BioSpace, Inc.
Associate Manager, Quality Assurance (MES)
BioSpace, Inc., Rensselaer, New York, United States, 12144
Job Details
We are currently looking to fill an Associate Manager, QA (MES) position. This position is responsible for supervising a team of QA employees and their prospective area(s) and/or assignments.
In this role, a typical day might include the following:Responsible for all aspects of QA MES Team including review and approval MES Manufacturing Batch Record (MBRs) and Equipment records (ESPs), for creation of new records or updates to current records.Approves various documents relating to area function, including those listed abovePrioritizes QA MES resources to meet goals and timings of MES implementation for specific products/process areas; coordinates prioritization of activities with Manufacturing and MES team management to adhere to targeted timelines for MES implementation/maintenance.Performs compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actionsReviews customer requirements and implements required processes, as needed, to meet customer expectations regarding QualityParticipates in regulatory and customer auditsThis role may be for you if you:
Have previous quality experience in the pharmaceutical industryYou continuously seek to improve processes for improved performanceEnjoy leading a team of Quality minded professionals
To be considered for this role you must hold a BS degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with 6+ years of experience in pharmaceutical or biologics manufacturing environment. Some supervisory and/or leadership experience preferred. May substitute proven experience for education requirement.
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 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 (annually)$89,100.00 - $145,500.00
We are currently looking to fill an Associate Manager, QA (MES) position. This position is responsible for supervising a team of QA employees and their prospective area(s) and/or assignments.
In this role, a typical day might include the following:Responsible for all aspects of QA MES Team including review and approval MES Manufacturing Batch Record (MBRs) and Equipment records (ESPs), for creation of new records or updates to current records.Approves various documents relating to area function, including those listed abovePrioritizes QA MES resources to meet goals and timings of MES implementation for specific products/process areas; coordinates prioritization of activities with Manufacturing and MES team management to adhere to targeted timelines for MES implementation/maintenance.Performs compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actionsReviews customer requirements and implements required processes, as needed, to meet customer expectations regarding QualityParticipates in regulatory and customer auditsThis role may be for you if you:
Have previous quality experience in the pharmaceutical industryYou continuously seek to improve processes for improved performanceEnjoy leading a team of Quality minded professionals
To be considered for this role you must hold a BS degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with 6+ years of experience in pharmaceutical or biologics manufacturing environment. Some supervisory and/or leadership experience preferred. May substitute proven experience for education requirement.
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 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 (annually)$89,100.00 - $145,500.00