QA Associate, Quality Operations

The QA Associate, Quality Operations is a floor-facing Quality Assurance role that supports day-to-day manufacturing operations in a GMP-regulated environment. This position was opened due to increased team activity and requires strong collaboration with cross-functional partners across Manufacturing, Quality Control, Validation, Engineering, Facilities, and Materials. The role is ideal for an early-career QA professional with hands-on GMP experience who is comfortable working on the production floor and engaging with diverse teams.

Key Responsibilities

• Provide on-the-floor QA support to manufacturing operations, including area clearance, line clearance, and changeover activities to ensure production readiness.
• Support raw material processes, including review and approval of incoming material documentation and release for GMP use.
• Review and approve SOPs, Master Batch Records (MBRs), specifications, risk assessments, and other GMP documentation.
• Generate, revise, and maintain quality-related SOPs and controlled forms.
• Perform executed batch record review and approval to ensure accuracy, completeness, and compliance.
• Review and approve deviations, CAPAs, change controls, and associated investigations within the quality management system.
• Review and approve validation protocols, reports, and protocol executions in alignment with regulatory and site requirements.
• Review and approve QC laboratory qualification and equipment qualification documentation.
• Approve work orders in maintenance systems to verify equipment maintenance and calibration compliance.
• Support inspection readiness activities, partner audits, and regulatory inspections, including document retrieval and subject matter support.
• Collaborate closely with cross-functional teams to drive continuous improvement and promote a strong quality culture.

Technical Skills

• Experience using quality and enterprise systems such as:
• SAP (highly used)
• Veeva Vault (highly used)
• LIMS (plus)
• Infor / CMMS systems (nice-to-have)

• Proficiency in reviewing and managing GMP documentation and quality system records.

Requirements:
Qualifications & Experience

• Bachelor’s degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) required.
• Minimum of 2 years of professional GMP experience; 2–4 years preferred.
• Open to candidates with up to ~10 years of experience, provided GMP exposure aligns with the role scope.
• At least one role with direct, hands-on GMP experience.
• Experience supporting manufacturing or operational environments required.
• Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices (GDP).

Benefits:
• 9-month contract
• Administrative shift