We are currently looking to fill a Sr QA Specialist position supporting our new fill finish facility. This position will be responsible to ensure that materials used in manufacturing are of the appropriate quality to ensure the production of drug products meeting or exceeding expectations.
In this role, a typical day may include the following :
Represent Quality Assurance in support of complex and / or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution,
Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.
- Train and / or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization;
- Provides consultation or advice in alignment with QA policies;
Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.
Activities may be on the floor or at a desk
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with raw materials, product, laboratory, facilities, or materials
Evaluates a variety of Supplier documentation for adequacy
Evaluates internal and external changes to determine acceptability
Prepares and reviews protocols and summary reports for the qualification of materials (raw materials, and drug product and medical device components)
Manages and tracks projects to ensure milestones are achieved while complying with established timelines
Supports the resolution of internal and external deviations, and Supplier Corrective Action Requests (SCARs) related to materials
This role may be for you if you :
Understanding of biologics manufacturing operations is preferred
Good organizational skills and attention to detail
Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
Ability to handle multiple assignments and changing priorities.
Ability to learn and utilize computerized systems for daily performance of tasks
Ability to prioritize, manage multiple tasks, and meet deadlines
Ability to stand for periods of time when performing tasks on the floor (Raw Materials).
Ability to work a varied schedule including off shift and weekends.
To be considered for this role you must hold a Bachelor’s degree in a scientific discipline or related field and the following minimum amounts of relevant experience for each level :
Senior Specialist 6+ years
Principal Specialist 8+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
REGNQA
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