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

Absolutely required:

• Bachelor's degree
• Relevant experience as follows: Associate QA Specialist - 2+ years, QA Specialist - 4+ years, Sr QA Specialist - 6+ years

May substitute proven experience for education requirement.

Qualifications

• Quality-driven organization experience
• Understanding of VLP or si-RNA manufacturing operations
• Organized and detail-oriented
• Prioritization and changing priorities capability
• Ability to learn and utilize computerized systems

Skills

Not specified

Benefits

Not specified

Pay

$62,355.00 - $128,700.00 annually

Schedule

Not specified