Documentation Specialist

3 weeks ago

Warrendale, Pennsylvania, United States Fresenius Kabi Full time

Reference #:
R011190 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.

Responsibilities

Maintain files (Filing Master, history files and artwork). Issue document numbers. Create and maintain document indexes. Provide clerical work (i.e. 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 adhere to document control procedures.

Support customer complaint investigation Supports label proof approval and first article approval Handle problems, routine in nature, using established processes and procedures.

Other duties as assigned.


All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

High School Diploma/GED Ability to work on a team is essential. Possess effective writing and verbal communication skills, in addition to personal conflict resolution skills. Ability to notice errors in documentation and filing, and to take appropriate corrective actions. Must be detail oriented and able to multitask. Handle problems routine in nature using establish processes and procedures. Able to make judgments based on past experiences, established practices, and procedures. Ability to read and understand SOPs, GDPs, and Configuration manuals. Must be able to prioritize multiple projects and tasks.

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 match, 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.

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, disabilities, or protected veteran status.

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