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Documentation Associate Specialist

Irvine, California, United States
June 12, 2019


Job Description:

Science (Chemistry or Microbiology) background is preferred to be considered for this role. Please do not send in any candidates whom do not possess this required background experience unless they have excellent Documentation Background.

Computer skills specifically MS Word is a must.

Summary: The Master Specifications and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing), and Research and Development (all phases) and with our affiliates/contractor sites on possible "Change Control” related issues.

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.

• Assists in processing Product Launch Approvals (PLAs) and PLA Amendments as completed documents in CORAL.

• Effectively communicates (written and verbal) with colleagues at most levels of the organization to achieve timelines for project completion.

• Keeps project records organized to allow others within the Master Specifications and Documentation department to take over if necessary.

• Assists the Master Specifications and Documentation department as needed.

Required Knowledge and Skills

Knowledge of:

• Different computer software such as Microsoft Word, Excel, Access, Visio, Power Point, and Outlook preferred.

• 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.

Skill in:

• Project management – multiple projects and priorities. Detail and quality-oriented while at the same time, being an efficient and effective time manager using risk management.

• Interpersonal written and verbal communication skills.

• Organizational skills.

• Customer-oriented with sense of urgency of response to customer's needs.

• Detail oriented.

• Analytical thinking preferred.

Physical Requirements and Working Conditions:

Ability to work in an ergonomic office setting for most of the working day. Cognizant of others around them.

Minimum Qualifications:

• Two-year 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.