Quality Assurance Associate, On the Floor (Off Shift)

Role Summary

Quality Assurance Associate, On the Floor (OTF). This role supports the Process Teams by tracking and reporting continuous improvement goals, on-the-floor batch record review, determining root cause for deviations and investigation report writing, coaching and training personnel on GMP/GDP, auditing production processes for compliance with global and local procedures, and reporting to the Process Team Lead and Quality Lead. Shift: Flexible based on availability, but will cover some 2nd and 3rd shift hours Monday-Friday.

Responsibilities

• Review and approve product batch records and technical documentation associated with validation, deviations or change control activities (media fills, etc.).
• Track, report, and define continuous improvement goals; determine root cause for deviation/CAPA reports, and communicate back to the Process Team.
• Audit production processes for compliance with global and local procedures; create new or revise existing procedures as changes occur.
• Develop training plans and trains/qualifies others, including training outside of area of responsibility.
• Demonstrates understanding of regulations for various countries and provides input or approval accordingly.

Qualifications

• Required: BS degree in a relevant scientific discipline with at least 2 years of relevant experience in quality assurance or biological production, or a High School Diploma/GED with at least 5 years of relevant experience in quality assurance or biological production.
• Required: Previous experience with USDA/FDA regulatory requirements in a biological production environment.
• Required: Experience utilizing computer programs such as Microsoft Office suite, SAP, Veeva, Learning One Source and other relevant electronic applications.
• Preferred: Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation.
• Preferred: Excellent attention to detail.
• Preferred: Professionalism in interactions with internal and external customers.
• Preferred: Ability to formulate new ideas for improving site performance and efficiency and to work with all levels to implement ideas.