Quality Assurance Associate, Floor; 2nd shift

Quality Assurance Associate, On the Floor (OTF)

Shift: 2nd shift 4PM–2:30AM

• Support Process Teams by tracking/reporting and defining continuous improvement goals.
• Review on-the-floor batch records; determine root cause for deviations; write investigation reports.
• Coach/train personnel on GMP/GDP.
• Audit production processes for compliance with global and local procedures.
• Review/approve product batch records and technical documentation for validation, deviations, and change control (e.g., media fills).
• Track/report and define continuous improvement goals; determine root cause for deviations/CAPA reports and communicate back to the Process Team.
• Create new or revise existing procedures as changes occur.
• Develop training plans and train/qualify others (including training outside area of responsibility).
• Provide input/approval based on understanding of regulations for various countries.

• Associate’s degree in a science-related field with relevant industry experience, or Bachelor’s degree in a science-related field (e.g., Biology, Chemistry).
• Previous experience with USDA/FDA regulatory requirements in a biological production environment.
• Experience with computer programs such as Microsoft suite, SAP, Veeva, Learning One Source, and other relevant electronic applications.

• Ability to make product acceptability decisions with minimal supervision based on documentation.
• Excellent attention to detail.
• Strong professionalism with internal and external customers.
• Ability to formulate ideas to improve site performance/efficiency and implement collaboratively.

• Multiple relocation packages (eligible positions)
• Two weeklong shutdowns in the US (mid-summer and year-end) in addition to PTO
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401K matching