What are the responsibilities and job description for the QA Specialist (Gene Therapy) position at BioSpace?
We are currently looking to fill a Quality Assurance Specialist (Gene Therapy) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This position is a desk-based compliance & quality position.
In this role, a typical day might include the following:
To be considered for this role you must hold a Bachelors degree and the following amount of relevant experience for each level:
#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)
$59,700.00 - $126,800.00
In this role, a typical day might include the following:
- Reviewing and approving master and executed batch records from Contract Manufacturing Organizations (CMO) manufacturing bulk drug substance including adeno-associated viruses (AAV), virus-like particles (VLPs), small interfering RNAs (si-RNA)
- Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Providing consultation or advice in alignment with QA policies and procedures
- Reviewing, editing, or approving Regeneron controlled documents
- Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials
- Performing status labeling of raw materials and product
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
- Excel in a quality driven organization
- Have an understanding of AAV, VLP, si-RINA or 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 Bachelors degree and the following amount of relevant experience for each level:
- Associate QA Specialist 2 years
- QA Specialist 4 years
- Senior QA Specialist - 6 years
#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)
$59,700.00 - $126,800.00
Salary : $59,700 - $126,800
