QA Specialist (Drug Product)

Role Summary

QA Specialist (Drug Product) supporting Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. Roles may involve start-up activities, program development, and on-the-floor quality oversight in a cleanroom environment.

Responsibilities

• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team.
• Assess existing procedures/documents for inclusion of drug product operations; identify path forward when current documents are inadequate.
• Develop, write, review, and approve SOPs, specifications, and other documents (operation and facility SOPs, quality training, batch documentation, etc.).
• Maintain project timelines to support evolving business needs.
• Perform on-the-floor quality review of documents (equipment logs, training records, testing results, batch records, and supporting documents).
• Review and approve documents (electronic and paper-based).
• Execute daily operations per management in a multifaceted environment.
• Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
• Provide mentorship during on-the-floor manufacturing.
• Support audits, inspections and investigations.
• Perform quarantine, segregation of material and line clearances.
• Contribute to continuous improvement initiatives.

Qualifications

• Associate QA Specialist ‚Äì 2+ years
• QA Specialist ‚Äì 4+ years
• Sr QA Specialist ‚Äì 6+ years
• May substitute proven experience for education requirement. Level determined by qualifications relevant to the role.

Skills

• Ability to multi-task and own multiple projects while adhering to defined timelines.
• Experience collaborating with cross-functional teams.
• Ability to develop performance measures and reports for management.
• Gowning for an ‚ÄúA‚Äù classification work environment.

Education

• Bachelor‚Äôs degree in Life Sciences or related field required; may substitute with relevant experience.

Additional Requirements

• Gowning and cleanroom environment requirements: full cleanroom attire and related precautions.
• On-site work may be required; local policy and expectations vary by location.