This position will be responsible for supporting the operation and upkeep of the Computerized Maintenance Management System (CMMS) and Master Equipment File (MEF) by performing detailed inspections in support of GMP equipment management. The core function consists of performing day to day CMMS and EMS record quality checks.
Detailed Duties and Responsibilities:
This position provides support for the CMMS and MEF systems in support of GMP Equipment management:
Performing daily secondary review of electronic records making sure that the records comply with current standard operating procedures Performing active asset audits in the MEF Scanning and renaming files in the eMEF Archive paperwork from the MEF.
- Position requires AA diploma or equivalent job experience and 0 to 2 years experience in the pharmaceutical/biotechnology industry.
- This position requires superior computer skills with MS Word, Excel, Adobe.
- Requirements also include superior attention to detail and organizational skills, excellent grammatical and proofreading skills, proven multi-tasking abilities, immediate response action to tasks and personnel requests for assistance, strong interpersonal and communication skills, and ability to handle changing priorities if needed in a fast-paced environment.
- Basic knowledge of cGMP and GLP regulations for documentation practices is highly desired.
- The successful candidate will be able to maintain a high degree of confidentiality and professionalism and be able to work well with employees at all levels of skill and authority throughout company.
- Desired qualifications include an Associates degree in a related field, such as computer processing, and experience utilizing a validated Computerized Maintenance Management System (CMMS).