Quality Assurance Associate II- Quality Events Team

Responsibilities

Review, investigate, and manage deviations, non-conformances, and CAPA activities across the organization.

Conduct root cause analyses (RCA) and risk assessments for reported quality issues.

Collaborate with cross-functional teams (Manufacturing, MSAT, QC, Clinical, and R&D) to ensure timely resolution of quality events.

Track and maintain documentation of deviations and CAPAs in compliance with cGMP, FDA, and other applicable regulatory guidelines.

Monitor trends in deviations and CAPAs to identify systemic issues and recommend preventative measures.

Assist in preparing and supporting internal and external audits and inspections.

Develop, update, and maintain SOPs and quality documentation, including but not limited to those related to deviations and CAPA processes.

Provide training to staff on deviations, deviation reporting, and CAPA procedures.

Support continuous improvement initiatives by identifying opportunities to enhance quality processes.

Host/Lead Deviation Review Board (DRB) meetings.

Triage with cross-functional teams to ensure issues are resolved in a timely, quality manner.

Oversee manufacturing areas during critical operations.

Requirements

Education: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field.

Professional Experience: Minimum of 3 years of experience in Quality Assurance within a biotech, pharmaceutical, or related industry.

Strong knowledge of cGMP regulations, FDA/EMA guidance, and industry quality standards.

Proven experience managing deviations, investigations, and CAPA processes.

Excellent analytical, problem-solving, and root cause investigation skills.

Strong written and verbal communication skills, with the ability to prepare clear, compliant documentation.

Ability to work independently and as part of a team.

Attention to detail, organizational skills, and the ability to prioritize multiple tasks in a fast-paced environment.

Work Environment & Physical Demands…