Quality Compliance Specialist (Complaints)

We are currently looking to fill 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. This position conducts forensic review of evidence and both internal and external records, design of experiments to test hypothesis and writes technical reports to support investigation conclusions. Compliance Operations are inclusive of, but not limited to, Manufacturing (Internal and External), Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling and QA Validation, in accordance with mandated regulatory requirements and site expectations. This position acts as an advisor to these groups on how to maintain and improve compliance and becomes involved as required to meet schedules or resolve problems. 

In this role, a typical day might include the following:

• Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities and materials management.

• Conducts investigations related to dissatisfaction in product quality or performance by end user related to commercial and clinical products. 

• Researches complaints documentations, photograph evidence and evaluates return samples available to support complaint investigation.

• Supports investigations and/or product complaints with focus on Root Cause Analysis (RCA).

• Generates technical reports related to investigative findings, with supporting evidence.

• Actively participates in company continuous improvement initiatives.

• Participates in regulatory and customer audits.

• Identifies gaps in systems and develops feasible plans for correction.

• Other related responsibilities as assigned. 

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 hold a Bachelor’s degree in scientific subject area or related field with the following amount of relevant work experience in pharmaceutical or related industry:

• Specialist – 2+ years

• Senior Specialist – 5+ years

• Principal Specialist– 8+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

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)

$63,500.00 - $141,900.00