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Documentation Specialist

2 months ago

Minneapolis, United States Actalent Full time

Job Description Primary Duties:  Responsible for tasks associated with the processing of GXP documentation minimal supervision.  Aid in preparing, processing, and delivering quality GxP documentation to support areas.  Perform Business System Administrator Activities within the document management system. Additional Skills & Qualifications Responsibilities:  Provide direct support to Brooklyn Park site by performing duties as a Business System Administrator for the electronic document and learning management system.  Maintain system user status, process user requests, and assist users with system functionality learning.  Submit system enhancement and problem tickets when system issues or potential enhancements are found.  Process controlled documents in electronic document management system through editing and release approval stage.  Assign training to employees/contractors in electronic learning management system.  Issue controlled GMP Documentation to production areas including production records, controlled procedures, and laboratory test packets.  Maintain controlled documents and records by updating logs, databases, and spreadsheets.  Provide audit support for internal/external audits by fulfilling electronic document/learning management system reports.  Reconcile issued documentation periodically including batch records and controlled procedures and laboratory test packets to assure timely pick-up and return of documentation.  Demonstrate an understanding of control process and procedures, including electronic and hard copy format.  Work on assignments that are routine in nature with guidance from supervisor but can recognize when deviation from accepted practice occurs.  Utilize growing knowledge of internal procedures and practices to address issues that arise, assuring that supervisory guidance is requested when needed.  Ability to identify and resolve GDP issues using problem solving skills.  Complete mandatory training within required timeframe.  Perform additional tasks and duties as assigned. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.