We are currently looking to fill a Quality Systems Specialist. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Quality Systems Specialists work within the QA Change Control Team to facilitate process improvements, ensure training of end users, and support the Quality Management System.
As a Quality Systems Specialist, a typical day might include the following:
- Developing and leading training for end users
- Partnering with other members of the Quality Assurance team and/or end users to identify, develop, and implement continuous improvements
- Work with end users in understanding business needs and crafting creative solutions.
- Developing, monitoring, and communicating metrics to ensure the health of the Change Control System
- Assisting as needed in audits and inspections
- Reviewing and approving of Change Proposals as required
This role might be for you if:
- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
- Proven track record to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven record of shifting thought processes quickly from one task to another.
- Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
- Consistent record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
- Possess excellent interpersonal, written and oral communication skills
- Ability to utilize active listening skills to understand concerns or reasoning in order to build strategic relationships
- Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred
To be considered for the Quality Systems Specialist you must have the following; BA/BS degree in a scientific or engineering discipline or related field and experience in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements. At Associate level 0 -2 years of industry/relevant experience, 2-5 years experience at Specialist level or 5+ years experience at Senior Specialist level. 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.
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