QA Inspection Specialist (Drug Product)

Location
East Greenbush, New York, United States of America
Posted
Jul 23, 2021
Ref
R1177
Required Education
Bachelors Degree
Position Type
Full time
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.

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


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 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.