QA Associate

About the role

The QA Associate works closely with the QA Supervisor to ensure that manufacturing operations meet regulatory, ISO, and internal SOP requirements. This position supports the development of a quality‑focused mindset and helps maintain efficient, on‑time delivery while identifying operational and quality gaps.

Key responsibilities

• Maintain a Quality Assurance presence on the manufacturing floor and confirm processes.
• Review and approve documentation such as batch records, logbooks, work orders, and procedures.
• Collaborate with Manufacturing/Operations to lead or support investigations of equipment and process deviations.
• Assist QA team with batch record reviews, material releases, and product segregation decisions.
• Perform rapid preliminary evaluations of deviations and recommend corrective actions or escalation.
• Participate in cross‑functional deviation investigations using root‑cause and risk‑analysis tools.
• Promote safety, SOP compliance, and best practices across the site.
• Utilize paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab software) to ensure data integrity.
• Apply statistical methods to track deviations and identify sources of variability.

Required profile

• Excellent interpersonal, written, and oral communication skills.
• Ability to build productive, customer‑centric relationships with colleagues and partners.
• Strong self‑management and organizational abilities; capable of working autonomously and in a team.
• Influential without direct authority and respectful of process owners and subject‑matter experts.

Required skills

• Veeva
• SCADA
• BMS
• CMMS
• LIMS
• Laboratory instrument software
• Applied statistics
• Root‑cause analysis tools
• Risk analysis tools