The Quality Compliance Specialist (Complaint Investigations) maintains site compliance of operations focused primarily on investigation of product quality complaints received for commercially distributed and clinical products. This role 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.
Your day to day could include, but are not limited to, the following:
Education and Experience:
- Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities, and materials management; act as an advisor to these groups of how to maintain and improve compliance.
- Conducts investigations related to dissatisfaction by end user related to commercial and clinical products.
- Research complaints documentations, photograph evidence and evaluate return samples in available to support complaint investigation.
- Generate technical reports related to investigative findings, with supporting evidence.
- Participates in regulatory and customer audits.
- Identify gaps in systems and develop feasible plans for correction
- Actively participate in continuous improvement initiatives.
- Associate Specialist: Requires BS/BA in subject area or related field. 1-3 years of relevant work experience in pharmaceutical or related industry desirable.
- Specialist: Requires BS/BA in scientific subject area or related field with 5+ years of relevant work experience in pharmaceutical or related industry.
- Senior Specialist: Requires BS/BA in scientific subject area or related field with 8+ years of relevant work experience in pharmaceutical or related industry.
- Relevant experience may be substituted for educational requirement.
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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