Quality Associate-II

Description

• Provide front line day-to-day assistance on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality.
• Support during assigned Shift, with the requirement to support plant overtime and planned shutdowns when applicable.
• Provide technical assistance on review and approval of department-related procedural changes, product quality concerns, reinspections, new product introductions, and protocols.
• Support timely follow-up on quality exceptions and their preventative/corrective actions.
• Support initiation/investigation and approvals of non-conformance events in the Trackwise system.
• Act as SME for Electronic Batch Record (EBR) and SPC or equivalent experience.
• Perform change control assessments/executions and approvals.
• Ensure control of defective WIP materials (quarantine, retention, and disposal areas) to keep segregation, movement, documentation, and timely follow-up within the plant in sync with regulatory and compliance requirements.

Qualifications

• University Degree or equivalent experience, Bachelor of Science or equivalent experience.
• 1 – 3 years’ experience in manufacturing and quality roles.
• Prior experience working in a GMP setting.
• Knowledge of cGMP, ISO, and regulatory standards.
• Diligent with the ability to work effectively under pressure.
• Strong written and verbal communication abilities, negotiation capabilities, and the capacity to collaborate with individuals at every level of the organization.
• Ability to build positive relationships and partner with internal and external collaborators.
• Strong ability to balance multiple priorities.
• Strong analytical and problem-solving skills with critical thinking abilities.
• Intermediate to Advanced proficiency in MS Office Suite.