QA Visual Inspection Specialist (Trainer)

We are currently looking to fill a QA Inspection Specialist Trainer 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 Training:

• Responsible for the visual inspection training program for QA AQL, which includes but is not limited to training program development, scheduling, program execution and training of new/existing hires for qualification/re-qualification and metrics reporting

• Kits and training kits

• Lead ongoing, daily departmental operations for the Qualification area

• Works with Visual Inspection QA team (specialists/facilitators) to build and maintain qualification

• Partners with Manufacturing and other internal groups to establish a philosophy for visual inspection and visual inspection qualification for the operators

• Partners with Technical Training to implement training and ensure all training is documented according to procedure.

• Reviews all SOP, policies, work instructions, batch records, etc. regarding Visual inspection training and qualification of inspectors.

• Develops QA documents for Visual inspection Training for AQL Inspection

• Works with QC Technical Resources and/or outside vendors to acquire qualification/training set defects

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 quality assurance 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 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 approach

This role may be for you if you:

• Have successfully 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 previous Visual Inspection experience of liquid and lyophilized products

• 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 Life Sciences 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.

#REGNQA

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)

$55,700.00 - $121,300.00