QA Associate – Quality Operations

Job Description

Job Summary:

• The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards.
• The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our client site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness.

Duties and Responsibilities:

• Provide raw material support, including review/approval of incoming material documentation and release for GMP use.
• Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities.
• Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents.
• Generate and maintain Quality-related SOPs and controlled forms.
• Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements.
• Review and approve QC laboratory qualification documents, including equipment qualification.
• Perform executed batch record review and approval to ensure accuracy and compliance.
• Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system.
• Support partner audits and regulatory inspections, including document retrieval and subject matter input.
• Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance.
• Collaborate with internal cross-functional teams at the client facility to drive continuous improvement and quality excellence.

Education and Experience:

• Bachelor’s degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience.
• 2–4 years of GMP experience in Quality, Manufacturing, or QC.
• Experience with quality systems (e.g., Veeva, SAP) is a plus.

Knowledge, Skills and Abilities:

• Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices.
• Strong attention to detail.
• Organizational skills.
• The ability to communicate effectively across teams.

Interview Process:

• Round 1: 1:1 with manager  (30 min).
• Round 2: Panel interview (45 min).