Document Control Specialist

Company: Bell International Laboratories, Inc
Location: Saint Paul
Posted on: August 4, 2022

Job Description:

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.Responsibilities Perform 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.Required Skills/Abilities Knowledge of laboratory equipment set-up and operation, common laboratory techniques and safe chemical handling Proficient 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 AcrobatRequirementsRequired Education and Experience Associates 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 Experience Bachelor's degree in scientific discipline Audit 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.

Keywords: Bell International Laboratories, Inc, St. Paul , Document Control Specialist, Other , Saint Paul, Minnesota