Overview
We are seeking an experienced QA Documentation Management Associate, which is a contract position, to join our team. This role is crucial for ensuring quality oversight of our local and global procedural document program.
Responsibilities
Review and Perform Quality Check (QC) of Global and Local Procedural Documents and Training:
Perform Quality Check of local and global Procedural Documents (SOPs, Work Instructions, Forms, etc.), including review for format, reading comprehension, spelling, and language.
Review quizzes against associated Procedural Documents, including ensuring that quiz wording matches the associated procedural document and review for clarity.
Liaise with colleagues regarding revised quizzes and training.
Liaise with current Document Manager regarding QC on Procedural Documents.

General Quality Document Management Compliance:
Assist with maintaining a manual backup system for controlled Procedural Documents (Business Continuity Plan).
Physically file local Procedural Documents within the office, and file both local and global Procedural Documents electronically on SharePoint.
Audit local and global document folders on SharePoint to ensure accuracy.
Assist with updating user profiles in the electronic documentation management system
Route local documents for review and approval within the electronic documentation management system
Track workflows of controlled documents to ensure on time periodic reviews and assist where needed for completion of reviews and approvals.
Release approved documents for training.

Creation of Training for Local Documents
Create quizzes for local Procedural Documents, as needed, and liaise with document authors regarding training.

Minimum Requirements:
Associate's degree in a scientific, technical, social, life sciences, library science, English or a related field but not required with applicable experience.
Minimum of 3 years of experience in a QA/quality, clerical or controlled documentation role in a pharmaceutical/life sciences environment.
Strong working knowledge and skills with Microsoft Word and Excel, especially with formatting.

Preferred Skills and Qualifications:
BA/BS in a scientific, technical, social, life sciences, library science, English or a related field.
Strong attention to detail, technical writing skills, excellent communication skills, strong critical thinking skills, and effective problem-solving abilities.
Knowledge of documentation control systems.
Prior experience in pharmaceutical, biotech, medical devices or life science environment.
Working knowledge of GMP regulations and guidelines, especially related to document control and document management.
Experience with an electronic Document Management Systems, preferably Veeva.

ESSENTIAL PHYSICAL REQUIREMENTS
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Ability to travel via automobile and/or airplane.
Ability to view video display terminal images
Ability to operate a computer keyboard and telephone.
Ability to sit for extended periods of time - up to four (4) hours at a time.
Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity.We look forward to reviewing your resume & qualifications. DISCLAIMERThe job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.


Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity