Associate Director QA Microbiology

We are currently looking to fill an Associate Director QA Microbiology position. This position focuses on supporting the improvement of practices and procedures that ensure the efficiency of the Contamination and Microbial control programs. Also assess, justify and support the implementation of new technologies to help support product safety. In addition, this position will support the goal of zero regulatory observations by partnering with the Inspection Management Team (IMT) with inspection preparations and regulatory inspections.
In this role, a typical day might include the following:
• Improving upon and maintaining the general facility bioburden program and remediation efforts
• Leading investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination and remediation plans
• Maintaining industry standards with respect to microbial control and mitigation - incorporate any new industry standards/use of new monitoring equipment
• Providing input on technology transfer plans related to microbiological method transfers (method validation)
• Developing and providing input on the development and modification of microbial action limits
• Reviewing and providing input on microbiology SOPs, microbiology assay validation and related documentation
• Reviewing and providing input on environmental monitoring SOPs and validation
• Reviewing and providing strategic support to understanding and managing bioburden trend levels
• Assessing the efficiency of sanitization agents
This role may be for you if you:
• Have knowledge and experience in qualifying clean rooms, clean utilities and manufacturing processes
• Have experience in quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals
• Excel in a quality driven organization
To be considered for this role you must hold a Master's or Bachelor's degree in a microbiology, medical technology, biology or related field and a minimum of 10 years experience in the pharmaceutical or biotechnology industry. Level to be determined based on qualifications relevant to the role.
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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