Product Specification Specialist

Location
Rensselaer, NY, United States
Posted
Feb 27, 2021
Ref
22747BR
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a position as a Product Specification Specialist. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Product Specification Specialist helps our mission through supplying and coordinating the content of product specification documents by collaborating cross-functionally and working within Regeneron's quality systems to build and maintain these controlled documents.

As a Product Specification Specialist, a typical day might include the following:
• Initiating, revising, or retiring product specifications while keeping compliant with site procedures.
• Collaborating with cross-functional departments to understand the content to be included in new and revised documents.
• Working with associated departments to resolve impact of the changes to documents and conduct quality risk management assessments to identify failure modes and risk controls.
• Collaborating with appropriate personnel to ensure product specifications are consistent with current regulatory filings and commitments.
• Being responsible for and assigning projects or tasks to other specification specialists.
• Identifying project issues and contributing to development of alternate strategies.
• Utilizing expertise to assist in the investigation of deviations involving product specifications.

This role might be for you if you are:
• Self-motivated and can effectively prioritize and lead work responsibilities at an independent level.
• Effective with time management and project management
• Able to multitask and take care of rapidly changing priorities (a must for the position).
• Able to meet deadlines.
• An effective public speaker and encompass good interpersonal, written, and oral communication skills in cross-functional department meetings.
• Proficient with MS word, PowerPoint, Excel, and are able to learn and navigate document management software.
• A team player.

To be considered for the Product Specification Specialist you must have the following; BA/BS degree preferably in a scientific related field, with 0-2 years relevant experience at Associate Specialist level, 2+ years of relevant experience at Specialist level and 5+ years of relevant experience at Senior Specialist level. Experience with or knowledge of biopharmaceutical testing or manufacturing is preferred and knowledge of USP/EP compendia requirements and ICH guidelines a plus. Relevant experience may be substituted for education requirement. Level is determined based on qualifications relevant to the role

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.