-pharmaceutical or medical device industry-with direct document control experience.Preferred Education and ExperienceBachelor's degree in scientific disciplineAudit or inspection experienceDemonstrated knowledge of cGMP's, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.