QA Production Support
About the role
This position provides real-time quality oversight with a 60% daily presence on the manufacturing floor, performing in-process batch record reviews, cleaning log reviews, and pre-process checks. You will partner with operations to identify and address quality concerns "in the moment," coach personnel on GMP/GDP standards, conduct aseptic behavior observations, and support operations by driving a culture of Right First Time (RFT) excellence and inspection readiness.
Responsibilities
- Perform real-time reviews of in-process batch records, cleaning logs, and pre-process checks to ensure continuous, compliant production flow.
- Conduct routine aseptic behavior observations and facility walkthroughs to identify and mitigate compliance risks before they impact product quality.
- Provide immediate containment and guidance for quality events on the floor, ensuring accurate initial documentation and process integrity.
- Partner with operational teams during shift huddles to provide quality updates and influence quality behaviors across all manufacturing areas.
Requirements
- Associate's Degree in a science-related field and relevant industry experience or a Bachelor's Degree in a science-related field (Biology, Chemistry, etc.).
- Understanding of aseptic behavior, gowning requirements, and USDA/FDA regulatory compliance within a manufacturing environment.
- Proficiency in utilizing quality and operational electronic systems such as SAP, Veeva, and the Microsoft Office suite.
Qualifications
- Observational competencies and the ability to make confident, risk-based decisions in a fast-paced manufacturing environment.
- An attention to detail with a focus on identifying technical risks and process deviations "in the moment."
- Interpersonal and communication skills used to coach, mentor, and influence operational staff on the floor.
- A proactive mindset with the ability to identify opportunities for process optimization and Right First-Time improvements based on floor observations.
Skills
- Quality and operational electronic systems proficiency (SAP, Veeva, Microsoft Office).
- Understanding of aseptic behavior, gowning requirements, and regulatory compliance.
- Observational and decision-making skills.
- Communication and coaching abilities.
- Proactivity and process improvement mindset.
Benefits
Elanco offers a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: multiple relocation packages for eligible positions, two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO), 8-week parental leave, 9 Employee Resource Groups, annual bonus offering, up to 6% 401K matching, and more.
Pay
Details on pay are not specified in the job posting.
Schedule
The schedule for this position is 2nd and 3rd shifts.