Quality Compliance Specialist (Complaints)

Rensselaer, NY, United States
Nov 19, 2020
Required Education
Bachelors Degree
Position Type
Full time
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. 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.

In this role, 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 hold a Bachelor's degree in scientific subject area or related field with 1+ years of relevant work experience in pharmaceutical or related industry level for Associate Specialist level, 5+ years experience for Specialist level, and 8+ years experience for Senior level. 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 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.