This position will be responsible to administer, coordinate, maintain and secure controlled documents to ensure process and product related documentation meets operational needs and conforms to company standards as part of the change control process. The change control process encompasses changes in documentation, equipment, facility, specifications and test methods. This indivdual will be responsible for coordinating the implementation and documentation of changes with quality assurance, manufacturing and regulatory.
This position will also be responsible for the company training program, as well as, generating all new hire cGMP training files and conducting New Hire Orientation training.
Maintain the document control system consisting of product and process related documenation, such as, batch records, SOPs, test methods and specifications.
Write and revise Standard Operating Procedures (SOPs) as required.
Bi-lingual Spanish/English is preferred
4 years of experience in regulated industry, such as pharmaceutical, Medical Device or biotechnology
Possess a considerable knowledge of cGMPs and SOPs
Strong computer skills and must be proficient in Microsoft Office, WORD, EXCEL, Power Point and Outlook
Demonstrate ability to work effectively in a team environment, manage multiple priorities, exercise sound judgement, be well organized, take initiative and produce accurate and timely work.