QA Specialist, Drug Product

About the role

The QA Specialist, Drug Product (DP) helps drive the Quality oversight for the direction of all DP Manufacturing processes through to operational readiness during project phase. This role oversees QA’s day-to-day activities and resolution or mitigation of issues.

Responsibilities

• Supports the development of documents, processes and procedures for the Drug Product program.
• Affirms the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state from startup into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation including risk and impact assessments, product and process equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans and validation summary reports.
• Generates, reviews and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
• Generates, reviews and approves QA documentation, procedures and processes for operational readiness objectives and QA support of manufacturing operations in a current Good Manufacturing Practice (cGMP) regulated facility.
• Ensures the fulfillment of project and operational quality objectives within desired timelines.
• Provides Manufacturing shop floor support including Acceptable Quality Limit (AQL), critical process step verification, issue resolution, line clearance and alarm response.
• Participates in optimization or improvement initiatives; supports regulatory agency and third-party inspections.
• Performs other duties, as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering or equivalent with 2+ years of applicable industry experience; OR, Master’s degree in Life Sciences or Engineering with 0+ years of applicable experience.
• 1+ years of experience working in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Preferred Requirements

• High level understanding/familiarity of validation of production equipment, hygienic utilities, quality systems, automation, methodologies, manufacturing and IT Systems.
• Understanding of GAMP5, Data Integrity and application of 21 CFR Part 820 and Part 11.
• Understanding of formulation, aseptic filling and/or visual inspection.
• Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, Veeva, Kneat validation software, and/or PAS-X.
• Experience with startup Projects or initiatives.