QA Specialist (Oligonucleotides/VLPs)

About the role

This position supports dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Responsibilities

• Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing bulk drug substance including VLPs and small interfering RNAs (si-RNA)
• Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Providing consultation or advice in alignment with QA policies
• Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.)
• Reviewing, editing, or approving Regeneron controlled documents
• Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials
• Performing status labeling of raw materials and product
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

Requirements

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Qualifications

• Associate QA Specialist – 2+ years
• QA Specialist – 4+ years
• Sr QA Specialist - 6+ years

Skills

Excel in a quality driven organization
Have an understanding of VLP or si-RNA manufacturing operations
Be organized and have an attention to detail
Prioritize multiple assignments and changing priorities
Be able to learn and utilize computerized systems for daily performance of tasks

Benefits

See details in the job description.

Pay

$62,355.00 - $128,700.00 annually

Schedule

See details in the job description.