Senior Quality Assurance Specialist

Are you a quality-driven professional who thrives in a fast-paced environment, tackles complex issues head-on, and pivots seamlessly when priorities shift? We’re looking for a highly motivated, experienced Quality Assurance professional to lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations.  The Senior Quality Assurance Specialist oversees the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Senior Quality Assurance Specialist ensures product safety, product quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement.

PRIMARY RESPONSIBILITIES:

• Operation and monitoring of facility, product, equipment and associated software.

• Timely responses to resolution of alarm notifications from the facility systems and product storage systems.

• Support in product inventory activities.

• Execution of product movement during emergencies and planned maintenance.

• Maintenance of equipment and safety equipment to ensure quality product storage and employee safety.

• Host and lead state and federal inspectors during inspections.

• Continuously evaluate progress toward objectives adapting them to meet customer and business needs.

• Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.

• Serve on Teams such as CAPA, Deviations, and Nonconformances; represents or serves as escalation for Quality on Core Teams.

• Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.

• Support the set up and maintenance Quality Systems for Document Control, CAPA, Internal Audit, and Complaint investigations.

• Comply with all quality policies, procedures, and practices through consistent application of sound quality assurance principles.

• Other duties as assigned.

• This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

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QUALIFICATIONS:

• Bachelor's degree in science, engineering, medical technologist, other relevant discipline, or equivalent required.

• 5+ years of work experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience

KNOWLEDGE, SKILLS, AND ABILITIES:

• Prior quality or operational experience in a medical setting is a plus.