Manager/Senior Manager Quality Assurance

The Manager/Senior Manager Quality Assurance is primarily responsible for overseeing the day-to-day operations of the Quality Assurance team. Performs activities of high level, variety, and complexity to ensure quality and compliance with applicable Federal and State regulatory requirements and guidance documents, including document review, audits, inspections, consulting on quality and compliance issues, training, and trend analysis. Works with Operations to ensure client needs are consistently met. Leads various teams to ensure quality system is continuously improved.

Essential Job Duties:

Manager - Minimum

• Oversee daily operations and provide overall direction and assistance to associates; work with leadership to ensure appropriate staffing of area of responsibility; review/approve associate time sheets
• Interview and select candidates for open positions when needed
• Assess team members by conducting effective performance reviews, and coach associates through necessary performance improvements; onboard as needed
• Host and guide quality audits from clients and external regulatory agencies
• Participate in creation/revision of SOPs for the department as required and ensure policies and procedures are monitored and updated to include regulatory changes
• Communicate with internal clients on open audits, review deviations, investigations and CAPAs
• Provide support as needed on quality management system activities, such as corrective and preventative actions, internal & external assessments, document & records management, ensuring data integrity, etc.
• Support development of system and process improvements that would enhance compliance to requirements
• Identify inefficiencies in processes, workflow, and throughput and implement process improvements to minimize waste
• Accept, complete, and report on special assignments within the agreed upon timeframe
• Work with laboratory operations directors, managers, and supervisors to develop and maintain lists of schedules for responsible tasks
• Maintains accurate quality assurance files, records, and databases, and may perform analysis and trending
• Provides consultation on complex quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed
• Provides training in routine and complex quality and compliance topics for Quality Assurance group and/or other inter-company departments
• Ensure Quality associates have thorough understanding of expected outcomes, troubleshooting, and data analyses by serving as mentor and coach
• Ensure Quality associates are always up to date with training and competency assessments for their areas of responsibility
• Monitor department productivity and ensure appropriate quality metrics are met
• 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
• Demonstrates strong client service skills, teamwork, and collaboration

• Adhere to all quality and safety standards, as well as ensuring compliance with all applicable regulatory agencies
• Adhere to policies and protocols in the laboratory; understand and demonstrate proficiency with quality monitoring activities such as quality indicators and quality reporting related to equipment and monitoring such as KPIs for Quality Meeting
• Participate in data reporting, internal or external client reports as requested, using Excel or other software utilized for reporting, trending, and tracking
• Participate in continual quality improvement projects company-wide
• Other duties as assigned by management

Senior Manager – Fully meets the responsibilities of Manager plus the following:

• Identification of deficiencies or gaps in laboratory testing activities and develop solutions to ensure adequate and robust quality processes
• Optimize processes to comply with existing and new regulatory requirements
• May give input into developing budget
• May give input into development of company strategic plan
• Partner with cross-functional teams to streamline planning, prioritizing initiatives, and addressing challenges proactively

Essential Knowledge, Skills and Abilities:

Manager - Minimum

• Undergraduate degree (BA/BS) in biological, physical, chemical, clinical laboratory science or related field from an accredited university.
• Requires 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, e.g., laboratory technical roles.
• Experience with laboratory regulations and accreditation standards are required
• Working knowledge of good laboratory practices
• Ability to prioritize and decide appropriate course of actions. 
• Strong interpersonal communication, oral and written communication skills
• Ability to interact with associates at every level
• Demonstrated strong writing and composition skills
• Keen attention to detail
• Proficient use and skill of PC based software programs
• Willing 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:

• Requires 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, e.g. laboratory technical roles.
• Requires 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

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

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.