As a Lead QC Micro Analyst you will perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Lead-Related Activities include, but are not limited to, the following:
• Provide on-the-floor guidance and support to employees.
• Ensure employees timesheets are completed on time.
• Monitor employees training to ensure that all requirements are met, including OJT.
• Maintain up to date training records for self and direct reports.
• Perform monthly performance feedback meetings with direct reports.
• Escalate all performance issues to management and/or HR.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Microbiology representation and participation in cross functional site meetings.
- Administration of programs such as gowning, training, ordering, calibration, etc.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
- Participate in training of other new employees and prioritizes workloads on a daily basis.
- Perform peer review of data.
- Perform laboratory investigation reports.
- Perform microbial identification procedures.
- Maintain laboratory supplies, media, and reagents inventory.
- Participate in the overtime and weekend schedule as required.
- Perform bioburden and endotoxin testing of products and raw materials.
- Perform microbiological testing of in-process and final product materials.
- Perform biological and endotoxin indicator testing used in the validation of manufacturing equipment.
- Update microbiological environmental monitoring results database and prepares monthly report.
- Perform acceptance testing of commercially prepared microbiological culture media.
- Assist in coordinating equipment maintenance and calibration.
- Perform all duties relevant to the Quality Control Microbiology Analyst position as required.
To be considered for this role you should have a BS/BA in Microbiology or related field and 1+ years of relevant experience. Or equivalent combination of education and 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.