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Syner-G · 1 day ago

Quality Associate, Commissioning & Validation

Holly Springs, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

Syner-G is a strategic biopharma product development and delivery partner, dedicated to enhancing the quality of life through innovative therapies. The Quality Associate role involves supporting the commissioning and validation of a manufacturing facility, ensuring compliance with GMP standards, and collaborating with technical teams to maintain project timelines.

Health CareManufacturingPharmaceutical

No H1B

Responsibilities

Commissioning and Qualification Review commissioning, IQ, OQ, and PQ protocols and reports for GMP equipment and systems

Verify execution aligns with approved protocols and regulatory expectations

Ensure deviations, discrepancies, and punch list items are documented and resolved

Confirm traceability from requirements through execution and final approval

Quality Oversight Provide quality review and approval of validation deliverables

Ensure documentation meets data integrity and GMP standards

Support risk assessments, impact assessments, and change controls tied to commissioning activities

Escalate compliance risks clearly and early

Cross-Functional Collaboration Work directly with engineering, automation, facilities, and manufacturing teams

Support technical teams by clarifying quality expectations and documentation needs

Help teams close gaps without unnecessary delays

Schedule and Readiness Support Track review timelines and follow up to maintain progress

Support inspection readiness related to commissioning and validation activities

Assist with responses to internal or external audit questions

Qualification

GMP manufacturing experienceValidation lifecycle knowledgeCommissioning experienceFDA regulatory understandingDocumentation standards familiarityClear communicatorComfortable with technical teamsPractical mindsetDetail-oriented