Quality Assurance Associate, On the Floor (Off Shift)

Role Summary

Quality Assurance Associate, On the Floor (Off Shift)

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 subsequent communication back to the Process Team.
• Audit production processes for compliance with global and local procedures and either create new or revise existing procedures as changes occur.
• Develops 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 relevant scientific discipline and a minimum 2 years of relevant experience in quality assurance or biological production OR High School Diploma/GED with a minimum 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: Previous experience utilizing computer programs such as Microsoft 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 provided.
• Preferred: Excellent attention to detail.
• Preferred: Continuously demonstrates a high level of professionalism through interactions with internal and external customers.
• Preferred: Must be capable of formulating new ideas for improving site performance and efficiency and working cohesively with all levels to implement ideas.

Skills

• Quality assurance
• Regulatory compliance
• Root cause analysis
• Training and development
• Documentation and record review

Education

• Bachelor‚Äôs degree in a relevant scientific discipline or equivalent experience as specified in requirements.

Additional Requirements

• Shift: Flexible based on availability, but will cover some 2nd and 3rd shift hours Monday-Friday.