What are the responsibilities and job description for the QA Documentation Specialist position at Regeneron Pharmaceuticals Inc.?
We are currently looking to fill a QA Documentation Specialist to support the site(s) documentation system and ancillary support systems. This role will support Document Control or Records Management group efforts that aim to improve document integrity, writing and communication. The Specialist will work on both daily tasks and project tasks, and work with management to assess and improve programs and processes. The role will focus on one or more areas of the group’s business, such as reviews, training, records management or global alignment and improvement.
As a QA Documentation Specialist, a typical day might include the following:
Provides guidance, mentoring and training to Document Control or Records Management staff and user departments in proper use of the document/record management systems.
Develops and oversees the creation of tools, resources, and programs to improve document/record quality and promote good writing.
Collaborates with management to continuously assess and adjust programs and processes.
Coordinates review and revision of controlled documents, inclusive of other sites.
Balances both daily tasks and a project-based workload and may oversee related activities and the work of project contributors.
Assists with leading initiatives that broaden the impact of the group and help improve writing, document integrity and communication across the sites.
Develops proposals and strategies related to future-planning and growth of the group.
Focuses on one or more areas of the group’s business, such as reviews, training, or outreach for internal, cross-functional, and global awareness of initiatives, improvements, and process changes.
Prepares metric reports for management.
May coordinate document/record requests and stage documents for presentation during regulatory inspections.
May oversee and/or lead investigation activities and manage compliance items for department.
May review/approve changes in accordance with SOPs
May lead projects.
May oversee the revision of documents for proper grammar, spelling, punctuation, presentation, etc., and to improve clarity, syntax, logic, flow, organization, etc.
This role may be for you if:
Excel in a quality driven organization
Are organized and have a high level of attention to detail
Can prioritize multiple assignments and changing priorities
Are able to learn and utilize computerized systems for daily performance of tasks
To be considered for this role you must hold a BS/BA degree in related field and the following amount of relevant experience in QA/Document Control/Records management for each level:
Specialist – 2 years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
Salary : $65,100 - $106,300
