Supervisor, Quality Assurance (Shop Floor)
BioSpace, Troy, NY, United States
Regeneron is currently looking for a Sr Quality Assurance Specialist (Supervisor) position. This position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
Work Schedules
Wednesday-Saturday, 1st shift, 6am-4:30pm
In this role, a typical day might include the following:
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Supervising direct reports
Participates with employee training to ensure that all requirements are met.
Performs, minimally, monthly performance feedback meetings with direct reports.
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 stand for periods of time when performing tasks on the floor
Gowning And Environment
Full cleanroom attire (Examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for this role you must hold a Bachelors degree and 6+ years of relevant experience. May substitute proven experience for education requirement.
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 Regenerons roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regenerons 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.
Salary Range (annually)
$78,700.00 - $128,700.00
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Work Schedules
Wednesday-Saturday, 1st shift, 6am-4:30pm
In this role, a typical day might include the following:
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Supervising direct reports
Participates with employee training to ensure that all requirements are met.
Performs, minimally, monthly performance feedback meetings with direct reports.
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 stand for periods of time when performing tasks on the floor
Gowning And Environment
Full cleanroom attire (Examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for this role you must hold a Bachelors degree and 6+ years of relevant experience. May substitute proven experience for education requirement.
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 Regenerons roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regenerons 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.
Salary Range (annually)
$78,700.00 - $128,700.00
#J-18808-Ljbffr