Manager, QA Visual Inspection

We are currently looking to fill a Manager, QA Visual Inspection position. This position supervises and leads the QA AQL Visual Inspection Group and on the floor quality for visual inspection. Performs all tasks vital to establish and monitor the visual inspection AQL program for QA. This position is new to Regeneron and will be responsible for helping to hire the team that supports the Quality team that performs AQL Visual inspection and on the floor QA support for visual inspection.

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

• Responsible for Quality oversight of the Visual Inspection program at Regeneron and the team who oversees QA AQL:

  • Building and maintaining qualification kits

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

  • Responsible for building the training / qualification curriculum for QA AQL Specialist

  • Collaborates with DP MFG to develop the program for classification of rejects and AQL levels

  • Participates in equipment design, and startup of VI automated equipment and manual/semi- manual visual inspection start up.

  • Supports implementation / qualification of automated inspection processes

  • Reviews all SOP, policies, work instructions, batch records, etc. regarding Visual inspection, defects, rejects, and defect kits.

  • Develops QA documents for Visual inspection AQL Inspection

  • Quality Specialist and reviewer/approval for visual inspection deviations, change controls, CAPAs, etc.

  • Completes training and maintains required qualifications for visual inspection

  • Responsible for performing QA line clearance for visual inspection area and audits of the fill/finish area

  • Analyze and trends AQL defects, provides metrics; and presents KPIs.

  • Reviews and approves process generated data from Manufacturing visual inspection

• Accountable for the performance and results of a team.

• Provide career development and training advice and set short term and long term goals for the team.

• Develops strategy on how to achieve the work that needs to be completed

This role may be for you if you:

• Are able to pass a visual acuity exam according to SOP requirements

• 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

• Possess proven strong interpersonal, cross- cultural, communication, negotiation and problem-solving skills

• Exhibit confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness

• Understand and listen to team members and stakeholders’ needs while supporting a positive team environment

• Have 2+years of experience leading and developing a team.

To be considered for this role you must hold a BA / BS degree in a physical or biological science the following minimum amounts of relevant experience for each level:

• Associate Manager – 6+ years

• Manager – 7+ years

• Sr Manager – 8+ 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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