Quality Assurance Specialist II

Position Summary

The Quality Assurance Specialist II provides Quality Assurance oversight for manufacturing and operational activities within a biopharmaceutical or pharmaceutical environment. The role is responsible for batch record review and release support, area release activities, review of electronic systems and manufacturing records, assessment of quality events, and execution of routine compliance activities. The position works closely with Manufacturing, Quality Control, Quality Systems, Validation, Engineering, and other cross-functional teams to ensure that activities are performed in accordance with approved procedures, applicable regulations, and company quality standards. The role also contributes to continuous improvement initiatives and may support additional quality projects as assigned.

Shift: Nights, 6pm-6:30am (2-2-3 Manufacturing schedule)

Core Responsibilities

• Perform batch review and release activities for paper-based batch records and electronic batch records (EBRs), ensuring documentation is complete, accurate, compliant with approved procedures, and assessed for potential product-quality impact.
• Perform or support area release activities, including product changeover, return-to-service assessments, and execution of the Quality Assurance hold process.
• Conduct area audits on a quarterly basis and document findings in accordance with applicable procedures.
• Prepare and review lot genealogy reports to support product traceability and compliance.
• Provide backup support to the Quality Systems function, as needed.
• Assess quality events to determine whether deviation initiation is required in accordance with the applicable DAI process.
• Review, document, and close floor observations within established procedures and timelines.
• Review autoclave run cycles to verify compliance with approved procedures and assess potential impact on product quality.
• Review electronic manufacturing records, including PAS-X and DeltaV electronic logbooks.
• Review PCS/BMS alarms and evaluate relevant information for potential impact on product quality, equipment performance, manufacturing operations, or regulatory compliance.
• Use and support activities associated with applicable site systems and platforms, including GQCLIMS View/Labeler, LAP MODA View, and SAP Labeler, in accordance with assigned access privileges and established procedures.
• Participate in continuous improvement projects, including Lean initiatives, to improve quality processes, compliance, operational efficiency, and right-first-time performance.
• Support other quality-related projects and responsibilities as assigned based on business and site needs.

Required Education and Experience

• Bachelor's degree
• Minimum of three years of experience in a biopharmaceutical or pharmaceutical environment.
• Minimum of one year of experience in Quality Assurance, Quality Control, Validation, or a related quality function.
• Experience reviewing paper-based and electronic manufacturing documentation in a regulated environment.
• Experience working with quality systems, manufacturing records, deviations, observations, and compliance processes.
• Familiarity with electronic manufacturing and quality systems, such as PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, and SAP, is preferred or required according to site needs.

Desired Education

A bachelor's degree in biology, engineering, or a related scientific or technical field is required.

Knowledge, Skills, and Competencies

The Quality Assurance Specialist II should have a working knowledge of applicable GxP requirements, approved procedures, batch documentation practices, manufacturing processes, and quality systems. The role requires strong attention to detail and the ability to identify documentation discrepancies, assess potential quality risks, and escalate issues appropriately. The successful candidate should demonstrate sound quality judgment, effective problem-solving skills, and the ability to work independently while collaborating with cross-functional teams. Strong written and verbal communication skills, effective time management, and the ability to manage multiple priorities are also required. The role requires the ability to review manufacturing and electronic records, interpret process and equipment information, support deviation assessments, and contribute constructively to Lean and other continuous improvement initiatives.