We are currently looking to fill a QA Inspection Specialist position. This position supports Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility.
Available Working Schedules:
Monday-Friday, 2nd shift
In this role, a typical day might include the following:
Work on and potentially lead efforts to establish new programs to support Drug Product facility including start-up of formulation, filling, inspection, assembly, and pack and label team.
Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
Develop, write, review, and approve SOPs, specifications, and other documents to support drug product operations. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
Accountable for maintaining project timelines associated with quality assurance initiatives to support the evolving business
Oversee the Creation, Control and Maintenance of Visual Inspection Qualification Kits
Facilitates VI technician qualification, will be back up for VI AQL Inspectors
Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents (electronic and paper based)
Performs On-the- floor Visual Inspection Observation of Inspectors technique
Review and approval of documents including executed Batch Records and SOPs (electronic and paper-based)
Execute daily operations per management guidance in a dynamic environment.
Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
Provide guidance during on-the-floor manufacturing
Support audits, inspections and investigations.
Perform quarantine and segregation of material as needed
Performance of line clearances as required
Contribute to the continuous improvement culture
This role may be for you if you:
Excel in a quality driven organization
Have an understanding of 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
Have previous Visual Inspection experience
Have the ability to pass a visual acuity exam according to SOP requirements
To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and the following minimum amounts of relevant experience for each level:
Assoc Specialist – 2+ year
Specialist – 4+ years
Senior Specialist – 6+ years
May substitute proven experience for education requirement. Level is 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 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)