Quality Compliance Specialist (Complaints Investigation)

Location
Rensselaer, NY, United States
Posted
Sep 06, 2020
Ref
20128BR
Required Education
Bachelors Degree
Position Type
Full time
Summary

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 both internal and external records, design of experiments to test hypothesis and writes technical reports to support investigation conclusions. Compliance Operations inclusive of 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. Becomes involved as required to meet schedules or resolve problems.

Level to be determined based on qualifications relevant to the role

Essential Duties and Responsibilities include, but are not limited to, 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 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.
• Other related responsibilities as assigned.

Education and Experience
• Associate Specialist - Requires BS/BA in scientific discipline or related field with 1+ years of relevant work experience in pharmaceutical or related industry desirable.
• Specialist - Requires BS/BA in scientific discipline or related field with 5+ years of relevant work experience in pharmaceutical or related industry.
• Sr Specialist - Requires BS/BA in scientific discipline or related field with 8+ years of relevant work experience in pharmaceutical or related industry.
• Relevant experience may be substituted for educational requirement.

Level to be 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. #LI-DF1

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