About this role
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 sheetsInterview and select candidates for open positions when neededAssess team members by conducting effective performance reviews, and coach associates through necessary performance improvements; onboard as neededHost and guide quality audits from clients and external regulatory agenciesParticipate in creation/revision of SOPs for the department as required and ensure policies and procedures are monitored and updated to include regulatory changesCommunicate with internal clients on open audits, review deviations, investigations and CAPAsProvide 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 requirementsIdentify inefficiencies in processes, workflow, and throughput and implement process improvements to minimize wasteAccept, complete, and report on special assignments within the agreed upon timeframeWork with laboratory operations directors, managers, and supervisors to develop and maintain lists of schedules for responsible tasksMaintains accurate quality assurance files, records, and databases, and may perform analysis and trendingProvides consultation on complex quality and compliance topics in areas of expertise and assists with quality improvement initiatives as neededProvides training in routine and complex quality and compliance topics for Quality Assurance group and/or other inter-company departmentsEnsure Quality associates have thorough understanding of expected outcomes, troubleshooting, and data analyses by serving as mentor and coachEnsure Quality associates are always up to date with training and competency assessments for their areas of responsibilityMonitor department productivity and ensure appropriate quality metrics are metResolve problems and ensure that appropriate corrective and preventive actions are taken when deficiencies or errors are found ensuring routing and escalation to department supervisors/managerDemonstrates strong client service skills, teamwork, and collaborationAdhere to all quality and safety standards, as well as ensuring compliance with all applicable regulatory agenciesAdhere 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 MeetingParticipate in data reporting, internal or external client reports as requested, using Excel or other software utilized for reporting, trending, and trackingParticipate in continual quality improvement projects company-wideOther duties as assigned by managementSenior 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 processesOptimize processes to comply with existing and new regulatory requirementsMay give input into developing budgetMay give input into development of company strategic planPartner 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 requiredWorking knowledge of good laboratory practicesAbility to prioritize and decide appropriate course of actions. Strong interpersonal communication, oral and written communication skillsAbility to interact with associates at every levelDemonstrated strong writing and composition skillsKeen attention to detailProficient use and skill of PC based software programsWilling to work outside normal business hours as job dictatesAbility to identify aberrant data and potential quality/compliance concerns escalating to managementFamiliarity with six sigma scoring as applied to metrics/KPIs for qualitySenior 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 managementAbility to see broader picture and longer-term impact on organizationPhysical 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 overheadAbility 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 settingAbility 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 poundsAbility 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 decisionsAbility 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.