Manager/Senior Manager Quality Assurance

About the role

The Manager/Senior Manager Quality Assurance oversees the day-to-day operations of the Quality Assurance team. They ensure quality and compliance with applicable Federal and State regulatory requirements and guidance documents, conduct audits, participate in creating SOPs, and support system and process improvements.

Responsibilities

• Oversee daily operations and provide overall direction and assistance to associates
• Interview and select candidates for open positions when needed
• Assess team members by conducting effective performance reviews and coaching associates through necessary performance improvements
• Host and guide quality audits from clients and external regulatory agencies
• Communicate with internal clients on open audits, review deviations, investigations, and CAPAs
• Support development of system and process improvements that enhance compliance to requirements
• Identify inefficiencies in processes, workflow, and throughput and implement process improvements to minimize waste
• Provide consultation on complex quality and compliance topics in areas of expertise and assist with quality improvement initiatives as needed
• Provide training in routine and complex quality and compliance topics for Quality Assurance group and/or other inter-company departments
• Maintain accurate quality assurance files, records, and databases, and perform analysis and trending
• Resolve problems and ensure that appropriate corrective and preventive actions are taken when deficiencies or errors are found, ensuring routing and escalation to department supervisors/manager

Qualifications

• Manager - Minimum: Undergraduate degree (BA/BS) in biological, physical, chemical, clinical laboratory science or related field from an accredited university; minimum of two years’ experience in a regulated clinical laboratory (CAP/CLIA and/or GxP) in Quality Assurance, Laboratory Quality processes, Quality Improvement, or similar experience in Laboratory process ownership; working knowledge of good laboratory practices; ability to prioritize and decide appropriate course of actions; strong interpersonal communication, oral and written communication skills; keen attention to detail; proficient use and skill of PC based software programs; willingness to work outside normal business hours as job dictates; ability to identify aberrant data and potential quality/compliance concerns escalating to management; familiarity with six sigma scoring as applied to metrics/KPIs for quality.
• Senior Manager – Fully meets the responsibilities of Manager plus the following: minimum of 5 years’ experience in a regulated clinical laboratory (CAP/CLIA and/or GxP) in Quality Assurance, Laboratory Quality processes, Quality Improvement, or similar experience in Laboratory process ownership; minimum of 3 to 5 years' experience in leadership experience demonstrating success in Quality Assurance strategy operation, and incident management; ability to see broader picture and longer-term impact on organization; requires minimum of 3 to 5 years' experience in leadership experience demonstrating success in Quality Assurance strategy operation, and incident management.

Physical Requirements

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
• Ability to stand for extended periods of time as necessary in the laboratory (4 or more hours)
• Ability to lift and move items weighing up to 15 pounds
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions
• Ability to travel – car, airplane, other

Additional Information

The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. Excellent full time benefits including comprehensive medical coverage, dental, and vision options; life and disability insurance; 401(k) with company match; paid vacation and holidays. Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.