What are the responsibilities and job description for the Associate QC Micro Specialist position at Regeneron Pharmaceuticals Inc.?
As a AssociateQC Micro Specialist, a typical day might include the following:
- Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures.
- Authoring & Executing process area validations, environmental monitoring studies, and assisting on troubleshooting efforts (Investigations). All efforts may gain complexity overtime.
- Applies a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations.
- Collaborate with team members on activities associated with Change Control. This includes initiation, impact assessment, and implementation of the change; the initiation and closure of workflows and CAPAs.
- Authoring technical documents and studies to troubleshoot and support investigations.
- Applies their expertise in the creation and update of SOPs.
- Uses a knowledge of Data Integrity practices to perform evaluation of the practices of routine data entry, analysis, and reporting of microbiological data and support implementation of changes.
- Participates in internal audit discussions and seeks alignment with the team to address microbial requests.
- Collaborates in technical discussions and problem solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions.
- Seek support to make good judgements and quick decisions regarding microbiological methods.
- Assists in the integration of technical updates into the team procedures while maintaining compliance with regulatory agencies.
- Implements the creation and review of LIMS configurations to meet the needs of QC-Microbiology, this may include implementation of new specifications, design of LIMS/ELN templates for new/revised test methods, design of queries and reports.
This role might be for you if you:
- Assist in the development and support of strategies on how to achieve what needs to be done and develop metrics to measure the strategy.
- Have advanced knowledge in Microbiological Test Methods ( Environmental Monitoring, Water For Injection (WFI) Systems design and microbiological testing/program development, Pharmaceutical Grade Compressed Gas system design and microbiological investigation, Endotoxin, Bioburden testing) associated with Drug Substance, Drug Product, Raw Materials and Clean Utilities.
- Have the ability to handle multiple priorities with exceptional organizational and time management skills.
- Are Proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance).
- Can possess excellent written, verbal and interpersonal communication skills.
To be considered for the Associate QC Micro Specialist you must have a BS/BA in microbiology, biology or other related life sciences and 0-2 years of relevant experience.
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
Salary : $55,700 - $87,100
