QA Inspection Specialist (Qualification)

We are currently looking to fill a QA Inspection Specialist (Qualification Facilitator) 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.

In this role, a typical day might include the following:

Visual Inspection Qualification Facilitator:

• Responsible for qualification preparation, including but not limited to documentation readiness, qualification/training kit readiness and scheduling for initial and annual requalification of visual inspectors and qualification kits

• Responsible for coordinating and reviewing progress of inspectors on evaluation assessments and qualification trials and conducting the evaluation of inspectors after qualification completion

• Provide formal instructions according to SOP/Protocol to a group of inspectors in a qualification setting

• Coordinate/supervise qualification room and ensures the environment for inspectors is efficient for qualification activities

• Oversee/monitor inspection methods and inspector adherence to protocol and procedures during qualification activities

• Maintains confidentiality and security of all qualification materials, logbooks, and other documentation as applicable

Facility Start Up:

• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of 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 initiatives to support the evolving business

Operations:

• 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)

• Complete daily operations per management mentorship in a multifaceted environment

• Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards

• Provide mentorship during on-the-floor manufacturing

• Support audits, inspections and investigations

This role may be for you if you:

• Have knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products

• Are experienced using and / or developing qualification kits and qualifying operators

• Have optimally developed and implemented employee training programs

• 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 use computerized systems for daily performance of tasks

• Have the ability to pass a visual acuity exam according to SOP requirements and are able to gown for an “A” classification

To be considered for this role you must hold a Bachelor’s degree in a scientific subject area or related field and the following minimum amounts of relevant experience for each level:

• Associate Specialist – 2+ years

• 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 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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