Orange County Metro Area, CA
The department is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.
The Master Specifications and Documentation department also provides services which include the word processing/routing/approval and subsequent maintenance of SOPs and forms/templates, and maintenance of reference documents in the EDMS document repository system. Reference documents include Product Launch Approvals (PLAs), validations and qualifications, and archived Master QA and Manufacturing Batch Records documents.
Services provided by the Master Specifications and Documentation department are specifically tailored to the characteristics of the products, needs of the customers, Quality and Company guidelines, and ISO 13485 and FDA/MOH Regulatory requirements.
Essential Job Functions:
This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
Coordinates and processes all Master Specifications and Documentation-managed documents through the Change Control process/system with supervision as necessary. Uses Microsoft Word for Product Spec updates. Established timelines are kept and monitored through the department project tracking system.
Assists with word processing Master Specifications and Documentation SOPs as needed. .
Computerized systems such Documentum, Trackwise, and SAP preferred but not required.
General cGMP, ISO, and FDA Requirements preferred but not required.
General knowledge of pharmacopeias preferred but not required.
Degree: Science, Chemistry or Biology and/or related field preferred.
Two to four years related experience. Working in a laboratory environment in a pharmaceutical, medical device or related industry including Quality Assurance preferred.