New

Documentation Specialist

Fresenius Kabi USA, LLC
life insurance, 401(k)
United States, Pennsylvania, Warrendale
770 Commonwealth Drive (Show on map)
May 06, 2025
Job Summary Under direct supervision, provide clerical and administrative support for documentation system under cGMP and support the Quality System. Issue and control documents according to established procedures. Administer document routing and review process. Research and collate file records as needed. May also operate a desktop computer using word processing software. Fill document requests. Pay Range: $18.00-21.00 per hour. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities Maintain files (Filing Master, history files and artwork). Issue document numbers. Create and maintain document indexes. Provide clerical work (e.g., fax and copy documents) Fill document copy requests. Assign quality numbers. Retrieve quality records. Perform final quality release of production units. Perform quality support activities, such as performing production containment activities Provide administrative and other support such as document research requests, scanning, and archiving records and adheres to documents control procedures. Support customer complaint investigation Support label proof approval and first article approval Job Requirements:* Ability to notice errors in documentation and filing, and to take appropriate corrective actions. Ability to read and understand SOPs, GDPs, and configuration manuals. Must be detail-oriented and able to multitask. Effective oral and written communication skills and personal conflict resolution skills. Able to make judgments based on past experiences, established practices, and procedures. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.