Quality Assurance Associate

About the role

The Quality Assurance Associate works closely with the QA Supervisor to ensure that manufacturing operations comply with regulations, ISO standards, and internal SOPs. The role supports a culture of efficiency, attention to detail, and on‑time delivery while identifying and closing quality gaps.

Key responsibilities

• Maintain a QA presence on the production floor and confirm processes.
• Review and approve documentation such as batch records, logbooks, work orders, and procedures.
• Collaborate with Manufacturing/Operations to lead investigations of equipment and process deviations.
• Support batch record reviews, material releases, and coordinate with other QA personnel.
• Make rapid preliminary decisions on deviation scope, product segregation, and corrective actions.
• Participate in cross‑functional deviation investigations using root‑cause and risk‑analysis tools.
• Enforce safety expectations and best practices aligned with SOPs and compliance requirements.
• Utilize systems (Veeva, SCADA, BMS, CMMS, LIMS, lab software) to ensure data integrity.
• Apply statistical analysis to track deviations and identify sources of variability.

Required profile

• Bachelor’s degree in a scientific discipline or equivalent experience.
• Strong self‑management and organizational abilities.
• Excellent written and oral communication skills.
• Ability to work autonomously and influence outcomes without direct authority.

Required skills

• Experience with Veeva, SCADA, BMS, CMMS, and LIMS.
• Proficiency in statistical analysis and applied statistics.
• Root‑cause analysis and risk‑analysis methodologies.

What we offer

• First‑shift schedule (7 am – 4 pm) with occasional weekend support.
• Opportunity to develop a quality‑mindset culture within a manufacturing environment.