Regeneron Pharmaceuticals
Quality Compliance Coordinator (Complaints)
Regeneron Pharmaceuticals, East Greenbush, New York, United States, 12061
The Quality Compliance Coordinator acts as initial point of contact for receiving and processing complaint samples. They receive and process returned complaint samples and perform examination of complaint and reserve samples. They will also maintain compliance with site procedures and become involved as required to meet schedules or resolve problems.
In this role, a typical day may include the following:
Monitor complaint notifications from group mailbox
Enter complaint intake data into Process Compliance system and Complaint Master tracking sheet
Verify required documentation and content received
Evaluate and assign initial classification of event or complaint
Correspond with personnel and contractors (Call Center, Regeneron Distribution, Clinical Trial Management, etc.) as the need arises to request or obtain additional information related to complaint reports
Process receipt of complaint samples
Examine and evaluate complaint and retain samples for defects
Acquire photographic evidence, record sample data, enter observations and evidence into LIMS
Process complaint samples for destruction
Assist with delivery of complaint samples to QC for testing
Retrieve, copy/scan and maintain batch documentation used to support complaint investigations
Perform general administration activities in support of the complaint team
This role may be for you if you:
Excel in a quality driven organization
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 BS/BA in scientific discipline or related field and the following minimum amounts of experience for each level:
Quality Compliance Coordinator: 0-3 years
Relevant experience may be considered in lieu of degree.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly)
$24.76 - $38.70
In this role, a typical day may include the following:
Monitor complaint notifications from group mailbox
Enter complaint intake data into Process Compliance system and Complaint Master tracking sheet
Verify required documentation and content received
Evaluate and assign initial classification of event or complaint
Correspond with personnel and contractors (Call Center, Regeneron Distribution, Clinical Trial Management, etc.) as the need arises to request or obtain additional information related to complaint reports
Process receipt of complaint samples
Examine and evaluate complaint and retain samples for defects
Acquire photographic evidence, record sample data, enter observations and evidence into LIMS
Process complaint samples for destruction
Assist with delivery of complaint samples to QC for testing
Retrieve, copy/scan and maintain batch documentation used to support complaint investigations
Perform general administration activities in support of the complaint team
This role may be for you if you:
Excel in a quality driven organization
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 BS/BA in scientific discipline or related field and the following minimum amounts of experience for each level:
Quality Compliance Coordinator: 0-3 years
Relevant experience may be considered in lieu of degree.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly)
$24.76 - $38.70