Quality Compliance Specialist (Complaints)

Regeneron Pharmaceuticals • Rensselaer, IN

1d • Onsite

About The Position

Regeneron is currently looking for a Quality Compliance Specialist (Complaints) position. This position maintains site compliance of operations focused primarily on investigation of product quality complaints received for commercially distributed and clinical products. Conducts forensic review of evidence and records, design of experiments to test hypothesis and writes technical reports to support investigation conclusions. Compliance Operations including but not limited to Manufacturing (Internal and External), Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, QA Validation in accordance with mandated regulatory requirements and site expectations. Acts as an advisor to these groups of how to maintain and improve compliance. As a Quality Compliance Specialist, a typical day might include the following: Ensuring aspects of Quality Compliance for the site including manufacturing, quality control, validation, facilities, and materials management Conducting investigations related to dissatisfaction by end user related to commercial and clinical products Researching complaints documentations, photograph evidence and evaluate return samples to support complaint investigation Generating technical reports related to investigative findings, with supporting evidence Participating in regulatory and customer audits Identifying gaps in systems and develop feasible plans for correction Actively participating in continuous improvement initiatives This role may be for you if you: Are experienced in pharmaceutical or medical device complaint investigation Have an understanding of biologics manufacturing operations Are organized and have an 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 be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences or related field. For various levels you must have the following: Quality Compliance Specialist: 2+ years Sr. Quality Compliance Specialist: 5+years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $67,400.00 - $128,700.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Requirements

• Are experienced in pharmaceutical or medical device complaint investigation
• Have an understanding of biologics manufacturing operations
• Are organized and have an 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 be willing and able to work Monday-Friday, 8am-4:30pm.
• You must have a BS/BA in Life Sciences or related field.
• Quality Compliance Specialist: 2+ years
• Sr. Quality Compliance Specialist: 5+years
• May substitute proven experience for education requirement.

Responsibilities

• Ensuring aspects of Quality Compliance for the site including manufacturing, quality control, validation, facilities, and materials management
• Conducting investigations related to dissatisfaction by end user related to commercial and clinical products
• Researching complaints documentations, photograph evidence and evaluate return samples to support complaint investigation
• Generating technical reports related to investigative findings, with supporting evidence
• Participating in regulatory and customer audits
• Identifying gaps in systems and develop feasible plans for correction
• Actively participating in continuous improvement initiatives

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level