Quality Assurance Specialist

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Quality Assurance Specialist position will join the Quality Assurance team in supporting quality operations for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment.

Critical Performance Areas

• Ensure work is executed in compliance with GMP regulatory requirements and SOPs
• Interpret information with a focus on quality using scientifically sound, risk-based approaches
• Work across multiple quality processes within the QMS to support daily operations and ensure delivery of reliable data to clients
• Provide timely and effective communication to impacted stakeholders across different functional areas
• Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site

Essential Job Functions

• Ensure documentation supporting site quality processes is clear, compliant, and acceptable for use in a GMP testing environment
• Drive deviations, non-conformities, OOS investigations to closure and ensure adherence to procedures; this includes but is not limited to ensuring effective root cause analysis has been conducted, collaborating with stakeholders on suitable corrective and preventive actions, and ensuring that conclusions are supported with adequate information and a clear rationale
• Own and coordinate or act in approver capacity for change controls
• Support GMP training for peers and stakeholder teams
• Monitor and report on metrics and KPIs; collaborate with stakeholders to improve quality process efficiency and effectiveness
• Support the Quality Assurance organization in the coordination of, preparation for, and follow up on internal and external audits and inspections.

Requirements

• B.A/B.S. in Life Sciences with 3+ years relevant experience in a quality-facing role (or equivalent combination of education and experience)
• Experience working in GMP testing environment
• Experience in processing quality events (i.e., deviations, laboratory non-conformities, OOS/OOT/OOE investigations, CAPAs, change controls) per applicable operating procedures
• Experience supporting internal or external audits and health authority inspections

Other Desired Skills/Abilities

• Working with QMS (e.g., MasterControl) and LIMS (e.g., Labware) IT systems
• Have a developing subject matter expertise in one of the following areas of the QMS: controlled document management, GMP training program management, data integrity program management, audit/inspection management
• Excellent organizational skills and ability to work and make decisions independently
• Strong written and verbal communication skills

This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias US does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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