QC Compliance Specialist (Microbiology Investigations)

Location
Rensselaer, NY, United States
Posted
Sep 11, 2020
Ref
19725BR
Required Education
Bachelors Degree
Position Type
Full time
Summary:
Responsible for assisting Quality Control laboratories with investigations, deviations, method changes and document workflows as needed by specific functions including Chemistry, Bioassay, Microbiology and Virology.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Ensure that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
• Lead and participate directly in the investigation process.
• Write and/or review investigation reports.
• Contribute in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions.
• Assist in the execution of Corrective & Preventative Actions and ensure they are appropriate, effective, and are implemented as planned in a timely manner.
• Identify recurring events and trends within Quality Control's deviations and propose continuous improvement ideas based on findings.
• Keeps team members informed of the status of assigned work.

Education and Experience:
• Assoc Specialist: BS/BA in chemistry, biology or related field
• Specialist: BS/BA in chemistry, biology or related field with 2 years of experience in quality control/analytical sciences including minimum of 1 year of experience leading lab investigations in a cGMP environment
• Sr Specialist: BS/BA in chemistry, biology or related field with 5 years of experience in quality control/analytical sciences including minimum of 1 year of experience leading lab investigations in a cGMP environment
• Or equivalent combination of education and experience

*Level to be determined based on skills and related experience*

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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