We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic team. This role plays a critical part in upholding our commitment to excellence by ensuring that processes, products, and services consistently meet established quality standards. The ideal candidate brings not only a strong foundation in quality systems and compliance, but also the interpersonal skills necessary to navigate challenging conversations and provide constructive feedback that drives continuous improvement. 

Success in this role requires the confidence and clarity to engage cross-functional teams in difficult discussions, as well as the professionalism and poise to present findings and recommendations to senior leadership. If you are passionate about quality and thrive in a collaborative yet fast-paced environment, we’d love to hear from you.

SUMMARY OF RESPONSIBILITIES

• Responsible for quality activities within assigned department(s), ensuring compliance with regulatory requirements and internal procedures.
• Provides day-to-day quality support to designated departments under general supervision.

ESSENTIAL DUTIES AND FUNCTIONS

• Ensures all observations and deviations are properly investigated and documented.
• Assists with Deviation and Nonconforming Product/Material Reports.
• Evaluates Error Deviations and Nonconforming Reports to identify potential quality system gaps.
• Leads Root Cause Analysis (RCA) meetings during the CAPA process.
• Assists in CAPA plan implementation and Effectiveness Checks.
• Supports implementation of process changes through Change Control, supplemental training, and direct observation.
• Provides Quality training to new hires and conducts ongoing training as needed.
• Acts as a quality leader within their assigned area.
• Performs biannual audits of equipment 
• Maintains active awareness of ongoing operations through direct observation and frequent interaction with Operations staff.
• Identifies and addresses poor practices or conditions and communicates findings to Management.
• Assists supervisors in generating training reports for individuals in the department.
• Contributes to the creation and revision of Standard Operating Procedures (SOPs).
• Collects and analyzes data to identify trends, issues, and supports maintenance of Quality System reporting tools.
• Promotes continuous process improvement and participates in quality initiatives and validation teams.
• Coordinates regular meetings to present quality metrics and key focus areas to QA, QC, and Production leadership.
• Supports final assembly and retention of Device History Records (DHRs).
• Performs additional duties as assigned by leadership.

AREA-SPECIFIC RESPONSIBILITIES

Manufacturing:

• Conducts critical timeline checks and in-process reviews per documentation.
• Reviews batch records/lot files for accuracy and compliance in a timely manner.

Fill/Label:

• Performs final Lot File Reviews to verify completeness and accuracy.
• Conducts process checks and quality reviews for Fill/Label setups and releases.
• Executes inspections based on established procedures to ensure packaging and shipping quality standards.

Distribution:

• Conducts inspections to ensure packaging and shipping operations meet quality standards.
• Performs line clearance checks and reviews Distribution records for accuracy and compliance.

QC Lab:

• Reviews in-process and final QC Device History Records and LIMS data.
• Verifies adherence to good documentation practices and procedural compliance.
• Audits lab using 5S standards and communicates observations.
• Reviews instrument maintenance and reagent logs and follows up as needed.
• Conducts whole blood calibration reviews for completeness and accuracy.

BCT Facility:

• Verifies printed labels prior to application.
• Performs packaging line clearances and record reviews.
• Conducts final product inspections to ensure quality compliance.

POSITION REQUIREMENTS

• Associate degree required; Bachelor’s in STEM or related field preferred.
• 2–3 years of relevant experience may substitute for technical education.
• 1–4 years of related experience in an FDA-regulated manufacturing environment.