Quality Assurance Specialist II

The Quality Assurance team is responsible for reviewing and supporting equipment validations, process validations, change control, technical transfers, quality planning, gap assessments, and internal and external audit activities. Validation responsibilities include performing risk assessments to determine the appropriate extent of validation required. The QA Specialist II is responsible for writing and/or reviewing validation protocols and reports and supporting documentation associated with validation and change control processes.

The application of risk assessment methodologies is required to support a fast-paced Change Control system while maintaining applicable IVD regulatory, quality system, and compliance requirements. Responsibilities include evaluating proposed changes for quality and regulatory impact, identifying potential risks and gaps, and ensuring appropriate controls and documentation are established.

Quality planning responsibilities include supporting the development, implementation, and maintenance of quality plans for new and existing products, processes, projects, and quality system initiatives. The QA Specialist II collaborates with cross-functional teams to define quality requirements, deliverables, acceptance criteria, risk controls, and quality activities throughout the applicable product and process lifecycle. This position also monitors quality plan activities and deliverables to ensure requirements and commitments are completed in accordance with established timelines.

Gap assessment responsibilities include conducting and/or supporting assessments of processes, procedures, documentation, and quality system elements against applicable internal requirements, standards, regulations, and business requirements. The QA Specialist II identifies and documents gaps, evaluates associated quality and compliance risks, recommends appropriate remediation activities, and partners with process owners and cross-functional teams to develop and track action plans through completion. Gap assessments may be performed in support of new or revised requirements, quality system improvements, inspection readiness, site or process changes, and other compliance initiatives.

Technical Transfer activities include reviewing protocols and reports and collaborating cross-functionally to develop robust manufacturing processes, QC methods, specifications, and documentation supporting the Device Master Record (DMR). The QA Specialist II provides Quality oversight throughout transfer activities to help ensure applicable quality and regulatory requirements are appropriately incorporated and documented.

Audit responsibilities include supporting and participating in internal audits, external audits, and regulatory inspections, as applicable. The QA Specialist II may assist with audit preparation and readiness activities, review documentation for compliance with established procedures and applicable regulatory requirements, gather and present objective evidence, respond to auditor requests, and support the documentation, investigation, and timely closure of audit observations and findings. Responsibilities may also include supporting corrective and preventive actions (CAPAs) resulting from audits, tracking commitments through completion, and collaborating with cross-functional teams to maintain a state of inspection readiness and drive continuous improvement.

The QA Specialist II may serve on Core Teams or assist Core Teams in developing processes and transferring knowledge across functional groups. This position is highly cross-functional and requires independent judgment, effective communication, attention to detail, risk-based decision-making, and adherence to established schedules and commitments while working under moderate levels of guidance.

• Must be legally authorized to work in the United States without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening.